Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

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Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

Background

In 2017, the U.S. Food and Drug Administration (FDA or Agency) published a Pharmaceutical 

Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Controlled Terminology 

document as part of Federal Register Notice (FRN)[ https://www.regulations.gov/docket/FDA-2017-N2166]. That document proposed structured data standards for a set of electronic common technical 

document (eCTD) Module 3 content. There was a large volume of comments received from the 

industry in response to the FRN with overall support for structuring Module 3 content and detail 

comments on the data elements and controlled terminologies. The comments and feedback were 

incorporated into the structured data elements and controlled terminology. This document is a 

follow-up of the previous FRN document. While the previous document focused on introducing the 

structuring and standardization of some parts of eCTD Module 3 and solicited feedback from the 

industry, this document is focused on representation of those published PQ/CMC structured data 

elements in the new healthcare data exchange standard from Health Level 7 (HL7) called Fast Health 

Interoperability Resources (FHIR). FDA is now seeking feedback and comments on how the PQ/CMC 

data elements are represented in HL7 FHIR. The FDA team has worked collaboratively with the 

members of various HL7 work groups, including the Biomedical Research and Regulation (BR&R) 

Workgroup. The BR&R workgroup includes participants from teams working on the FHIR 

representation of related requirements from the European Medicines Agency (EMA) and Health 

Canada. FDA is specifically seeking comments on the mapping of the PQ/CMC data elements to the 

various FHIR Resources. This is not a technical specification or an implementation guide. The actual 

implementation Guide (IG) will be a separate document and will be published after the HL7 FHIR R5 is 

officially published. This PQ/CMC information would be submitted in the Common Technical 

Document (CTD) as defined by the International Council for Harmonisation’s (ICH) CTD1.

Several of the HL7 FHIR Resources related to medicinal products and substances represent the 

concepts described by the International Organization of Standardization for the Identification of 

Medicinal Products (ISO IDMP) standards. Many Docket comments to the 2017 PQ/CMC Federal 

Register Notice emphasized the importance of IDMP conformance [ref]. The IDMP suite of standards 

are a result of a need to standardize the definition of medicinal product and substance information to 

facilitate the unique identification and exchange of such information in regulatory submissions. 

PQ/CMC team has worked actively with EMA representatives in aligning the PQ/CMC and IDMP 

representations in FHIR resources, where relevant; but note that there are many IDMP code lists left

to regional terminologies.

For consistency of product quality data across FDA centers, the draft standardized data elements and 

terminologies were created by an Agency workgroup comprised of Subject Matter Experts (SMEs) from 

the Center for Drug Evaluation and Research (CDER), the Center for Veterinary Medicine (CVM), and 

the Center for Biologics Evaluation and Research (CBER). Please note that data element definitions 

1 The Common Technical Document for the Registration of Pharmaceuticalsfor Human Use: Quality – M4Q (R1)
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provided here have been developed for purposes of review of information in Module 3 of the eCTD.

For the most current information on the PQ/CMC effort, please go to FDA’s Data Standards page, 

https://www.fda.gov/industry/fda-resources-data-standards.

This document provides a draft design of FHIR profiles that contain the data elements and 

terminologies associated with PQ/CMC topics and aligned with data elements that are typically 

included in Module 3 of the electronic Common Technical Document (eCTD)2regulatory submissions.

It is not intended to be comprehensive in covering all eCTD product quality information, only those 

concepts that were considered amenable to structuring and would bring value to the quality review 

process. The existing HL7 v3 eStability data standard has been withdrawn from HL7 and the scope 

and content of eStability is now covered under PQ/CMC as FHIR representation. The submission of 

structured data in a standardized format should increase the efficiency of FDA’s review of PQ/CMC 

data contained in the Module 3 of eCTD submissions for a New Drug Application (NDA), an

Investigational New Drug Application (IND), a Biologics License Application (BLA), an Abbreviated New 

Drug Application (ANDA), a New Animal Drug Application (NADA), an Abbreviated New Animal Drug 

Application (ANADA), an Investigational New Animal Drug (INAD), Generic Investigational New Animal 

Drugs (JINADs), and a Master File (MF).

Review of these elements and definitions should be conducted by personnel in pharmaceutical 

companies who will be able to determine if the element definitions and controlled terminologies are 

understandable and meaningful. Since this document is providing the additional representation and 

mapping of the PQ/CMC data elements to HL7 FHIR, personnel from the information technology 

department of the pharmaceutical companies are encouraged to review and provide feedback on the 

FHIR representation and mapping. A basic understanding of FHIR would aid in the review. 

Understanding HL7 FHIR

HL7 FHIR is a standard for exchanging healthcare information electronically. It is an extensive Health IT 

standard whose communities range from hospital care to regulatory processes. FHIR is a set of 

modular components called Resources. They document the basic data exchange format and data 

model behind its exchange. Resources define the component data elements, constraints, and 

relationships. FHIR supports a mechanism called profiles to constrain and/or extend a resource 

definition and bind to it a specific vocabulary for a specific use case. PQ/CMC has leveraged twelve 

FHIR resources and at present designed six PQ/CMC foundational FHIR profiles: Drug Substance, Drug 

Product, Batch Formula, Quality Specification, Batch Analysis, and Stability. These six profiles are presented 

in this document. 

• The FHIR mapping presented in this document is bound to a pre-R5 ballot draft of HL7 FHIR. All 

the Medication Definition resources that are used by PQ/CMC were balloted in this release 

(R5). As with any balloting in a Standards Development Organization (SDO), it is anticipated 

that once all the FHIR R5 ballot comments are reconciled some parts of the mapping presented 

in this document will change.

• Information about FHIR and specifically the FHIR R5 release can be found at 

2 Electronic Common Technical Document v3.2.2
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https://build.fhir.org/branches/master/.

• Specific examples explaining some of the Medication Definition resources are explained here 

https://build.fhir.org/medication-definition-module.html.

The PQ/CMC domain scope for this entire effort has been divided into two phases. 

Phase 1 covers the following topics: Drug Product definition, Drug Substance definition, Quality 

Specification, Batch Formula, Batch Analysis and Stability.

Phase 2 data standards are under development, and will cover the following topics: Drug Product 

Manufacturing and Drug Substance Manufacturing.

The scope of this document is limited to Phase 1 domains only. FDA will provide the structuring of 

Phase 2 domains in the near future. 

# High Level PQ/CMC Domain Mapping HL7 FHIR Resource Name

1 Drug Product definition MedicinalProductDefinition

2 Substance definition SubstanceDefinition

3 Ingredient definition Ingredient

4 Drug Product packaging definition PackagedProductDefinition

5 Stability Study ResearchStudy

6 Instance of Substance Substance

7 Instance of Product, Batch Medication

8 Product and Substance testing results Observation

9 Stability Reports, Testing reports DiagnosticReport

10 Specification PlanDefinition

11 Batch Formula ActivityDefinition

12 Drug manufacturers, API manufacturers, Testers, Suppliers Organization

Figure 1: High Level PQ/CMC domains mapped to FHIR Resources

These twelve (12) FHIR Resources have been arranged together to support the PQ/CMC domains in 

scope of Phase 1. The first four FHIR resources from the above list (MedicinalProductDefinition, 

SubstanceDefinition, Ingredient and PackagedProductDefinition) have their origins in the IDMP 

concepts in support of ISO IDMP 11615 and 11238 standards. PQ/CMC project has leveraged these 

resources where relevant and extended them to support PQ/CMC requirements.

Additional profiles will describe these main profiles as compositions following the FHIR designation 

of a bundle as type document. The compositions will align with the eCTD sections. The 

compositions will themselves be a profile. In FHIR, a profile can be based on other profiles by 

applying further constraints to another profile. In this manner, the conceptual entity can be 

presented in FHIR logically and then be broken into smaller files that will correspond to the 

requirements of the eCTD sections.

Figure 2 below shows how the 12 FHIR Resources are related to each other through references. 
Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

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Figure 2: Collection of FHIR Resources in scope of Phase 1 PQ/CMC

This draft document is organized into the following eight sections:

Section 1: Drug Substance Data Elements, beginning on page [7];

Section 2: Drug Product Data Elements, beginning on page [17];

Section 3: Batch Formula Data Elements, beginning on page [30];

Section 4: Quality Specification Data Elements, beginning on page [34];

Section 5: Batch Analysis Data Elements, beginning on page [43];

Section 6: Stability Data Elements, beginning on page [59];

Section 7: PQ/CMC Controlled Terminology, beginning on page [66];

Section 8: Glossary, beginning on page [97].

Each data element section contains two tables: the first identifies and describes the PQ/CMC data 

elements, the second provides the mapping of each data element to the appropriate FHIR resource 

element.

PQ/CMC Data Elements

The table in each section identifies the structured data elements and their details that are in scope 

of that section. The majority of the content of the Data Elements table is the same as was 

published by FDA as part of the FRN in 2017. There are updates based on industry feedback as 

well as further clarification, refinement, and structuring. The data elements have been grouped 

together under a larger logical grouping. The columns in the data element tables are as follows:
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• Data Element Name Definition: Represents the description of the data element and is 

intended to provide the semantic clarity for the data element. To further clarify the 

definition, examples and additional notes have been provided. Also, the source of the 

definition has been captured and added after the definition. Where possible authoritative 

sources such as the CFR, USP or ICH were relied on. The source most often documented is 

“Subject Matter Expert (SME) Defined.” The SMEs for this effort are the PQ/CMC reviewers 

from CDER, CVM and CBER.

• Data Type: Identifies the data format or representation and can contain a range of values 

or specific types. For example, date, text.

• Cardinality: The number of occurrences of the element. 

• Business Rule (BR)/Comments: Provides element specific business rules where relevant or 

any other additional comments for clarification.

HL7 FHIR Mapping

The FHIR Mapping tables show the PQ/CMC Data Elements paired with the FHIR resource element it’s 

mapped to. The FHIR Mapping tables show the FHIR resources as a tree structure and has following 

columns:

• PQ/CMC Data Element Name: Denotes the name of the PQ/CMC element. If the element name is 

Italicized, the element is not in the Data Elements and FHIR Mapping table and is either required by 

the FHIR resource or added to give context to the Data Elements. Contextual additions are typically 

textual, references to other resources for identification of the information or grouping articles.

• FHIR Resource Element Name: The name of the FHIR element in the resource. The FHIR 

element is prefixed by an icon that denotes the underlying type of the content. The icons are 

described below. The names are hyperlinked to the FHIR specification for additional 

information about the FHIR construct.

• FHIR Data Type: The type of the element hyperlinked to the definition of the type on the HL7 FHIR 

website.
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Key to the Icons in the FHIR Mapping Tables in each section

Symbol Meaning

The base element for a resource.

An element that is part of the resource and has elements within it defined in the same resource or profile.

An element which can have one of several different types.

An element of a data type which describes an element that has a value attribute/property. These are also 

known as primitive types and their names start with a lower-case letter.

An element of a data type which describes an element that has other elements. These are known as complex 

types. All complex type names defined in this specification start with an upper-case letter.

An element that contains a reference to another resource. Since there are no REST endpoints for the PQ/CMC 

implementation, references are contained resources within the XML file.

This element has the same content as another element defined within this resource or profile.

Introduction of a set of slices. Refer to the FHIR website for explanation of slice and slicing.

A complex extension - one with nested extensions.

An extension that has a value and no nested extensions.
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Section 1: Drug Substance Data Elements and FHIR Mapping

This section covers the properties of drug substance nomenclature, characterization, control of materials and impurities. This information is 

typically submitted in eCTD sections -- 3.2.S.1.1; 3.2.S.1.2; 3.2.S.3.1; 3.2.S.2.3; 3.2.S.2.4 (for intermediates ONLY); 3.2.S.3.2

PQ/CMC Data Elements

# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardin

ality

Business Rule

(BR)/Comments

1 Substance 

Name

A commonly used name or a systematic name assigned to the material or 

compound. [Source: SME Defined]

Examples: acetaminophen; acetamide, N- (4-hydroxyphenyl)-; 4-

hydroxyacetanilide; rituximab, OkT3

Text 0..* BR: Substance Name and 

the following identifiers 

(CAS, INN, USAN, IUPAC) 

collectively are providing 

the name, depending on 

the Substance Type (in 

IDMP), one of these 

identifiers is mandatory.

2 CAS Number Chemical Abstract Service (CAS) Registry Numbers (often referred to as CAS RNs 

or CAS Numbers) are used to provide identifiers for chemical substances. A CAS 

Registry Number itself has no inherent chemical significance but provides a way 

to identify a chemical substance or molecular structure when there are many 

possible systematic, generic, proprietary or trivial names. [Source: Adapted 

from CAS.org]

Example: CAS [103-90-2]

Text 0..1

3 INN International Nonproprietary Names (INN) is a unique name that is globally 

recognized and is public property. A nonproprietary name is also known as a 

generic name. 

Note: International Nonproprietary Names (INN) facilitate the identification of 

pharmaceutical substances or active pharmaceutical ingredients [Source: 

http://www.who.int/medicines/services/inn/en/]

Example: Paracetamol

Text 0..1

4 USAN A unique nonproprietary name assigned to drugs and biologics and assigned by 

the United States Adopted Names Council [Source: SME Defined]

Example: acetaminophen

Text 0..1
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# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardin

ality

Business Rule

(BR)/Comments

5 IUPAC Name A name assigned to a chemical substance according to the systematic 

nomenclature rules defined by the International Union of Pure and Applied 

Chemistry (IUPAC) [Source: SME Defined]

Example: N- (4-hydroxyphenyl)acetamide

Text 0..1

6 UNII The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, 

alphanumeric identifier based on a substance’s molecular structure and/or 

descriptive information. [Source: 

http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystemUniqueIngredientIdentifierUNII/]

Example: 362O9ITL9D 

Note: If a UNII does not exist, please go to 

http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystemUniqueIngredientIdentifierUNII/

Text 0..1 UNIIs are not required 

for:

Human Cells, Tissues and 

Cellular and Tissue-Based 

Products (HCT/Ps) that 

are regulated solely 

under section 361 of the 

Public Health Service Act 

and 21 CFR part 1271.

Blood and blood 

components intended for 

transfusion (must be 

labeled consistent with 

the requirements in 21 

CFR 606.121 (container 

label) and 606.122 

(circular of 

information)), or labeling 

associated with licensed 

in vitro diagnostic (IVD), 

Blood Grouping Reagents 

(BGR) products.

7 ISBT 128 It is the global standard for the terminology, identification, coding and labeling 

of medical products of human origin (including blood, cell, tissue, milk, and 

organ products). [Source: https://www.iccbba.org/]

Text 0..1 BR: Applicable to blood 

products.

8 Company Code An internal identifier assigned by the sponsor to this drug substance. [Source: 

SME Defined]

Text 0..*

9 Molecular The average mass of a molecule of a compound compared to 1/12 the mass of 

carbon 12 and calculated as the sum of the atomic weights of the constituent 

Numeric 0..1
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# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardin

ality

Business Rule

(BR)/Comments

Weight atoms. [Source: Merriam Webster]

10 Molecular 

Weight UOM

The labeled unit of measure for the molecular weight. [Source: Adapted for NCI 

EVS C117055]

Code 0..1 BR: Required if Molecular 

Weight is not null.

11 Molecular 

Formula

An expression which states the number and type of atoms present in a 

molecule of a substance or sequence for biotechnology products. [Source: SME 

Defined]

Text 0..1

12 Substance 

Structure 

Graphic

A pictorial representation of the structure of the drug substance. [Source: SME 

Defined]

Note: Refer to the "Acceptable File Formats for use in eCTD" 

Example: This is the representation of the molecule CH3OH, or the sequence 

SHLVEALALVAGERG.

Graphic 0..1 BR: Required for Small 

Molecules.

13 Structural 

Representation

A machine-readable representation of the structure of the chemical. [Source: 

SME Defined]

Examples: SDF, MOLFILE, InChI file (small molecule), PDB, mmCIF (large 

molecules), HELM.

Text 0..*

14 Structural 

Representation 

Type

A format name or abbreviation that identifies a file structure. [Source: SME 

Defined]

Examples: SMILES, MOLFILE, HELM.

Code 0..1 BR: Required if Structural 

Representation is 

provided.

15 Polymorphic 

Form 

Identification

The designation of the polymorphs present in the drug substance. [Source: SME 

Defined]

Example: Polymorph A 

Text 0..*

16 Substance 

Characterization 

Technique

The technique used to elucidate the structure or characterization of the drug 

substance. [Source: SME Defined]

Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay.

Text 1

17 Analysis Graphic The pictorial representation of the data. [Source: SME Defined]

Examples: spectrum, chromatogram.

Note: Refer to the "Acceptable File Formats for use in eCTD" 

Graphic 0..* BR: Multiple graphics are 

typically seen more often 

in Biologics. Some 

techniques produce 
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# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardin

ality

Business Rule

(BR)/Comments

Example: This is the representation of the instrumental output for the molecule 

-- CH3OH

multiple graphics.

18 Analytical 

Instrument Data 

File 

The transport format for data exchange. [Source: SME Defined]

Example: JCAMP, ADX, ADF.

Text/ 

Binary

0..*

19 Analytical 

Instrument Data 

File Type

A format name or abbreviation that identifies a file structure. [Source: SME 

Defined]

Examples: Joint Committee on Atomic and Molecular Physical Data (JCAMP), 

Analytical Information Markup Language (AnIML).

Text 0..1 BR: Required if Analytical 

Instrument Data File is 

provided.

20 Substance 

Component 

Name

Any raw material intended for use in the manufacture of a drug substance. 

[Source: SME Defined] 

Note: for use as an agent in manufacture of a drug substance

Text 1..*

21 Quality 

Standard

The established benchmark to which the component complies. [Source: SME 

Defined] Examples: USP/NF, EP, Company Standard

Code 1..*

22 UNII The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, 

alphanumeric identifier based on a substance’s molecular structure and/or 

descriptive information. [Source: 

http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystemUniqueIngredientIdentifierUNII/]

Note: If a UNII does not exist, please go to 

http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystemUniqueIngredientIdentifierUNII/

Text 1 UNIIs are not required 

for:

Human Cells, Tissues and 

Cellular and Tissue-Based 

Products (HCT/Ps) that 

are regulated solely 

under section 361 of the 

Public Health Service Act 

and 21 CFR part 1271.

Blood and blood 

components intended for 

transfusion (must be 

labeled consistent with 

the requirements in 21 

CFR 606.121 (container 

label) and 606.122
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# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardin

ality

Business Rule

(BR)/Comments

(circular of 

information)), or labeling 

associated with licensed 

in vitro diagnostic (IVD), 

Blood Grouping Reagents

(BGR) products.

23 CAS Number Chemical Abstract Service (CAS) Registry Numbers (often referred to as CAS RNs 

or CAS Numbers) are used to provide unmistakable identifiers for chemical 

substances. A CAS Registry Number itself has no inherent chemical significance 

but provides a way to identify a chemical substance or molecular structure

when there are many possible systematic, generic, proprietary or trivial names. 

[Source: Adapted from CAS.org]

Example: CAS [103-90-2]

Text 0..1

24 Drug Substance 

Component 

Supplier Name 

The name of the entity that was the source for the component. It may be 

different from the manufacturer of the component. [Source: SME Defined]

Note: Supplier is synonymous to a Distributor

Text

0..1 BR: For raw materials, 

supplier information is 

not required, but if a 

supplier is identified then 

a supplier name must be 

provided.

25 Drug Substance 

Component 

Supplier 

Address

The complete address for the supplier. [Source: SME Defined] Text 0..1 BR: For raw materials, 

supplier information is 

not required, but if a 

supplier is identified then 

a supplier address must 

be provided.

26 Drug Substance 

Component 

Manufacturer 

Name

The name of the entity that created, made, produced, or fabricated the 

component. [Source: SME Defined ]

Text

0..* BR: For raw materials, 

manufacturer 

information is not 

required, but if a 

manufacturer is 

identified then a 

manufacturer name must 

be provided.
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# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardin

ality

Business Rule

(BR)/Comments

27 Drug Substance 

Component 

Manufacturer 

Address

The complete address for the manufacturer of the component. [Source: SME 

Defined]

Text

0..* BR: For raw materials, 

manufacturer 

information is not 

required, but if a 

manufacturer is 

identified then a 

manufacturer address 

must be provided.

28 Source Type A classification that provides the origin of the raw material. [Source: SME 

Defined]

Code 1 IF raw material source 

type equals

Microbial, Animal, Plant, 

Insect or Human

THEN the 4 source 

related attributes and 

the manufacturer and 

supplier information is 

“highly desirable” 

(optional from system 

point of view)

29 Source 

Organism

The name, genus or genus and species of the organism from which the material 

is derived. [Source: SME Defined] 

Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat 

or rattus.

Text 0..1

30 Source 

Organism Part

A fragment of the source organism. [Source: SME Defined]

Examples: secretions, material from a specific organ, tissue, or portion of the 

organism such as liver, pancreas, blood or from bark or seed of a plant.

IDMP 11238 definition & examples: Entity of anatomical origin of source 

material within an organism.

Cartilage, Root and Stolon, whole plant is considered as a part, Aerial part of 

the plant, Leaf, Tuberous Root, whole animal

Text 0..1
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# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardin

ality

Business Rule

(BR)/Comments

31 Source 

Organism 

Country of 

Origin 

The name of the country where the organism was reared. [Source: SME 

Defined]

Code 0..1

32 Drug Substance 

Impurity Name

Any component of the drug substance which is not the chemical entity defined 

as the drug substance. [Source: ICH Q6A]

Examples: CHO cell protein, QQ201234, Residual DNA, gentamicin.

Note: For example, this could also be a common name, systematic name or a 

company code

Text 1..*

33 UNII (of the 

Impurity)

The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, 

alphanumeric identifier based on a substance’s molecular structure and/or 

descriptive information. [Source: 

http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystemUniqueIngredientIdentifierUNII/]

Note: If a UNII does not exist, please go to 

http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystemUniqueIngredientIdentifierUNII/

Text 0..1 UNIIs are not required 

for:

Human Cells, Tissues and 

Cellular and Tissue-Based 

Products (HCT/Ps) that 

are regulated solely 

under section 361 of the 

Public Health Service Act 

and 21 CFR part 1271.

Blood and blood 

components intended for 

transfusion (must be 

labeled consistent with 

the requirements in 21 

CFR 606.121 (container 

label) and 606.122 

(circular of 

information)), or labeling 

associated with licensed 

in vitro diagnostic (IVD), 

Blood Grouping Reagents 

(BGR) products.
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# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardin

ality

Business Rule

(BR)/Comments

34 Impurity 

Classification

A categorization of impurities based on its origin. [Source: SME Defined]

Examples: Degradation Product, Inorganic, Process Related/Process, Product 

Related, Leachables.

Code 1..*

35 Impurity 

Chemical 

Structure Data 

File

A machine-readable representation of the structure of the chemical. [Source: 

SME Defined]

Examples: Structured Data File (SDF), MDL MOLFILE, IUPAC Chemical Identifier

(InChI) file.

Text/ 

Binary

0..1

36 Impurity 

Structure 

Graphic

A pictorial representation of the structure of the impurity. [Source: SME 

Defined]

Graphic 0..1

37 Drug Substance 

Impurity 

Method Type 

The technique used to elucidate the structure or characterization of the 

impurity. [Source: SME Defined]

Code/ 

Text

0..*

38 Impurity 

Analysis Graphic 

The pictorial representation of the data. [Source: SME Defined]

Examples: spectrum, chromatogram.

Note: Refer to the "Acceptable File Formats for use in eCTD" 

Graphic 0..*

39 Impurity 

Analytical 

Instrument Data 

File 

The transport format for data exchange. [Source: SME Defined] Text/ 

Binary

0..*

40 Impurity 

Analytical 

Instrument Data 

File Type

A format name or abbreviation that identifies a file structure. [Source: SME 

Defined]

Examples: JCAMP, AnIML.

Text 0..1 BR: Required if Impurity 

Analytical Instrument 

Data File is provided.
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FHIR Mapping

PQ/CMC Data Element Name FHIR Resource Element Name FHIR Data Type

Drug Substance SubstanceDefinition DomainResource

UNII identifier Identifier UNII codes

Impurity Classification 

(only used when SubstanceDefinition is a reference) classification 

CodeableConcept

Binding: PQ/CMC Impurity Classification 

Terminology

Quality Standard grade 

CodeableConcept

Binding: PQ/CMC Quality Benchmark 

Terminology

Drug Substance Component Manufacturer Name

Drug Substance Component Manufacturer Address manufacturer Reference (Organization)

Drug Substance Component Supplier Name 

Drug Substance Component Supplier Address supplier Reference (Organization)

Substance Characterization Technique technique

CodeableConcept

Binding: Nomenclature|| Characterization

Molecular Weight molecularWeight

amount

structure BackboneElement

representation BackboneElement

Drug Substance Impurity Method Type type 

CodeableConcept

 Text only

Structural Representation

Impurity Chemical Structure Data File

Impurity Analytical Instrument Data File 

representation String 

Structural RepresentationType

Analytical Instrument Data File Type format 

CodeableConcept

Binding (Chemical Structure Data File 

Type): PQ/CMC Chemical Structure Data 

File Type Terminology

Substance Structure Graphic

Analysis Graphic 

Analytical Instrument Data File

Impurity Structure Graphic

document 

Reference (DocumentReference) 

Note: The file content is stored in the data 

element as Base64.
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Impurity Analysis Graphic

code BackboneElement

CAS Number

INN

USAN

IUPAC Name

ISBT 128

code 

CodeableConcept

Text only

name BackboneElement

Substance Name 

Drug Substance Impurity Name

Polymorphic Form Identification

Substance Component Name

Product Component Name

name string

A link between this substance and another, with details of the 

relationship relationship BackboneElement

A pointer to another substance, as a resource or just a 

representational code substanceDefinition[x] 

(Impurity Classification)

substanceDefinitionReference Reference (SubstanceDefinition)

Code (SubstanceDefinition Type)

Note: IG code system type 

CodeableConcept

Binding: IG codes

sourceMaterial BackboneElement

Source Type type 

CodeableConcept

Binding: PQ/CMC Source Type Terminology

Source Organism genus 

CodeableConcept

Text only

Source Organism species 

CodeableConcept

Text only

Source Organism Part part 

CodeableConcept

Text only

Source Organism Country of Origin countryOfOrigin 

CodeableConcept

Binding: Geopolitical Entities, Names, and 

Codes Terminology

END OF SECTION 1
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

17

Section 2: Drug Product Data Elements and FHIR Mapping

This section covers the properties of drug product component & composition; control of excipients and impurities. This information is 

typically submitted in eCTD sections -- 3.2.P.1; 3.2.P.4.1; 3.2.P.5.5.

Refer to Appendix A for several detailed examples that illustrate how to provide the strength of the ingredient using the PQ/CMC strengthrelated data elements. 

PQ/CMC Data Elements

# PQ/CMC Data 

Element Name

Data Element Name Definition Data Type Cardin

ality

Business Rule 

(BR)/Comments

1 Product 

Proprietary 

Name

The exclusive name of a drug product owned by a company under trademark 

law regardless of registration status with the Patent and Trademark Office

(PTO). [Source: 

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionR

equirements/ElectronicSubmissions/DataStandardsManualmonographs/ucm0

71683.htm]

Note: Excludes dosage form, route of administration and strength.

Example: Tylenol

Text 0..1

2 Product Nonproprietary 

Name

A name unprotected by trademark rights that is entirely in the public domain. 

It may be used without restriction by the public at large, both lay and 

professional. [Source: 

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionR

equirements/ElectronicSubmissions/DataStandardsManualmonographs/ucm0

71638.htm ]

Text 1

3 Co-Packaged 

Indicator

A property that identifies whether a drug product has been supplied along 

with an additional item, such as another drug product, a placebo, a diluent or 

an adjuvant. [Source: SME Defined]

Note: Any component that is dispensed separately or external to the drug 

Code 1
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

18

# PQ/CMC Data 

Element Name

Data Element Name Definition Data Type Cardin

ality

Business Rule 

(BR)/Comments

product is not considered co-packaged. Example -- Alka Seltzer. Since water is 

not supplied by the sponsor it is not considered as a co-packaged component. 

4 Dosage Form The form in which active and/or inert ingredient (s) are physically present. 

[Source: NCI EVS - C42636]

Examples: tablet, capsule, solution, cream that contains a drug substance 

generally, but not necessarily, in association with excipients. [Source: ICH Q1A

(R2)]

Note: If there is a new dosage form that does not exist in the controlled 

terminology, then propose this new dosage form during sponsor meetings 

with FDA.

Code 1

5 Route of 

Administration

Designation of the part of the body through which or into which, or the way in 

which, the medicinal product is intended to be introduced. In some cases, a 

medicinal product can be intended for more than one route and/or method of 

administration. [Source: NCI EVS C38114]

Code 1

6 Strength Type A physical (content) or activity measurement of the strength of the ingredient.

[Source: SME Defined]

Example: Mass, Activity

Code 1 When Strength Type 

=Activity - IF UOM is 

UCUM Arbitrary Unit 

[arb'U], need to describe 

the Units in Strength 

Text data element

IF Strength Type = Mass 

THEN Strength Numeric 

and Strength UOM are 

Mandatory 

IF Strength Type = 

Activity THEN Strength 

Textual, Strength UOM

([arb'U]) and Strength 

Operator are applicable 

data elements. Strength 

Textual and Strength 
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

19

# PQ/CMC Data 

Element Name

Data Element Name Definition Data Type Cardin

ality

Business Rule 

(BR)/Comments

UOM will be Mandatory 

and Operator will be 

Optional

7 StrengthNumer

icNumerator

The content of an ingredient expressed quantitatively per dosage unit, per 

unit of volume, or per unit of weight, according to the pharmaceutical dosage 

form. This should be the strength as listed on the label. [Source: Adapted from 

NCI EVS C53294]

Note: Strength can also be referred to as potency in biologics and other 

products. This information may be captured on the label.

Number 0..1

8 StrengthNumer

icNumerator 

UOM

The labeled unit of measure for the content of an ingredient, expressed 

quantitatively per dosage unit. [Source: Adapted for NCI EVS C117055]

Code 0..1 BR: Required if 

StrengthNumericNumer

ator is provided.

9 StrengthNumer

icDenominator

Specifies the quantity of the ingredient (s) consistent with a single unit dose or 

as expressed on the label. [Source: SME Defined]

Note: Kg value is only applicable for veterinary applications. 

Note: This is the denominator value when expressing the strength for APIs

Example: 5 mg per 100 mL

Code 0..1

10 StrengthNumer

icDenominator 

UOM

The labeled unit of measure for the content of an ingredient, expressed 

quantitatively per dosage unit. [Source: Adapted for NCI EVS C117055]

Code 0..1 BR: Required if 

StrengthNumericDenom

inator is provided.

11 Strength 

Textual

A written description of the strength of the ingredient. [Source: SME Defined]

Note: This is typically applicable to biologics

Example: International Units for Enzymes

Text 0..1 BR: If the UOM is UCUM 

Arbitrary Unit [arb'U], 

you need to describe 

the units in the Strength 

Text data element.

12 Strength 

Operator

A mathematical symbol that denotes equality or inequality between two 

values. [Source: SME Defined] Examples: LT, EQ, NMT.

Note: This is typically applicable to biologics

Code 0..1 BR: See Strength Type 

BR
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

20

# PQ/CMC Data 

Element Name

Data Element Name Definition Data Type Cardin

ality

Business Rule 

(BR)/Comments

13 Drug Product 

Description

A textual narrative describing the drug product or products. [Source: SME 

Defined]

Examples: dosage form, container closure system, purpose.

Text 1..*

14 Container 

Closure System 

Description 

Any textual comments that describe the sum of container closure system (CCS) 

components that together contain and protect the dosage form or drug 

substance. [Source: Adapted from Q1A (R2)-ICH Glossary]

Example: White opaque, round 50 mL HDPE bottle with a fitted 33 mm child 

resistant black polypropylene threaded cap closure, aluminum sealed, and 

containing molecular sieve canister 2 gm (CAN TRISORB 2G) as desiccant.

Note: This includes primary packaging components and secondary packaging 

components, if the latter are intended to provide additional protection to the 

drug substance or the drug product. A packaging system is equivalent to a 

container closure system. [Source: Adapted from Q1A (R2)-ICH Glossary]

Text 1

15 Container Type The kind of container that drug substances and finished dosage forms are 

contained in, which could include both the immediate (or primary) and 

secondary containers [Source: Adapted from NCI Thesaurus C43164]

Code 1

16 Closure Type The kind of closures used for the container in which the drug substances and 

finished dosage forms are stored. [Source: SME Defined]

Code 1

17 Product 

Component 

Name

Any ingredient intended for use in the manufacture of a drug product, 

including those that may not appear in such drug product. [Source: (21 CFR 

210.3 (b) (3)) PAC-ATLS 1998]

Text 1

18 UNII The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, 

alphanumeric identifier based on a substance’s molecular structure and/or 

descriptive information. [Source: 

http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem

-UniqueIngredientIdentifierUNII/]

Note: If a UNII does not exist, please contact fda-srs@fda.hhs.gov

Text 1 UNIIs are not required 

for:

Human Cells, Tissues 

and Cellular and TissueBased Products (HCT/Ps) 

that are regulated solely 

under section 361 of the 

Public Health Service 

Act and 21 CFR part 

1271.

Blood and blood 
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

21

# PQ/CMC Data 

Element Name

Data Element Name Definition Data Type Cardin

ality

Business Rule 

(BR)/Comments

components intended 

for transfusion (must be 

labeled consistent with 

the requirements in 21 

CFR 606.121 (container 

label) and 606.122

(circular of 

information)), or 

labeling associated with 

licensed in vitro 

diagnostic (IVD), Blood 

Grouping Reagents

(BGR) products.

19 Drug Product 

Component 

Function 

Category

A high-level classification that identifies the purpose of that material. [Source: 

SME Defined] 

Example: Active Ingredient, Inactive Ingredient, Adjuvant.

Code 1

20 Drug Product 

Component 

Function

A sub-classification of components identifying its purpose/role in the drug 

product. [Source: SME Defined]

Examples: Filler, Surfactant.

Code 1..* If Drug Product 

Component Function 

Category is Active 

Ingredient or Adjuvant 

THEN Drug Product 

Component Function 

will be NA

If Drug Product 

Component Function 

Category is Inactive 

Ingredient (excipient) 

THEN Drug Product 

Component Function 
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

22

# PQ/CMC Data 

Element Name

Data Element Name Definition Data Type Cardin

ality

Business Rule 

(BR)/Comments

must be from the value 

list.

21 Content (%) The percentage of the component in the drug product. [Source: SME Defined] Numerical 

Percent

0..1

22 Quality 

Standard

The established benchmark to which the component complies. [Source: SME 

Defined] 

Examples: USP/NF, EP, Company Standard

Code 1..*

23 Drug Product 

Component 

Additional 

Information

A placeholder for providing any comments that are relevant to the 

component. [Source: SME Defined]

Examples: removed during process, adjusted for loss on drying.

Text 0..*

24 Source Type A classification that provides the origin of the raw material. [Source: SME 

Defined]

Example: cat hair would be an Animal source type

Code

1

25 Source 

Organism

The name, genus or genus and species of the organism from which the 

material is derived. [Source: SME Defined] 

Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat 

or rattus.

Text

0..1

26 Source 

Organism Part

A fragment of the source organism. [Source: SME Defined]

Examples: secretions, material from a specific organ, tissue or portion of the 

organism such as liver, pancreas, blood or from bark or seed of a plant.

IDMP 11238 definition & examples: Entity of anatomical origin of source 

material within an organism.

Cartilage, Root and Stolon, whole plant is considered as a part, Aerial part of 

the plant, Leaf, Tuberous Root, whole animal

Text

0..1

27 Source 

Organism 

Country of 

Origin 

The name of the country where the organism was reared. [Source: SME 

Defined]

Code

0..1
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

23

# PQ/CMC Data 

Element Name

Data Element Name Definition Data Type Cardin

ality

Business Rule 

(BR)/Comments

28 Drug Product 

Impurity Name

Any component of the drug product which is not the chemical entity defined 

as the drug substance or an excipient in the drug product. [Source: ICH Q6A]

Examples: QQ201234, Residual DNA, Aggregates & degradants.

Note: For example, this could also be a common name, systematic name or a 

company code

Text 1..*

29 UNII The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, 

alphanumeric identifier based on a substance’s molecular structure and/or 

descriptive information. [Source: 

http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem

-UniqueIngredientIdentifierUNII/]

Note: If a UNII does not exist, please go to 

http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem

-UniqueIngredientIdentifierUNII/

Text 0..1 UNIIs are not required 

for:

Human Cells, Tissues 

and Cellular and TissueBased Products (HCT/Ps) 

that are regulated solely 

under section 361 of the 

Public Health Service 

Act and 21 CFR part 

1271.

Blood and blood 

components intended 

for transfusion (must be 

labeled consistent with 

the requirements in 21 

CFR 606.121 (container 

label) and 606.122 

(circular of 

information)), or 

labeling associated with 

licensed in vitro 

diagnostic (IVD), Blood 

Grouping Reagents 

(BGR) products.

30 CAS Number Chemical Abstract Service (CAS) Registry Numbers (often referred to as CAS 

RNs or CAS Numbers) are used to provide unmistakable identifiers for 

chemical substances. A CAS Registry Number itself has no inherent chemical 

significance but provides a way to identify a chemical substance or molecular 

Text 0..1
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

24

# PQ/CMC Data 

Element Name

Data Element Name Definition Data Type Cardin

ality

Business Rule 

(BR)/Comments

structure when there are many possible systematic, generic, proprietary or 

trivial names. [Source: Adapted from CAS.org]

Example: CAS [103-90-2]

31 Impurity 

Classification

A categorization of impurities based on its origin. [Source: SME Defined]

Examples: Degradation Product, Inorganic, Process Related/Process, Product 

Related, Leachables.

Code 1..*

32 Chemical 

Structure Data 

File

A machine-readable representation of the structure of the chemical. [Source: 

SME Defined]

Examples: SDF, MOLFILE, InChI file, cdx.

Text/Binary 0..1

33 Impurity 

Structure 

Graphic

A pictorial representation of the structure of the impurity. [Source: SME 

Defined]

Graphic 0..1

34 Drug Product 

Impurity 

Method Type 

The technique used to elucidate the structure or characterize the impurity. 

[Source: SME Defined]

Examples: NMR, Mass Spectrometry.

Text 0..*

35 Analysis 

Graphic 

The pictorial representation of the data. [Source: SME Defined]

Examples: spectrum, chromatogram.

Note: Refer to the "Acceptable File Formats for use in eCTD" 

Graphic 0..*

36 Analytical 

Instrument 

Data File 

The transport format for data exchange. [Source: SME Defined] Text/Binary 0..*

37 Analytical 

Instrument 

Data File Type

A value that identifies the file format. [Source: SME Defined]

Examples: JCAMP, AnIML.

Text 0..1 BR: Required if 

Analytical Instrument 

Data File is provided.
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

25

FHIR Mapping

PQ/CMC Data Element Name FHIR Resource Element Name FHIR Data Type

Drug Product MedicinalProductDefinition DomainResource

identifier Identifier

Drug Product Description description Markdown

Dosage Form combinedPharmaceuticalDoseForm 

CodeableConcept

Binding: SPL Pharmaceutical Dosage Form 

Terminology

Reference to Product Component ingredient CodeableReference (Ingredient)

Reference to ProductImpurity impurity Reference (SubstanceDefinition)

name BackboneElement

Product Proprietary Name

WHERE MedicinalProductDefinition.Name.type = "proprietary"

Product Non-proprietary Name

WHERE MedicinalProductDefinition.Name.type = "non-proprietary"

productName String

type 

CodeableConcept

Binding: IG codes

crossReference BackboneElement

Co-Packaged cross reference product 

CodeableReference

(MedicinalProductDefinition)

package BackboneElement

Reference to PackagedProductDefinition package Reference (PackagedProductDefinition)

administrableProduct BackboneElement

Route of Administration route 

CodeableConcept

Binding: SPL Pharmaceutical Dosage Form 

Terminology

Product Component Ingredient DomainResource
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

26

Reference Link identifier Identifier

Drug Product Component Function Category role

CodeableConcept

Binding: PQ/CMC Drug Product Component 

Function Category Terminology

Drug Product Component Function function

CodeableConcept

Binding: PQ/CMC Excipient Function 

Terminology

Component Group group

CodeableConcept

Binding: IG codes

Drug Product Component Additional Information description Markdown

substance BackboneElement

Reference to Ingredient Substance Definition code CodeableReference (SubstanceDefinition)

strength BackboneElement

extension:pqStrengthType

Strength Type (for API) value[x] string

extension:pqContentPercent

Content (%)

Note: same as %w/w 

value[x] Decimal

extension:pqStrenghtOperator

Strength Operator

Note: For use with presentationQuantity code

CodeableConcept

Binding: PQ/CMC Strength Operator 

Terminology

presentation[x]
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

27

StrengthNumericNumerator

Strength NumericNumerator UOM

StrengthNumericDenominator

StrengthNumericDenominatorUOM

presentationRatio Ratio

Strength (expressed with the Strength Operator) presentationQuantity Quantity

Strength Textual presentationText String

Ingredient Substance Definition SubstanceDefinition DomainResource

identifier Identifier

Quality Standard grade

CodeableConcept

Binding: PQ/CMC Quality Benchmark 

Terminology

code BackboneElement

UNII code

CodeableConcept

Binding: UNII codes

name BackboneElement

Product Component Name name string

type CodeableConcept

Binding: IG codes

Product Impurity Substance Definition SubstanceDefinition DomainResource

identifier Identifier
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

28

Impurity Classification classification

CodeableConcept

Binding: Process Related Product Related 

Contaminants

Binding: PQ/CMC Impurity Classification 

Terminology

code BackboneElement

UNII code CodeableConcept

Binding: UNII codes

structure BackboneElement

representation BackboneElement

Drug Substance Impurity Method Type type CodeableConcept

 Text only

Impurity Chemical Structure Data File

Impurity Analytical Instrument Data File representation 

String 

Impurity Structure Graphic

Impurity Analysis Graphic

document 

Reference (DocumentReference) 

Note: The file content is stored in the data 

element as Base64.

name BackboneElement

Drug Product Impurity Name name String

Drug Product Impurity Method Type type CodeableConcept

Binding: IG codes

Package PackagedProductDefinition PackagedProductDefinition DomainResource

identifier Identifier

Container Closure System Description description Markdown
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

29

Co-Packaged Indicator copackagedIndicator Boolean

package BackboneElement

Expiration Time

(If known) shelfLifeStorage ProductShelfLife

property BackboneElement

Container Type type

CodeableConcept

Binding: PQ/CMC Container Type 

Terminology

property BackboneElement

Closure Type type CodeableConcept

Binding: PQ/CMC Closure Type Terminology

containedItem BackboneElement

amount[x]

amountQuantity Quantity

END OF SECTION 2
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

30

Section 3: Batch Formula Data Elements and FHIR Mapping

This section covers the properties of batch formula for a drug product. This information is typically submitted in eCTD sections -- 3.2.P.3.2

PQ/CMC Data Elements

# PQ/CMC Data 

Element Name

Data Element Name Definition Data Type Cardinality Business Rule 

(BR)/Comments

1 Quantity The amount of material in a specific batch size [Source: SME Defined]

Example: 1000 kg

Numeric 1

2 Quantity UOM A named quantity in terms of which other quantities are measured or 

specified, used as a standard measurement of like kinds. [Source: NCI 

EVS - C25709]

Code 1

3 Batch Formula 

Additional 

Information

A placeholder for providing any comments that are relevant to the 

batch formula. [Source: SME Defined]

Examples: Water for wet granulation -- removed during processing; 

adjusted for assay.

Text 0..*

4 Overage Percent Overage is the percent of a drug substance in excess of the label claim 

to compensate for the loss, such as manufacturing or other. [Source:

SME Defined]

Note: This is not for stability loss, and generally not permitted

Example: 3% overage of drug that has a label claim of 10mg of active

(API) - the formulation would have 10.3 mg. A batch formula for 100 

kg would contain 103 kg of API.

Numeric 

Percent

0..1

5 Overage Justification The rationale for use of excess drug substance during manufacturing of 

the drug product [Source: SME Defined]

Text 0..1

6 Component 

Quantity Per Batch

Specifies the amount of the component per batch size of the drug 

product. [Source: SME Defined]

Numeric 1

7 Quantity Percent The percentage of the component in the batch [Source: SME Defined] Numeric 1

8 Component 

Additional 

Information

A placeholder for providing any comments relevant to the component. 

[Source: SME Defined]

Examples: Water for wet granulation - removed during process; 

adjusted for loss on drying.

Text 0..*
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

31

# PQ/CMC Data 

Element Name

Data Element Name Definition Data Type Cardinality Business Rule 

(BR)/Comments

9 Product Proprietary 

Name

See details of this element in Drug Product section 2

10 Strength Textual See details of this element in Drug Product section 2

11 Quality Standard See details of this element in Drug Product section 2

FHIR Mapping

The Batch Formula FHIR mapping contains a reference to the Ingredient resource. It is subject to change after ballot reconciliation on the 

Ingredient resource.

PQ/CMC Data Element Name FHIR Resource Element Name FHIR Data Type

Batch Formula PlanDefinition MetadataResource

title String

(required) status

code 

FHIR codes

subject[x]

subjectCanonical Canonical (MedicinalProductDefinition )

Batch Formula Additional Information description markdown

goal BackboneElement

target

BackboneElement

detail[x]

Quantity

Quantity UOM detailQuantity Quantity

action BackboneElement
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

32

definition[x]

definitionCanonical Canonical (ActivityDefinition )

Referenced Activity Definition ActivityDefinition MetadataResource

Reference Link identifier Identifier

Component Additional Information description markdown

product[x]

productReference Reference (Ingredient)

Batch Formula Ingredient Ingredient DomainResource

Reference Link identifier Identifier

Additional Information description markdown

substance BackboneElement

extension:pqQuantityPerrcent

Quantity Percent

value[x] Decimal

extension:pqOveragePercent

Overage Percent value[x] Decimal

extension:pqOverageJustification

Overage Justification value[x] string

Reference to Ingredient Substance Definition code

CodeableReference (SubstanceDefinition

)

strength BackboneElement

concentration[x]
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

33

Component Quantity Per Batch concentrationQuantity Quantity

Ingredient Substance Definition SubstanceDefinition DomainResource

Reference Link identifier Identifier

code BackboneElement

UNII code

CodeableConcept

Binding: UNII codes

name BackboneElement

Product Component Name name string

END OF SECTION 3
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

34

Section 4: Quality Specification Data Elements and FHIR Mapping

This section covers the properties of a quality specification. This information is typically submitted in eCTD sections -- 3.2.S.4.1, 3.2.P.5.1.

Also used with Batch Information (3.2.S.4.4 and 3.2.P.5.4), Stability Data (3.2.S.7.3; 3.2.P.8.3) and Annual Report 1.13

NOTE: A quality specification is for a drug product or a drug substance, excipient, or raw material. This Quality Specification profile references 

the Drug Product or the Drug Substance Profile. Not all the data elements from the Drug Product and Drug Substance profiles are needed 

while building the Quality Specification Profile. The specific elements from the referenced profiles are identified in the FHIR Mapping table.

PQ/CMC Data Elements

# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardinality Business Rule 

(BR)/Comments

1 Specification Title The textual identification for the specification. [Source: SME 

Defined]

Example: <drug name> 75 mg chewable tablets

Note: This may include the name of the drug substance, product 

or the raw material/excipients. 

Text 1

2 Specification 

Subtitle 

An additional textual identification for the specification [Source: 

SME Defined]. 

Text 0..1 Some sponsors provide an 

additional title for the 

specification -- a subtitle. 

3 Specification Type A classification of specification related to the kind of the entity it is 

referencing. [Source: SME Defined]

Examples: Drug product, Drug substance.

Code 1

4 Specification 

Version

The alphanumeric text assigned by the sponsor to a particular 

edition of a specification. [Source: SME Defined]

Examples: 2.1, 13.2, ST1, 00001, 00002, <companyname>001.

Note: This value should be unique across all specifications for a 

given material, not just those with the same name

Text 1..* A Specification can have one 

or more versions.

5 Specification 

Version Date

The date when the sponsor assigned a date to a specific version. 

[Source: SME Defined]

Note: This is the date a particular version of the specification was 

internally accepted by the submitter.

Date 1
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

35

# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardinality Business Rule 

(BR)/Comments

6 Specification Status The current FDA regulatory status of the specification. [Source: 

SME Defined]

Examples: Approved, Not Approved, Reported in a CBE or AR.

Note: There are instances when FDA does approve the 

Specifications in a supplement or an amendment where other 

information in the dossier has not changed. 

Note: This is different from Application Status

Code 1

7 Specification Status 

Date

The date on which the FDA approval status for a specification 

became effective. [Source: SME Defined]

Note: If the application is not yet approved, then this is the date of 

the current submission OR the date of the complete response

(CR).

Note: This is not the application approval status date. 

Date 1

8 Specification 

Additional 

Information

Placeholder for providing any comments that are relevant to the 

specification. [Source: SME Defined]

Examples: replaces method ABC, using the XYZ facility.

Text 0..1

9 Test Name The textual description of a procedure or analytical method. 

[Source: SME Defined]

Examples: Assay by HPLC, moisture by Karl Fischer, analysis for 

impurities.

Note: as defined by the sponsor

Text 1

10 Test Method Origin A coded value specifying the source of the method. [Source: SME 

Defined]

Example: Compendial

Code 1

11 Test Category A high-level grouping of quality attributes for products, 

substances, raw materials, excipients, intermediates and reagents. 

[Source: SME Defined]. Examples: Assay, Biological Properties.

Code 1

12 Analytical Procedure The name of the technique used to determine the nature of a 

characteristic. [Source: SME Defined].

Note: The full descriptor of the technique is part of the next data 

element - Reference to Procedure

Text 1
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

36

# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardinality Business Rule 

(BR)/Comments

13 Reference to 

Procedure 

A sponsor/applicant provided alphanumeric code that identifies 

the procedure. [Source: SME Defined]. Example: HP1234-2008 

Note: This could also be a transferred lab method.

Text 1

14 Relative Retention 

Time 

The ratio of the retention time of a component relative to that of 

another used as a reference obtained under identical conditions as 

an alias for the name of the unidentified impurities. [Source: 

Adapted from USP] 

Example: 1:23 (a ratio)

Note: This is the title or name of the impurity (sometimes 

expressed as a ratio) and not the value.

Text 0..1

15 Test Additional 

Information

Placeholder for providing any comments that are relevant to the 

Test. [Source: SME Defined].

Text 0..*

16 Test Order The sequential number assigned to each Test to specify the order 

of display on the Quality Specification. [Source: SME Defined]

Numeric 1

17 Stage Name A textual description and/or a number that identifies a level within 

a sequential test. [Source: SME Defined]

Examples – Single Stage, Stage 1, Stage 2 (sometimes referred to 

as L1, L2 L3 or A1, A2 as in USP <711>)

Note: A Stage may or may not provide a conditional sequence with 

associated acceptance criteria. [Source: SME Defined] (e.g., 

dissolution test, pyrogen test - USP <151>; 21 CFR 610.13 (b) Test 

for pyrogenic substances)

Text 1

18 Stage Sequence 

Order

The order of the stages in regular succession. [Source: SME 

Defined]

Examples: 1, 2, 3.

Numeric 1

19 Stage Additional 

Information

Placeholder for providing any comments that are relevant to the 

Test. [Source: SME Defined] Text

0..*

20 Value The acceptable qualitative or text value of the result of the test. 

[Source: SME Defined]

Text 0..1

21 ValueNumeric The acceptable quantitative or numeric value for the result of the 

test. [Source: SME Defined]

Numeric 0..1
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

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# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardinality Business Rule 

(BR)/Comments

22 ValueNumeric UOM A named quantity in terms of which other quantities are measured 

or specified, used as a standard measurement of like kinds. 

[Source: NCI EVS - C25709]

Code 0..1 BR: Required if ValueNumeric 

is not null.

23 Original Text The text of the acceptance criteria as provided in the specification. 

[Source: SME Defined]

Examples: White to off-white cake; 22.5 - 27.5 mg/ml

Note: This is the text as it appears in the Specification.

Text 1

24 Acceptance Criteria 

Usage

A coded value specifying when a particular analytical procedure or 

measurement is being performed on a substance or a product. 

[Source: SME Defined]. 

Examples: Release, Stability.

Note: The concept of "In-Process" is subsumed by the Release 

code. 

Code 1..*

25 Interpretation Code A code that describes how to relate the given value to an 

acceptance value. [Source: SME Defined]

Note: When result value is numeric there is a controlled 

vocabulary; when result value is textual the vocabulary is 

Pass/Fail.

Code 1

26 Acceptance Criteria 

Additional 

Information

A textual field to provide any additional information about the 

acceptance criteria. [Source: SME Defined]

Example: value changed from 4% to 5% on 01/01/2010

Text 0..*
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

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FHIR Mapping

PQ/CMC Data Element Name FHIR Resource Element Name FHIR Data Type

Quality Specification

PlanDefinition 

MetadataResource

extension:pqSpecificationStatus

Specification Status code

CodeableConcept

Binding: PQ/CMC Specification Status 

Terminology

extension:pqSpecificationType

Specification Type code

CodeableConcept

Binding: PQ/CMC Specification Type 

Terminology

identifier 

Identifier

Specification Version

version 

string

Specification Title

title 

string

Subtitle (optional)

subtitle 

string

FHIR PublicationStatus (Required)

status 

code draft | active | retired | unknown

subject[x] 

subjectCanonical

canonical (MedicinalProductDefinition | 

SubstanceDefinition |)

Specification Status Date

date 

dateTime

goal 

BackboneElement

Acceptance Criteria Usage

category 

CodeableConcept

Binding: PQ/CMC Test Usage 

Terminology

Original Text

description 

CodeableConcept

Text only

documentation

RelatedArtifact
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

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type

code 

Fixed: documentation

Acceptance Criteria Additional Information

display

string

target 

BackboneElement

detail[x] 

Acceptance Criteria (Numeric) 

detailQuantity

Quantity

extension:pqInterpretationCode

valueCodeableConcept

CodeableConcept

Binding: PQ/CMC Interpretation Code

(numeric) Terminology

Acceptance Criteria (Numeric range) 

detailRange

Range

extension:pqInterpretationCode

valueCodeableConcept

CodeableConcept

Binding: PQ/CMC Interpretation Code

(numeric) Terminology

Acceptance Criteria (Text)

detailCodeableConcept

CodeableConcept

Binding: PQ/CMC Interpretation Code

(text) Terminology

action 

BackboneElement

extension:pqTestMethodOrigin

Test Method Origin

code

CodeableConcept

Binding: PQ/CMC Test Method Origin 

Terminology

extension:pqRRT

Test Order

Stage Order value[x] Decimal

extension:pqTestOrder
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

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Relative Retention Time

value[x] string

Test Name

Stage Name title 

string

Test Additional Information

description 

string

Test Category

Analytical Procedure (as Text) code 

CodeableConcept

Reference to Acceptance Criteria

goalId 

id

Alternate Test or Prior Stage

relatedAction 

BackboneElement

 targetId 

id

relationship 

code

concurrent | after 

ActionRelationshipType (Required)

Required for alternate tests

selectionBehavior

code exactly-one

dynamicValue

BackboneElement

Reference to Procedure

path

string

Stage

action 

see action

QS type is Drug Product

Drug Product MedicinalProductDefinition DomainResource

Dosage Form combinedPharmaceuticalDoseForm 

CodeableConcept

Binding: SPL Pharmaceutical Dosage 

Form Terminology

name BackboneElement

Product Proprietary Name

WHERE MedicinalProductDefinition.Name.type = 

"proprietary"

Product Non-proprietary Name

WHERE MedicinalProductDefinition.Name.type = "nonproprietary"

productName String

type CodeableConcept
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Binding: IG codes

Product Component Ingredient DomainResource

Reference Link identifier Identifier

substance BackboneElement

Reference to Ingredient Substance Definition code CodeableReference (CodeableConcept)

CodeableReference

Element

UNII concept

CodeableConcept

Binding: UNII codes

strength BackboneElement

Strength Textual presentationText string

QS type is Drug Substance

Drug Substance SubstanceDefinition DomainResource

UNII identifier 

Identifier UNII codes

Note: Small molecule

code BackboneElement

ISBT 128 code 

CodeableConcept

Text only 

Note: Not small molecule

name BackboneElement

Substance Name 

name string

 QS type is Drug Excipient 

Reference to Drug Substance SubstanceDefinition DomainResource

UNII identifier Identifier UNII codes

Drug Substance Component Manufacturer Name

Drug Substance Component Manufacturer Address manufacturer Reference (Organization)
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

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Drug Substance Component Supplier Name 

Drug Substance Component Supplier Address supplier Reference (Organization)

code BackboneElement

ISBT 128

code 

CodeableConcept

Text only

name BackboneElement

Product Component Name name string

sourceMaterial BackboneElement

Source Type type 

CodeableConcept

Binding: PQ/CMC Source Type 

Terminology

Source Organism genus 

CodeableConcept

Text only

Source Organism species 

CodeableConcept

Text only

Source Organism Part part 

CodeableConcept

Text only

Source Organism Country of Origin countryOfOrigin 

CodeableConcept

Binding: Geopolitical Entities, Names, 

and Codes Terminology

END OF SECTION 4
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

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Section 5: Batch Analysis Data Elements and FHIR Mapping

This section covers the properties of a batch analysis. This information is typically submitted in eCTD sections -- 3.2.S.4.4 and 3.2.P.5.4. Also 

used with Stability Data (3.2.S.7.3; 3.2.P.8.3) and Annual Report 1.13

NOTE: A batch analysis is on a drug product or a drug substance for a given quality specification. This Batch Analysis profile references the 

Drug Product or the Drug Substance and the identifier and the version of the Quality Specification. Not all the data elements from the Drug 

Product and Dug Substance profiles are needed while building the Batch Analysis Profile. The specific elements from the referenced profiles 

are identified in the FHIR Mapping table.

PQ/CMC Data Elements

# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardinality Business Rule (BR)/Comments

1 Batch or Lot 

Number (Bulk 

Batch ID)

A combination of letters, numbers, or symbols, or any 

combination of them, from which the complete history 

of the manufacture, processing, packing, holding, and 

distribution of a batch or lot of drug product or other 

material can be determined. [Source: Adapted reference: 

21 CFR 210.3 Definitions (4/1/2014)]

Text 1

2 Batch Size The batch size can be defined either by a fixed quantity 

or by the amount produced in a fixed time interval. 

[Source: ICH Q7 - Part of the definition of Batch]

Numeric 1

3 Batch Size Unit A named quantity in terms of which other quantities are 

measured or specified, used as a standard measurement 

of like kinds. [Source: NCI EVS - C25709]

Code 1

4 Retest Date The date after which samples of the drug substance 

should be examined to ensure compliance with the 

specification and thus suitable for use in the 

manufacture of a given drug product [Source: Adapted 

from Q1A (R2)]

Date 0..1 BR: For Substances and some biologics. 

Does not apply to Products and therefore 

optional.

5 Retest Date 

Classification

The endorsement of the Retest date that clarifies 

whether this date has been approved by the FDA or is 

Code 1 This classification applies to ALL 

substances. 
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# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardinality Business Rule (BR)/Comments

being proposed by the sponsor/applicant for a drug 

substance. [Source: SME Defined]

* For an original MF/application, Retest 

Date Classification is "Proposed".

* After an MF/application has been 

approved, Retest Date Classification is 

"Approved". 

* For a Supplement that’s changing the 

Retest Date that is already classified as 

"Approved" for the drug product or drug 

substance, the changed Retest Date 

Classification would be "Proposed".

*For substances that do not have a Retest 

Date, the Retest Date Classification will 

be "NA".

“Approved” applies to product AND 

“Adequate” applies to substances.

6 Manufacturing 

Date

The date associated with manufacturing a batch. 

[Source: SME Defined]

Note: See Manufacturing Date Description element.

Date 1

7 Manufacturing 

Date Description

A textual description that provides a rationale for the 

selection of the manufacturing date. [Source: SME 

Defined]

Note: This description should include the specific 

operation/step in the manufacturing process associated 

with the assigned manufacturing date, for example fill 

step or filtration step.

Text 1

8 Manufacturing 

Site Name

The name of the establishment (facilities) which 

manufacture, prepare, propagate, compound, process or 

package drugs that are commercially distributed in the 

U.S. or offered for import to the U.S. [Source: Adapted 

from FDA Drug Establishment Current Registration Site]

Text 1..*

9 Manufacturing 

Site Unique 

A unique identifier assigned to the establishment 

(facility) which manufactures, prepares, propagates, 

Text 1..*
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# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardinality Business Rule (BR)/Comments

Identifier compounds or processes drugs. [Source: Adapted from 

FDA Drug Establishment Current Registration Site]

10 Manufacturing 

Site Unique 

Identifier Type

A value that identifies the source of the unique 

identifier. [Source: SME Defined]

Examples: Data Universal Number System (DUNS), Facility 

Establishment Identifiers (FEI), etc.

Code 1 BR: For every Manufacturing Site Unique 

Identifier there will only be one type.

11 Manufacturing 

Site Physical 

Address

The complete address for the supplier [Source: SME 

Defined]

Text 0..1

12 Expiration Date The date the manufacturer guarantees the full potency 

and safety of a particular batch/lot of medicinal product. 

The complete point in time date consisting of day, 

month and year shall be specified using the ISO 8601 

date format. [Source: ISO IDMP 11615-2017]

Date 0..1 BR: Required if the marketing application 

has been approved. Applies for Products. 

Also applies to some antibiotic 

substances. Expiration date would not 

apply when the FDA has not yet approved 

the marketing application. 

BR: When Batch Lot is Bulk, the expiration 

date is the Hold time.

13 Expiration Date 

Classification

The endorsement of the expiration date that clarifies 

whether this date has been approved by the FDA or is 

being proposed by the sponsor/applicant. [Source: SME 

Defined]

Code 1 This classification applies to all products 

and some substances.

* For an original application, Expiration 

Date Classification is "Proposed".

* After an application has been approved, 

Expiration date classification is 

"Approved". 

* For a Supplement that’s changing the 

expiration date that is already classified 

as "Approved" for the drug product or 

drug substance, the changed Expiration 

Date Classification would be "Proposed".

* For substances that do not have an 

Expiration Date, the Expiration Date 

Classification is "NA".
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

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# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardinality Business Rule (BR)/Comments

“Approved” applies to product AND 

“Adequate” applies to substances.

14 Batch Utilization A categorization of the batch that identifies its usage. 

[Source: SME Defined]

Examples: commercial, development.

Code 1..*

15 Batch Analysis 

Release Date

The date at which the drug substance or drug product is 

released by the quality assurance unit of the 

sponsor/applicant. [Source: SME Defined]

Note: A single release date per batch.

Date 0..1

16 Drug Substance 

Lot Number

Lot number of the drug substance used in manufacturing 

a drug product batch. [Source: SME Defined]

Text 1..*

17 Container Lot 

Number

A combination of letters, numbers, or symbols, or any 

combination of them to uniquely identify the container's 

manufacturing lot.

Note: This is different from the drug product batch/lot 

number. 

Example: Company A makes batch of bottles (container) 

-- need a lot number on the container (bottle) assigned 

by the manufacturer of the bottle (container). This 

requirement becomes critical when the dosing and 

delivery of the drug is impacted by the container 

(bottle).

Text 0..1 BR: When container is critical to dosing 

and delivery, the container lot number 

would be mandatory. Example, when the 

container is a nebulizer.

18 Container Closure 

System 

Description

Any textual comments that describe the sum of 

container closure system (CCS) components that 

together contain and protect the dosage form or drug 

substance. [Source: Adapted from Q1A (R2)-ICH 

Glossary]

Example: White opaque, round 50 mL HDPE bottle with a 

fitted 33 mm child resistant black polypropylene 

threaded cap closure, aluminum sealed, and containing 

molecular sieve canister 2 gm (CAN TRISORB 2G) as 

desiccant.

Text 1
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

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# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardinality Business Rule (BR)/Comments

Note: This includes primary packaging components and 

secondary packaging components, if the latter are intended 

to provide additional protection to the drug substance or 

the drug product. A packaging system is equivalent to a 

container closure system. [Source: Adapted from Q1A 

(R2)-ICH Glossary]

19 Container Type The kind of container that drug substances and finished 

dosage forms are contained in, which could include both 

the immediate (or primary) and secondary containers 

[Source: Adapted from NCI Thesaurus C43164]

Code 1

20 Closure Type The kind of closures used for the container in which the 

drug substances and finished dosage forms are stored. 

[Source: SME Defined]

Code 1

21 Container Size The volume or physical proportions or dimension of the 

container. [Source: SME Defined] Example: 250 (mL)

Note: may not apply to all container types, for example –

single dose container sizes

Numeric 1

22 Container Size 

Unit

A named quantity in terms of which other quantities are 

measured or specified, used as a standard measurement 

of like kinds. [Source: NCI EVS - C25709]

Examples: mL, L, cc.

Code 1

23 Container Fill Amount or volume of the drug product in the container. 

[Source: SME Defined].

Examples: 100 tablets; 10 mL, 1 transdermal system, 1 

sachet.

Note: the examples include both the Container Fill and 

the Container Fill Unit

Numeric 1

24 Container Fill Unit A named quantity in terms of which other quantities are 

measured or specified, used as a standard measurement 

of like kinds. [Source: NCI EVS - C25709]

Examples: tablets, mL.

Code 1

25 Additional 

Information

A placeholder for providing any comments that are 

relevant to the Batch. [Source: SME Defined]

Examples: first batch manufactured at a new facility; first 

Text 0..*
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

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# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardinality Business Rule (BR)/Comments

batch manufactured using a new Active Pharmaceutical 

Ingredient (API) source, new process, new container 

closure.

26 Conformance to 

Criteria

A coded value specifying whether the results of a 

particular test on a given batch of a drug substance or a 

drug product comply with the acceptance criteria. 

[Source: SME Defined]

Examples: Conforms, Does not Conform

Code 1

27 Test Date The date when a particular test was performed. [Source: 

SME Defined]

Date 1

28 Result The outcome of a test performed on a batch. [Source: 

SME Defined]

Examples: 98% for Assay; 7.1 for pH.

Text

Numeric

1 BR: When result is quantitative, then 

numeric Results, Result Unit of Measure 

and Conformance to criteria data 

elements are "Mandatory".

When Result is qualitative, Results and 

Results Unit of Measure data elements 

are "Optional" and Conformance to 

criteria data element is "Mandatory"

29 Result Unit of 

Measure

A named quantity in terms of which other quantities are 

measured or specified, used as a standard measurement 

of like kinds. [Source: NCI EVS - C25709]

Code 0..1

30 Replicate Number An identification number for a member of the set of 

results for a test, usually the sequence order in which 

the test was executed. Individual test are executed on 

multiple samples to give greater validity to the findings. 

[Source: SME Defined]

Examples: Prepare six aliquots from the sample.

Test 8 samples. If any fall above 110%, test an additional 

7 samples. Record all replicate values as stated in the 

method.

Numeric 1

31 Testing Site 

Unique Identifier

A unique identifier assigned to the establishment (facility) 

which performs the testing. [Source: SME Defined]

Text 1..*
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

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# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardinality Business Rule (BR)/Comments

32 Testing Site 

Unique Identifier 

Type

A value that identifies the source of the unique 

identifier. [Source: SME Defined]

Examples: DUNS, FEI.

Code 1 BR - For every Testing Site Unique 

Identifier there will only be one type.

33 Testing Site Name The name of the establishment (facility) which tests the 

raw materials, intermediates, drug substance, drug 

product, packaging components. [Source: SME Defined]

Text 1

34 Testing Site 

Address

The complete address for the testing site. [Source: SME 

defined]

Text 1

35 Test Name See details of this element in Quality Specification 

section 4

36 Test Category See details of this element in Quality Specification 

section 4

37 Analytical 

Procedure

See details of this element in Quality Specification 

section 4

38 Relative 

Retention Time

See details of this element in Quality Specification 

section 4

39 Test Additional 

Information

See details of this element in Quality Specification 

section 4

40 Test Order See details of this element in Quality Specification

section 4

41 Stage Name See details of this element in Quality Specification

section 4

42 Stage Sequence 

Order

See details of this element in Quality Specification

section 4

43 Stage Additional 

Information

See details of this element in Quality Specification

section 4

44 Value See details of this element in Quality Specification

section 4
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

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# PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardinality Business Rule (BR)/Comments

45 ValueNumeric See details of this element in Quality Specification

section 4

46 ValueNumeric 

UOM

See details of this element in Quality Specification

section 4

47 Original Text See details of this element in Quality Specification

section 4

48 Acceptance 

Criteria Usage

See details of this element in Quality Specification

section 4

49 Interpretation 

Code

See details of this element in Quality Specification

section 4

50 Additional 

Information

See details of this element in Quality Specification

section 4

FHIR Mapping

PQ/CMC Data Element Name FHIR Resource Element Name FHIR Data Type

Batch Analysis

DiagnosticReport

DomainResource

Specification and Specification Version

pqQualitySpecification

Extension

identifier

Identifier

DiagnosticReportStatus

(Required) status

Code

Binding: FHIR

Name/Code for this diagnostic report

(Required) code

CodeableConcept

Binding: FHIR IG

subject

Reference(Medication | Substance)

Batch Analysis Release Date

effective[x]

effectiveDateTime

dateTime
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Test Site

performer

Reference(Organization)

Result

result

Reference(Observation)

Test Site Organization Organization

DomainResource

Testing Site Unique Identifier

identifier

Identifier

Testing Site Unique Identifier Type

type

CodeableConcept

Testing Site Name

name

String

Testing Site Address

address

Address

Result Observation Observation

DomainResource

Stage identifier

Identifier

Note: Fixed “Single Stage” for nonstaged test

status

code

Binding: FHIR codes

Test Category category

CodeableConcept

Test Name

RRT code

CodeableConcept

Text only

effective[x]

Test Date effectiveDateTime

dateTime

Reference (Testing Site Unique Identifier)

performer

Reference (Organization )

value[x]

Result

Result Unit of Measure valueQuantity

Quantity

Result

valueString

string

dataAbsentReason

CodeableConcept

Binding: FHIR codes

Conformance to Criteria interpretation

CodeableConcept
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Binding: Conformance to Criteria 

Terminology

Additional Information note

Annotation

Analytical Procedure method

CodeableConcept

Text only

referenceRange

BackboneElement

Note: Corresponds to Acceptance 

Criteria in Quality Specification

low

SimpleQuantity

Interpretation Code extension:pqInterpCode

value[x]

CodeableConcept

Binding: Interpretation Code (numeric) 

Terminology

high

SimpleQuantity

Interpretation Code extension:pqInterpCode

value[x]

CodeableConcept

Binding: Interpretation Code (numeric) 

Terminology

Original Text

text

string

Note: For non-numeric tests, the Original 

Text is the only required element for 

referenceRange.

hasMember

Reference (Observation )

Note: The Stage Sequence Order is 

implied from the hasMember element. 

The reference is to the next stage.

component

BackboneElement

extension:pqReplicate

Replicate Number value[x] Integer

Test Name

RRT code

CodeableConcept

Text Only

value[x]
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Result

Result Unit of Measure valueQuantity

Quantity

Result

valueString

string

dataAbsentReason

CodeableConcept

Binding: FHIR codes

Conformance to Criteria interpretation

CodeableConcept

Binding: Conformance to Criteria 

Terminology

referenceRange

see referenceRange

Reference (Medication) Medication DomainResource

Product Proprietary Name

Product Non-proprietary Name

identifier Identifier

Organization responsible for manufacturing the item

sponsor Reference(Organization)

Dosage Form doseForm CodeableConcept

Binding: SPL Pharmaceutical Dosage 

Form Terminology

Active or inactive ingredient ingredient

UNII

item

CodeableReference

Binding: UNII codes

Active ingredient indicator

isActive

boolean

Quantity of ingredient present strength[x]

strengthRatio

Ratio

Details about packaged medications batch BackboneElement

manufacturingBatch Extension: URL = 

http://hl7.org/fhir/StructureDefinition/m

edication-manufacturingBatch

extension:manufacturingDate Extension

url uri
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Manufacturing Date value[x] dateTime

extension:manufacturingDateClassificatio

n

Extension

url uri

Manufacturing Date Description value[x] CodeableConcept

Text only

Extension extension:assignedManufacturer Extension

url uri

Manufacturing Site value[x] Reference(Organization)

extension:expirationDateClassification

Extension

url uri

Expiration Date Classification value[x] CodeableConcept

Binding: Expiration Date Classification 

Terminology

extension:batchUtilization Extension

url uri

Batch Utilization value[x] CodeableConcept

Binding: PQ/CMC Batch Utilization 

Terminology

extension:batchQuantity Extension

url uri

Batch Size

Batch Size Unit value[x] Quantity

extension:additionalInformation Extension

url uri

Additional Information value[x] string
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extension:container Extension

extension:lotNumber Extension

url uri

Container Lot Number value[x] string

extension:type Extension

url uri

Container Type value[x] CodeableConcept

Binding: PQ/CMC Container Type 

Terminology

extension:quantity Extension

url uri

Container Fill

Container Fill Unit

Container Size

Container Size Unit

value[x] Ratio

extension:closureSystemDescription

Extension

url uri

Container Closure System Description value[x] string

extension:closureType Extension

url uri

Closure Type value[x] CodeableConcept

Binding: PQ/CMC Closure Type 

Terminology

Batch or Lot Number (Bulk Batch ID) lotNumber string

Expiration Date

expirationDate

dateTime

Reference (Substance) Substance

DomainResource
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

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manufacturingBatch Extension: URL = 

http://hl7.org/fhir/StructureDefinition/m

edication-manufacturingBatch

extension:manufacturingDate Extension

url

uri

Manufacturing Date

value[x]

dateTime

extension:manufacturingDateClassificatio

n

Extension

url

uri

Manufacturing Date Description

value[x]

CodeableConcept

Text only 

extension:assignedManufacturer Extension

url

uri

Manufacturing Site

value[x]

Reference (Organization)

extension:expirationDateClassification

Extension

url

uri

Retest Date Classification

value[x]

CodeableConcept

Binding: Expiration Date Classification

extension:batchUtilization Extension

url

uri

Batch Utilization

value[x]

CodeableConcept

Binding: PQ/CMC Batch Utilization 

Terminology
Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

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extension:batchQuantity Extension

url

uri

Batch Size

Batch Size Unit value[x]

Quantity

extension:additionalInformation Extension

url

uri

Additional Information

value[x]

string

extension:container Extension

extension:type Extension

url uri

Container Type value[x] CodeableConcept

Binding: PQ/CMC Container Type 

Terminology

extension:quantity Extension

url uri

Container Fill

Container Fill Unit

Container Size

Container Size Unit

value[x] Ratio

extension:closureSystemDescription

Extension

url uri

Container Closure System Description value[x] string

extension:closureType Extension

url uri

Closure Type value[x] CodeableConcept

Binding: PQ/CMC Closure Type 
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Terminology

Batch or Lot Number (Bulk Batch ID) identifier

Identifier

instance

boolean

Fixed:”true”

status

code

active | inactive

UNII

Company Code

CAS Number

Substance Name

code

CodeableReference

Binding: UNII codes; Others optional

Note: Substance Name text

Retest Date expiry

dateTime

END OF SECTION 5
50

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

Section 6: Stability Data Elements and FHIR Mapping

This section covers the properties of a stability study. This information is typically submitted in eCTD sections -- 3.2.S.7.3, 3.2.P.8.3. 

NOTE: A Stability study is on a drug product or a drug substance for compliance with a given quality specification. This Stability Study profile 

references the Drug Product or the Drug Substance and includes some referential elements from Batch Analysis and Quality Specification. Not 

all the data elements from the Drug Product and Dug Substance profiles are needed while building the Stability Study Profile. The specific 

elements from the referenced profiles are identified in the FHIR Mapping table.

The main study is the collection and has its stated study purpose for the collection. The Sub-study is used to designate the conditions for the 

samples. The Diagnostic Report resource collects all the observations for a study time point/pull date. A single file with the main study and all 

sub-studies can be entered within the contained FHIR element in the same file. Consideration of the file size must be noted. Anticipate the 

final data load. FHIR files are bound to the same maximum limit (100 MB) for the eCTD. A single sub-study can be submitted as a single file. 

The main study information is entered as a contained resource within the file. Complex study designs can be exchanged by using the part-of 

element in Research study to link research studies. A study can link to many studies. The relationship is one directional. The main study is not 

part-of any other study. The Sub-study always points to the prior condition of the sample. The main study has no condition. 

NOTE: In the Data Elements table for this section, the last column includes additional information besides the business rules. Since the 

business requirement exists to support both Primary (study) and Secondary (sub-study) studies, this FHIR Profile invokes the FHIR Research 

Study Resource twice to support that requirement. The last column of the table below indicates the support requirements for the two levels. 

“Both” indicates the element is required for both the primary/study and the secondary/sub-study. 

PQ/CMC Data Elements

#

PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardinality Business Rule (BR) /

Comments / Study 

1 Study Identifier An alphanumeric identifier assigned to a study as executed by the sponsoring 

organization. [Source: SME Defined]

Example: Study Number- 565758 

Text 1 Both

2 Study Name A non-unique textual identifier given to the drug stability study by the 

sponsoring organization. [Source: SME Defined]

Text 0..1 Both
50

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

#

PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardinality Business Rule (BR) /

Comments / Study 

Example: 00001 - Testing methotrexate as a pill tablet under the storage 

conditions of 25 deg C/65% RH.

3 Study Sub Title Additional name or title. [Source: SME Defined] Text 0..1

4 Study Design A textual description providing the details of the study plan which includes 

tests, time points, storage conditions, method. [Source: SME Defined]

Text 0..1 Study

5 Study Purpose A textual description intended to provide a high level objective and rationale 

for the study. [Source: SME Defined]

Example: The purpose of this study EX 2010PRD5758 is to confirm the 

stability of BellaVie TM (2 AMINOBUTYROLE ACID, DL) 2.0 mg, Pink Film 

Coated Extended Release Tablets (Product 54321) per the NDA post approval 

stability commitments.

Text 1 Study

6 Study Reason The rationale for submitting the stability data. [Source: SME Defined]

Examples: Annual Report, NDA, Pre-market approval.

Code 1..* Study

7 Study Start Date The date the product or substance is put into the stability chamber for a 

given set of storage conditions [Source: SME Defined]

Date 1 Both

8 Study End Date The date the study or sub-study completes or terminates. [Source: SME 

Defined]

Date 0..1 Both

9 Protocol 

Identifier

An alphanumeric identifier assigned to a prospective protocol plan by the 

sponsoring organization. [Source: SME Defined]

Note: A given Protocol can have multiple studies.

Text 0..1 Study

10 Protocol Version The alphanumeric text assigned by the sponsor to a particular edition of a 

stability study that is sequential. [Source: SME Defined]

Examples: 2.1, 2.2 or A1, A2 or P1, P2.

Text 0..1 Study

11 Sub Study Type A categorization of studies that identifies whether there are single or 

multiple phases of the study sometimes simulating the periods of use. 

[Source: SME Defined]

Examples: Standard, Cycled-simple.

Code 1 Sub-study

12 Storage 

Conditions 

Temp.RH

The temperature and the relative humidity under which the study was 

performed. [Source: SME Defined]

Code 0..1

1

Study

Sub-study

13 Study Additional A placeholder for providing comments about the stability study. [Source: 

SME Defined]

Text 0..1 Both
50

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

#

PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardinality Business Rule (BR) /

Comments / Study 

Comment

14 Container 

Orientation

The placement of a container during storage to understand the interactions 

between the product and the closure. [Source: SME Defined]

Examples: horizontal, upright.

Code 0..1 Sub-study

15 Quality 

Specification 

Identifier

See details of this element in Quality Specification section 4 Sub-study

16 Quality 

Specification 

Version

See details of this element in Quality Specification section 4 Sub-study

17 Pull Date The date when a particular sample of the batch lot was pulled from the 

stability chamber. [Source: SME Defined]

Date 1 Sub-study Results

BR: Mandatory when 

Batch Utilization = 

"Stability Study"

18 Interval Storage time of the batch in a climatic chamber. [Source: eStability 

Implementation Guide]

Numeric 1 Sub-study Results 

BR: Mandatory when 

Batch Utilization = 

"Stability Study"

19 Interval Unit The partitions of the study pause. [Source: eStability Implementation Guide] Code 1 Sub-study Results

BR: Mandatory when 

Batch Utilization = 

"Stability Study"

20 Interval

Description Code

This code describes any "delay" that happened during testing, e.g., none

(Immediate) or freeze sample (Delayed Frozen).

[Source: NCIt]

Code 1 Sub-study Results

BR: Mandatory when 

Batch Utilization = 

"Stability Study"

21 Reason Stopped The rationale for why the Stability study was terminated. [Source: SME 

Defined]

Text 0..1 Both
50

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

#

PQ/CMC Data 

Element Name

Data Element Name Definition Data 

Type

Cardinality Business Rule (BR) /

Comments / Study 
50

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

FHIR Mapping

PQ/CMC Data Element Name FHIR Resource Element Name FHIR Data Type

Stability Study ResearchStudy

DomainResource

Study Identifier

identifier

Identifier

Study Identifier (optional)

version

string

Study Name

title

string

protocol

Reference (PlanDefinition)

Identifier

extension:pqProtocolVersion

Protocol Version value[x]

string

Protocol Identifier

value

string

Study Reason

primaryPurposeType

CodeableConcept 

Binding: PQ/CMC Application Type 

Terminology

Study Design

description

markdown

Reason Stopped

whyStopped

CodeableConcept 

Text only

objective

BackboneElement

Study Purpose 

description

markdown

Stability Sub-study ResearchStudy

DomainResource

Sub-study Identifier

identifier

Identifier

Sub-study Identifier (optional) 

version

string

Sub-study Name 

title

string

Reference to main study or associated study

part of

Reference (ResearchStudy)

status

Code
50

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

PublicationStatus (Required) draft | active | retired | unknown

Storage Conditions Temp/RH

Container Orientation condition

CodeableConcept

Binding: PQ/CMC Storage Conditions 

Terminology

Binding: PQ/CMC Container Orientation 

Terminology

Sub-study Start Date

period

Period

Sub-study Storage Condition Comment

note

Annotation

Reason Stopped 

whyStopped

CodeableConcept 

Text only

objective

BackboneElement

Link to stability study results 

result

Reference (DiagnosticReport)

Stability Study Results

DiagnosticReport

DomainResource

pqPullInterval

Extension

Interval

value[x]

quantity

Interval Description Code

code

Code

Binding: Binding: PQ/CMC Time Point 

Description Terminology

pqQualitySpecification

Extension

Identifier 

Identifier

Quality Specification

value

string

Quality Specification Version

version

string

DiagnosticReportStatus

(Required) status

Code

Binding: FHIR

Name/Code for this diagnostic report

(Required) code

CodeableConcept

Binding: FHIR IG

subject

Reference (Medication | Substance)

Test Site

performer

Reference (Organization)
50

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

Result

result

Reference (Observation)

NOTE: Test Site Organization, Result Reference (Observation), Reference (Medication) Reference (Substance) are the 

same as those defined in the Batch Analysis profile in Section 5.

END OF SECTION 6
66

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

Section 7: Terminology

The table in section 7A and 7B contain the controlled terminology/vocabulary defined by FDA SMEs for a set of coded PQ/CMC

data elements. The controlled terminology table contains only those PQ/CMC data elements for which a value set has been

defined. The terminology table below has been alphabetically presented by the data element name.

• PQ/CMC Data Element Name: Denotes the name of the PQ/CMC element.

• NCIt Concept Codes: The unique identifier assigned to each concept by NCI EVS to permanently track a specific meaning.

• Valid Value: The allowable values for a given PQ/CMC data element.

• Valid Value Meaning: The description of the allowable value for the given PQ/CMC data element.

A: PQ/CMC Controlled Terminology

# PQ/CMC Data 

Element Name

Valid Values NCIt Concept 

Codes

Valid Value Meaning

1 Batch Utilization commercial C133990 A product batch intended for marketing.

development C133991 A batch produced during the characterization and process definition for the 

desired product.

clinical C133992 A batch produced for use in clinical trials.

validation C133993 A batch intended for use in verification and demonstration of suitability of the 

designed process. 

A collection and evaluation of data, from the process design stage through 

commercial production, which establishes scientific evidence that a process is 

capable of consistently delivering quality product. [Source: Process Validation 

Guidance --

http://www.fda.gov/downloads/Drugs/.../Guidances/UCM070336.pdf]

bioequivalence C133994 A batch produced and used for the purposes of determining bioequivalence of 

the product.

stability study C185328 A batch placed under study to determine the maintained performance 

parameters over time.
67

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

# PQ/CMC Data 

Element Name

Valid Values NCIt Concept 

Codes

Valid Value Meaning

2 Chemical 

Structure Data 

File Type

SMILES C54684 Simplified Molecular Input Line Entry System

SDF C133996 Structure Data File

MOLFILE C133910 MDL Molfile

InChI File (small 

molecule)

C54683 IUPAC Chemical Identifier

PDB C49039 Protein Data Bank

mmCIF (large 

molecules)

C133997 macromolecular Crystallographic Information Framework 

3 Closure Type NCIt Codes are 

available in 

section 7-B

4 Conformance to 

Criteria

Conforms C80262 The result complies with the acceptance criteria for the given test

Does not 

conform

C133998 The result does not comply with the acceptance criteria for the given test

5 Container 

Orientation

horizontal C25241 parallel to the surface

upright C86043 closure-up orientation

inverted C133999 closure down orientation

valve-up C133914 dispenser (valve) pointing upwards for inhalers
68

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

# PQ/CMC Data 

Element Name

Valid Values NCIt Concept 

Codes

Valid Value Meaning

valve- down C133915 dispenser (valve) pointing downwards for inhalers

6 Container Type NCIt Codes are 

available in 

section 7-B

7 Co-Packaged 

Indicator

Yes C49488 Yes

No C49487 No

8 Dosage Form See link in next 

column

http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/u

cm162038.htm

9 Drug Product 

Component 

Function 

Category

Active Ingredient C82533 Active ingredient – ingredient that has the pharmacological action. 

Adjuvant C2140 Adjuvant – an ingredient(s) which augments or promotes the pharmacological 

effect of the active ingredient(s) without itself being considered active

(typically used with vaccines).

Inactive 

Ingredient

C42637 Inactive ingredient, i.e., ingredients added for a purpose other than the 

intended pharmacological action. Inactive Ingredient is also referred to as 

excipient.
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Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

# PQ/CMC Data 

Element Name

Valid Values NCIt Concept 

Codes

Valid Value Meaning

10 Drug Product 

Component 

Function

NCIt Codes are 

available in 

section 7-B

11 Expiration Date 

Classification/Re

test Date 

Classification

Approved C185182 After an application has been approved, then the Expiration date classification 

is set to "Approved". Approved is only applicable to Drug Products.

Adequate C185186 The applicant has appropriate process understanding to demonstrate that the 

quality of the subsequent API can be satisfactorily controlled.

Proposed C185188 For a Supplement that’s changing the expiration date that is already classified 

as "Approved" for the drug product or drug substance, the changed expiration 

date classification would be "Proposed"

NA C48660 Not Applicable

12 Impurity 

Classification

Degradation 

Product

C176816 A molecule resulting from a chemical change brought about over time and/or 

by the action of something (e.g., light, temperature, pH, water, or by reaction 

with an excipient and/or the immediate container/closure system). [Source: 

SME Defined]

Examples: decomposition product, oxidation product, hydrolysis, etc.

Elemental 

Impurities

C185190 Elements that are found in the environment or that are used or introduced in 

the manufacture of drug substances or excipients. [Source: USP STIMULI 

Article, https://www.usp.org/sites/default/files/usp/document/ourwork/chemical-medicines/key-issues/elementalImpuritiesInformation.pdf]

Residual Solvent C176815 Inorganic or organic liquids remaining during the manufacturing process. 

[Source: Adapted from ICH Q3A(R2)]

Inorganic C134001 Materials that are not carbon-based and are generated during a manufacturing 

process that are not part of elemental impurity specification. [Source: SME 

Defined]
70

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

# PQ/CMC Data 

Element Name

Valid Values NCIt Concept 

Codes

Valid Value Meaning

Process 

Related/Process

C176812 Impurities that are derived from the manufacturing process. [Source: SME 

defined - Reviewed ICH - Q6A and Q3]

Examples: Small molecules -- starting materials, intermediates, antibiotics, or 

media components, by-products, etc.

Large molecules -- They may be derived from cell substrates (e.g., host cell 

proteins, host cell DNA), cell culture (e.g., inducers, antibiotics, or media 

components), or downstream processing (e.g., processing reagents or resin 

leachables).

Leachables C185192 Materials that can migrate from manufacturing systems, container-closure 

systems and drug-delivery components. [Source: Adapted from ICH Q3E 

Concept Paper]

Product Related C176813 Molecular variants of the desired product (e.g., precursors, certain 

degradation products arising during manufacture and/or storage) which do not 

have properties comparable to those of the desired product with respect to 

activity, efficacy, and safety. [Source ICH Q6B]

Microbiological C92081 Microorganism contamination of the cell culture or starting/raw materials that 

are objectionable due to their detrimental effect on products or potential 

harm to patients or due to the total number of organisms. [Source: 21CFR211 

Preamble]

Examples: bacteria, fungi, mollicutes (mycoplasmas or spiroplasmas), 

mycobacteria, rickettsia, protozoa, parasites, agents causing TSEs and viruses. 

[Source: Adapted from 21CFR211 Preamble]

13 Interpretation 

Code (numeric)

NMT (not more 

than) 

C61586 The value should not be greater than the given value and includes the given 

value, which is equivalent to “less than or equal to”. 

NLT (not less 

than)

C61583 The value should not be smaller than the given value and includes the given 

value, which is equivalent to “greater than or equal to”. 

MT (more than) C61584 The value should not be smaller than the given value excluding the given value, 

which is equivalent to “greater than”. 

LT (less than) C61585 The value should not be greater than the given value excluding the given value, 

which is equivalent to “less than”. 

EQ C48793 A person or thing equal to another in value or measure or force or effect or 

significance, etc.; being essentially equal to something.
71

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

# PQ/CMC Data 

Element Name

Valid Values NCIt Concept 

Codes

Valid Value Meaning

NA C48660 Not Applicable

14 Manufacturing 

Site Unique 

Identifier 

Type/Testing 

Site Unique 

Identifier Type

DUNS C134003 Data Universal Number System

FEI C134004 Facility Establishment Identifiers

CFN C134005 Central File Number

Unknown C17998 Unknown

15 Quality Standard USP/NF C134006 United States Pharmacopeia/National Formulary

EP C134007 European Pharmacopoeia 

JP C134008 Japanese Pharmacopoeia

BP C176793 British Pharmacopoeia

Company 

Standard

C134009 A proprietary standard internal to the organization.

Note: If pharmacopeia's other than the 4 listed are used, identify them as 

Company Standard. 

16 Route of 

Administration

See link in the 

next column

https://www.fda.gov/industry/structured-product-labeling-resources/routeadministration
72

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

# PQ/CMC Data 

Element Name

Valid Values NCIt Concept 

Codes

Valid Value Meaning

17 Source Organism 

country of origin

NCIt Codes are 

available in 

section 7-D

18 Source Type Chemical C48807 A substance with a defined atomic or molecular structure that results from, or 

takes part in, reactions involving changes in its structure, composition, or 

properties. [Source: NCI EVS C48807]

Animal C14182 A living organism that has membranous cell walls, requires oxygen and organic 

foods, and is capable of voluntary movement, as distinguished from a plant or 

mineral. [Source: NCI EVS C14182]

Microbial C14329 A microscopic organism. [Source: Adapted from NCI EVS C14329]

Plant C14258 Any living organism that typically synthesizes its food from inorganic 

substances, possesses cellulose cell walls, responds slowly and often 

permanently to a stimulus, lacks specialized sense organs and nervous system, 

and has no powers of locomotion. (EPA Terminology Reference System) 

[Source: NCI EVS C14258]

Insect C14227 A taxonomic class of arthropods that includes praying mantises, dragonflies, 

grasshoppers, true bugs, flies, bees, wasps, ants, butterflies, moths, and 

beetles. [Source: NCI EVS C14227]

Human C14225 The bipedal primate mammal, Homo sapiens; belonging to man or mankind; 

pertaining to man or to the race of man; use of man as experimental subject or 

unit of analysis in research. [Source: NCI EVS C14225]

Animal-derived 

indirectly

C18634 A material for which an earlier process step (or an ancillary process) in the 

manufacturing of the material whose input materials involved animal-derived 

materials. [Source: SME Defined]

– Example: Magnesium Stearate from animal source, BSA

19 Specification 

Status

Approved C25425 A specification that has met the requirements for approval

Note: Applies for NDA, NADA, ANDA, ANADA, BLA
73

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

# PQ/CMC Data 

Element Name

Valid Values NCIt Concept 

Codes

Valid Value Meaning

Tentatively 

Approved

C134010 A specification that met the requirements for approval, but the application 

could not be approved for reasons such as patents and exclusivity. 

Note: Applies for 351A BLA, 351K BLA, ANDA

Not Approved C134011 A specification that has not yet been approved.

Note: Applies for NDA, NADA, ANDA, ANADA, BLA

Reported in a 

CBE or AR

C134012 The specification may be used without prior approval and was submitted in a 

change being affected (CBE) supplement or an annual report (AR). 

Note: Applies for NDA, NADA, ANDA, ANADA, BLA

Not Applicable C48660 Determination of a value is not relevant in the current context. 

Note: Master files and INDs have the same information and are reviewed in 

the same way, but the FDA terminologies and the processing/encoding is 

slightly different. 

Applies for INDs, INAD, JINAD, MF

20 Specification 

Type

Drug Product C134021 The specification which is applied to the drug product.

Drug Substance C134022 The specification which is applied to the drug substance.

Raw Materials 

/Excipients/Inter

mediates/Reagen

ts

C133931 The specification which is applied to the raw materials, excipients, 

intermediates or reagents.

21 Storage 

Conditions

25 ± 2 0C /60% ± 

5% RH

C134014 Storage at 25 degrees Celsius plus or minus 2 degrees Celsius, along with 60 

percent relative humidity plus or minus 5 percent relative humidity. 

30 ± 2 0C /65% ± 

5% RH

C134015 Storage at 30 degrees Celsius plus or minus 2 degrees Celsius, along with 65 

percent relative humidity plus or minus 5 percent relative humidity. 

40 ± 2 0C /75% ± 

5% RH 

C134016 Storage at 40 degrees Celsius plus or minus 2 degrees Celsius, along with 75 

percent relative humidity plus or minus 5 percent relative humidity. 

5 ± 3 0C C133935 Storage at 5 degrees Celsius plus or minus 3 degrees Celsius. 
74

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

# PQ/CMC Data 

Element Name

Valid Values NCIt Concept 

Codes

Valid Value Meaning

-20 ± 50C C133936 Storage at minus 20 degrees Celsius plus or minus 5 degrees Celsius. 

Proprietary C96148 Storage conditions that are custom and unique to the product being tested

30 ± 2 0C /75% ± 

5% RH

C134017 Storage at 30 degrees Celsius plus or minus 2 degrees Celsius, along with 75 

percent relative humidity plus or minus 5 percent relative humidity. 

25 ± 2 0C /40% ± 

5% RH

C134018 Storage at 25 degrees Celsius plus or minus 2 degrees Celsius, along with 40 

percent relative humidity plus or minus 5 percent relative humidity. 

30 ± 2 °C/35% RH 

± 5% RH

C134019 Storage at 30 degrees Celsius plus or minus 2 degrees Celsius, along with 35 

percent relative humidity plus or minus 5 percent relative humidity. Note: Only 

for semi-permeable containers

40 ± 2 °C/not 

more than (NMT) 

25% RH

C133940 Storage at 40 degrees Celsius plus or minus 2 degrees Celsius, along with not 

more than 25 percent relative humidity. Note: Only for semi-permeable 

containers

22 Strength Type Mass C168628 A physical measurement (e.g., weight, genome titer)

Activity C45420 Measurement of a property related to therapeutic or biological effect. 

Examples, enzyme activity, international units, plaque forming units (PFU), 

radioactivity (MBql)

23 Strength 

Operator

NMT (not more 

than) 

C61586 The value should not be greater than the given value and includes the given 

value, which is equivalent to “less than or equal to”. 

NLT (not less 

than)

C61583 The value should not be smaller than the given value and includes the given 

value, which is equivalent to “greater than or equal to”. 

MT (more than) C61584 The value should not be smaller than the given value excluding the given value, 

which is equivalent to “greater than”. 

LT (less than) C61585 The value should not be greater than the given value excluding the given value, 

which is equivalent to “less than”. 

EQ C48793 A person or thing equal to another in value or measure or force or effect or 

significance etc.; being essentially equal to something.

NA C48660 Not Applicable
75

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

# PQ/CMC Data 

Element Name

Valid Values NCIt Concept 

Codes

Valid Value Meaning

24 Study Reason Abbreviated New 

Animal Drug 

Application

C115123 PQCMC data submitted to an abbreviated (generic) new animal drug 

application.

Abbreviated New 

Drug Application

C73113 PQCMC data submitted to an abbreviated (generic) new human drug 

application.

Biologics License 

Application

C71778 PQCMC data submitted to a biologics license application.

Generic 

Investigational 

New Animal Drug 

File

C115122 PQCMC data submitted to a generic investigational new animal drug file.

Humanitarian 

Device 

Exemption (HDE)

C80440 PQCMC data submitted for an HDE application.

Investigational 

Device 

Exemption

C82667 PQCMC data submitted to an investigational device exemption.

Investigational 

New Animal Drug 

File

C96091 PQCMC data submitted to an investigational new animal drug file.

Investigational 

New Drug 

Application

C96090 PQCMC data submitted to an investigational new human drug application.

New Active 

Ingredient

C96092 PQCMC data submitted for an active ingredient, could be PQCMC data for an 

active ingredient submitted in a drug application, or a Master File.

New Animal Drug 

Application

C72901 PQCMC data submitted to a new animal drug application.

New Drug 

Application

C72899 PQCMC data submitted to a new human drug application.

Premarket 

Approval

C70880 PQCMC data submitted for a PMA application.
76

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

# PQ/CMC Data 

Element Name

Valid Values NCIt Concept 

Codes

Valid Value Meaning

Premarket 

Notification 510

(K)

C80442 PQCMC data submitted for a premarket 510 (k) submission.

Master File C70877 to be added to NCI EVS

25 Study Type Standard C134026 A single set of environmental conditions. 

Example: 25 degree C, 60% RH.

Cycled-Simple C134027 A set of two alternating environmental conditions. 

Example: freeze-thaw cycled study.

Complex C134028 Multiple phases with different set of environmental conditions.

Note: It is standard study if there is only one storage condition. If there are 

multiple storage conditions, then this will be classified as Complex study. 

Transport Studies are considered Complex studies.

Examples: typically for inhalers, nebulizers; transportation studies.

Note: Complex studies MUST have associated studies

Photostability C96087 Studies that evaluate the light sensitivity and stability of drugs. [Refer to ICH 

Q1B]

26 Test Category Assay C60819 Tests which measure the content of the active ingredient in the drug 

substance or drug product. Synonymous with strength or purity which is 

commonly used of define the content of the active ingredient in a drug 

product. [Source: Adapted from ICH Q6A and Q6B] Note: chiral purity, 

preservative content, Anti-Oxidant Concentration, Chelate Concentration, 

isomeric ratio.

Biological 

Properties

C158425 Any effect a given material has on a living organism (e.g., microbial limits, 

endotoxin).

Description C138990 An assessment of the physical state (e.g., color, shape, size) of the drug 

substance or product. [Source: Adapted from ICH Q6A]

Identification C138993 Tests that establish the characteristic and uniqueness of the substance of 

interest and should be able to discriminate between compounds of closely 

related structures which are likely to be present. [Source: ICH Q6A]
77

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

# PQ/CMC Data 

Element Name

Valid Values NCIt Concept 

Codes

Valid Value Meaning

Impurities C158423 Analytical procedures that determine the presence of a component of the 

material that is not the chemical entity defined as the material.

Physico-Chemical 

Properties

C176811 Assessments of the characteristics of a material that are not associated with a 

change in its composition and basic nature, including but not limited to its 

texture, smell, freezing point, boiling point, melting point, opacity, viscosity 

and density.

A characteristic of a material that is observed during a reaction in which the 

chemical composition or identity of the material is changed (e.g., 

combustibility, solubility, acidity/basicity).

Microbiological 

Properties

C176810 The characteristics of, or the effects of a material on a microorganism or 

microbiome.

27 Test Method 

Origin

CFR C96164 Method defined in the Code of Federal Regulation (CFR)

Proprietary C96103 Method identified/defined by the sponsor/applicant (not recognized in CFR or 

any compendium)

Compendial C96102 Method defined in any recognized compendium (e.g., USP, EP, BP, JP). 

28 Test Usage Release C134029 For determination of acceptability for use of a material, drug or a drug 

substance.

NOTE: The "use" could be for distribution, marketing, further manufacturing 

stages.

Stability C134030 For determination of maintained performance parameters on storage over 

time, of a material, drug or a drug substance.

29 Testing Site 

Unique Identifier

DUNS C134003 Data Universal Number System

FEI C134004 Facility Establishment Identifiers
78

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

# PQ/CMC Data 

Element Name

Valid Values NCIt Concept 

Codes

Valid Value Meaning

CFN C134005 Central File Number

Unknown C17998 Unknown

30 Interval

Description Code

Delayed Testing C96151 Sample is not tested immediately.

Immediate 

Testing

C96150 Sample is tested immediately.

Ambient Delayed 

Testing

C96154 Sample is stored at ambient conditions and not tested immediately.

Frozen Delayed 

Testing

C96153 Sample is frozen and not tested immediately.

Refrigerated 

Delayed Testing

C96155 Sample is refrigerated and not tested immediately.

31 Unit of Measure: 

ValueNumeric

UOM; Batch Size 

Unit; Container 

Size Unit; 

Container Fill 

Unit; Strength 

Unit of Measure; 

Amount Per 

Unit; Diluent 

UOM; Amount 

UOM

Look at the NCIt 

Codes in section 

7-C
79

Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

B: Terminologies for Closure Type, Container Type, Component Function

# PQ/CMC Data 

Element Name

Valid Values NCIt Concept 

Codes

Valid Value Meaning

1 Closure Type Child-resistant, 

Metal

C96113 Metal closure that is designed or constructed to be significantly difficult for 

children under five years of age to open and not difficult for normal adults to 

use properly.

2 Closure Type Child-resistant, 

Plastic

C96114 Plastic closure that is designed or constructed to be significantly difficult for 

children under five years of age to open and not difficult for normal adults to 

use properly.

3 Closure Type Continuous 

Thread, Metal

C96115 Metal closure turned onto a corresponding thread on the top or mouth of a 

container, whether it be glass, plastic or metal.

4 Closure Type Continuous 

Thread, Plastic

C96116 Plastic closure turned onto a corresponding thread on the top or mouth of a 

container, whether it be glass, plastic or metal.

5 Closure Type Crown, Metal C96125 A non-threaded shallow draw metal closure that normally has 21 corrugations 

on the outer edge, which function to engage the container when applied. The 

crown is only 1/4" high when manufactured and does not have a rolled edge 

or wire. The crown is manufactured 26mm worldwide and can be applied to 

either a threaded finish or a solid ring pry-off finish.

6 Closure Type Flip-Top

(Dispensing), 

Plastic

C96128 A hinged single or dual flap closure for controlled product dispensing.

7 Closure Type Hinged

(Dispensing), 

Plastic

C96129 A closure with a lid that is hinged to the top of a closure and opens to expose a 

dispensing orifice.

8 Closure Type Linerless, Plastic C96130 A closure that incorporates a specific molded-in feature such as rings, plugs or 

flexible sections. These features achieve a seal by conforming to one or more 

of the sealing surfaces on the container neck finish.

9 Closure Type Lug, Metal C96126 Closure with an ability to be applied and removed with a partial turn. The 

closure can also be produced with vacuum buttons that can clearly indicate to 

the packer if a vacuum has been effectively drawn following the closure 

application.
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10 Closure Type Press-on, 

Composite

C96124 A metal/plastic composite cap composed of a plastisol lined metal disk, 

assembled to a plastic band. The closure requires a simple glass bead finish 

common on bowls, tumblers and carafes.

11 Closure Type Press-on/twistoff, MetalC96123 Closure with a stepped, skirted drawn shell with an inside curl. The closure is 

lined with an annular plastisol material designed to provide a proper seal along 

the top and side surfaces of the glass container finish. The closure uses a 

special plastisol material that, following application, takes a permanent 

impression of the glass threads ensuring cam-off and reseal.

12 Closure Type Pump

(Dispensing), 

Plastic

C96131 Closure dispensing pumps are used to dispense product from containers.

13 Closure Type Push-pull

(Dispensing), 

Plastic

C96132 A two-piece dispensing closure that includes a base member the lower portion 

of which is designed to attach and seal securely to a container finish and the 

upper portion of which is designed to receive a dispensing spout member. The 

spout member may be moved upward and downward to open and close the 

dispensing passageway.

14 Closure Type Roll-on, Metal C96127 A tamper-evident closure produced as an unthreaded shell containing a liner. 

It is applied to the proper finish on a plastic or glass container by the bottler, 

using a roll-on capping machine that forms a thread in the closure matching 

the bottle thread.

15 Closure Type Snap-on Cap, 

Plastic

C96133 A non-threaded closure that is pressed onto the package finish with a 

protruding feature that mates with a similar protruding feature on the closure 

to secure the closure to the package.

16 Closure Type Snip-tip

(Dispensing), 

Plastic

C96134 Conical closure that is turned onto a container. The tip is cut off to open the 

container.

17 Closure Type Stopper C96139 Object used to plug opening of container.

18 Closure Type Tamper-evident, 

Composite

C96120 Composite tamper-evident closures usually consist of a metal disk with a 

plastic skirt. The plastic skirt is perforated or weakened in some manner so 

that when the closure is removed, this section is designed to break and either 

remain on the container or attached to the closure to indicate the package has 

been opened.
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19 Closure Type Tamper-evident, 

Metal

C96117 A closure/finish of a closure/container system designed to make it difficult to 

achieve the first removal of a closure from a container without it being 

detectable by subsequent users that the package seal has been breached (e.g., 

aluminum overseal).

20 Closure Type Tamper-evident, 

Plastic

C96118 A closure that shows the package has been opened and the product has been 

exposed to the outside environment.

21 Closure Type Tie C96140 Line, ribbon, or cord used for fastening, or drawing the container closed.

22 Closure Type Toggle-swing

(Dispensing), 

Plastic

C96135 A closure with a lower part attaches securely and seals the container. The 

upper part provides a second movable portion which functions in a rocker-like

pivotal motion between an open and a closed position.

23 Closure Type Trigger Sprayer

(Dispensing), 

Plastic

C96136 Closure designed to dispense product from containers by spraying the product 

when a trigger is pulled.

24 Closure Type Twist Open/Close

(Dispensing), 

Plastic

C96137 Two-piece dispensing closure that has a lower portion designed to attach and 

seal securely to a container finish and the upper portion of which is designed 

to receive a dispensing spout member. Rotating the spout member opens and 

closed the container.

25 Closure Type Vacuum, 

Composite

C96122 Metal/Plastic closures used on packages where the pressure inside the 

package is less than atmospheric.

26 Closure Type Vacuum, Metal C96119 Metal closures used on packages where the pressure inside the package is less 

than atmospheric.

27 Closure Type Vacuum, Plastic C96121 Plastic closures used on packages where the pressure inside the package is less 

than atmospheric.

28 Closure Type Valved

(Dispensing), 

Plastic

C96138 Dispensing closure incorporating a product-flow controlling valve within the 

orifice. Product will not dispense from the package until sufficient squeezing 

pressure is applied to the flexible container to cause the valve to open.

29 Container Type AMPULE C43165 A container capable of being hermetically sealed, intended to hold sterile 

materials.

30 Container Type APPLICATOR C43166 A pre-filled non-injectable pipette, syringe or tube.

31 Container Type BAG C43167 A sac or pouch.

32 Container Type BLISTER PACK C43168 A package that consists of molded plastic or laminate that has indentations

(viewed as 'blisters' when flipped) into which a dosage form, is placed. A 
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covering, usually of laminated material, is then sealed to the molded part. A 

strip pack is a specialized type of blister pack where there are no pre-formed 

or molded parts; in this case there are two flexible layers that are sealed with 

the dosage form in between. Suppositories that are strip packed between two 

layers of foil are also considered a blister pack.

34 Container Type BOTTLE C43169 A vessel with a narrow neck designed to accept a specific closure.

35 Container Type BOTTLE, 

DISPENSING

C43170 A bottle that is used by the pharmacist to dispense the prescribed medication. 

It includes preparations for which a dropper accompanies the bottle.

36 Container Type BOTTLE, 

DROPPER

C43171 A bottle that has a device specifically intended for the application of a liquid in 

a drop by drop manner, or a device intended for the delivery of an exact dose

(e.g., calibrated dropper for oral medications).

37 Container Type BOTTLE, GLASS C43172 A glass vessel with a narrow neck designed to accept a specific closure.

38 Container Type BOTTLE, PLASTIC C43173 A plastic vessel with a narrow neck designed to accept a specific closure.

39 Container Type BOTTLE, PUMP C43174 A bottle that is fitted with a pumping mechanism for the administration of 

drug product.

40 Container Type BOTTLE, SPRAY C43175 A bottle that is fitted with an atomizer or a device which produces finely 

divided liquid carried by air.

41 Container Type BOTTLE, UNITDOSEC43176 A bottle that contains a single whole dose of a non-parenteral drug product.

42 Container Type BOTTLE, WITH 

APPLICATOR

C43177 A bottle which includes a device for applying its contents.

43 Container Type BOX C43178 A square or rectangular vessel, usually made of cardboard or plastic.

44 Container Type BOX, UNIT-DOSE C43179 A box that contains a single dose of a non-parenteral drug product. [Note: 

Boxes that contain 100 unit dose blister packs should be classified under 

blister pack, since this is the immediate container into which the dosage form 

is placed.]

45 Container Type CAN C43180 A cylindrical vessel, usually made of metal.

46 Container Type CANISTER C43181 A type of can for holding a drug product.

47 Container Type Canisters, lined C96143 A round container that has an inner layer of a material different from what the 

canister is composed of.
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48 Container Type CAPSULE C92708 A drug packaging type usually in a cylindrical shape with rounded ends. 

Capsule shells may be made from gelatin, starch, or cellulose, or other suitable 

materials, may be soft or hard, and are filled with solid or liquid drug products. 

It is not intended to be swallowed (like the dosage form) but instead is holding 

the drug such as for an inhalation powder or for oral granules intended only 

for sprinkling.

49 Container Type CARTON C43182 A cardboard box or container which is usually considered a secondary 

packaging component.

50 Container Type CARTRIDGE C43183 A container consisting of a cylinder with a septum at one end, and a seal at the 

other end, which is inserted into a device to form a syringe which contains a 

single dose of a parenteral drug product.

51 Container Type CASE C43184 A receptacle for holding something (e.g., that into which some oral 

contraceptive blister packs are placed).

52 Container Type CELLO PACK C43185 A plastic 'clamshell' [thin plastic pre-formed structure for a device].

53 Container Type CONTAINER C43186 An object that can be used to hold things.

54 Container Type CUP C43187 A bowl-shaped container.

55 Container Type CUP, UNIT-DOSE C43188 A cup intended to hold a single dose of a non-parenteral drug product.

56 Container Type CYLINDER C43189 A container designed specifically to hold gases.

57 Container Type DEWAR C43190 A container, usually made of glass or metal, that has at least two walls with the 

space between each wall evacuated so as to prevent the transfer of heat. The 

inside of the container often has a coating (as silvering) on the inside to reduce 

heat transfer, and is used especially for storing liquefied gases or for 

experiments at low temperatures. The size can vary from that of a small 

thermos bottle up to that which may be mounted upon a large truck (also 

known as a 'cryogenic truck').

58 Container Type DIALPACK C43191 A dose pack container designed to assist with patient compliance. The patient 

turns a dial to the correct day and the correct dose is made available and the 

container indicates that the dose has been removed.

59 Container Type Dish, Petri C96141 A shallow dish with a lid used to culture cells.
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60 Container Type DOSE PACK C43192 A container in which a preselected dose or dose regimen of the medication is 

placed.

61 Container Type DRUM C43193 A straight-sided cylindrical shipping container with flat ends; one of which can 

be opened/closed.

62 Container Type Flask C96144 A container with a base wider than the narrow neck traditionally used for 

holding liquids.

63 Container Type FLEXIBLE 

INTERMEDIATE 

BULK CONTAINER

C79135 A receptacle with a body constructed of film, woven plastic, woven fabric, 

paper or combination thereof, together with any appropriate service 

equipment and handling devices, and if necessary, an inner coating or liner.

64 Container Type INHALER C16738 A device by means of which a medicinal product can be administered by 

inspiration through the nose or the mouth.

65 Container Type INHALER, REFILL C43194 A container of medication intended to refill an inhaler.

66 Container Type JAR C43195 A rigid container having a wide mouth and often no neck which typically holds 

solid or semisolid drug products.

67 Container Type JUG C43196 A large, deep container that has a narrow mouth, is typically fitted with a 

handle, and is used to hold liquids.

68 Container Type KIT C43197 A packaged set of related pharmaceutical or and/or drug delivery devices used 

for a particular medical activity or procedure including required 

documentation for kit components and the entire kit.

69 Container Type NOT STATED C48626 The package type is not stated or is unavailable.

70 Container Type PACKAGE C43233 The drug product container with any accompanying materials or components. 

This may include the protective packaging, labeling, administration devices.

71 Container Type PACKAGE, 

COMBINATION

C43198 A package in which two or more drug products that are normally available 

separately are now available together.

72 Container Type PACKET C43199 An envelope into which only one dose of a drug product, usually in the form of 

granules or powder, has been directly placed. Examples include aluminum foil 

packets into which alcohol swabs and pledgets are placed.

73 Container Type PAIL C79136 A watertight vessel, often cylindrical, that is usually fitted with a handle, and 

that may have a lid.

74 Container Type PATCH C82332 A drug delivery system that often contains an adhesive backing that is usually 

applied to an external site on the body. Its ingredients either passively diffuse 

from, or are actively transported from, some portion of the patch. Depending 
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upon the patch, the ingredients are either delivered to the outer surface of the 

body or into the body.

75 Container Type Plate, Microwell C96142 A flat dish type device with multiple wells for testing cellular material.

76 Container Type POUCH C43200 A flexible container used to protect or hold one or more doses of a drug 

product (e.g. a pouch into which oral contraceptive blister packs are inserted, 

and an overwrap pouch for large volume parenterals).

77 Container Type SUPERSACK C43201 A multilayer paper bag for shipping some solid bulk excipients, usually in the 

form of powder or granules.

78 Container Type SYRINGE C43202 A device for the administration of drug products that consists of a rigid barrel 

fitted with septum with a plunger at one end and a seal or needle at the other 

end. The needle assembly may be part of the device or separate.

79 Container Type SYRINGE, GLASS C43203 A device for the administration of parenteral drug products that consists of a 

rigid glass barrel fitted with septum with a plunger at one end and a seal or 

needle at the other end. The needle assembly may be part of the device or 

separate.

80 Container Type SYRINGE, 

PLASTIC

C43204 A device for the administration of parenteral drug products that consists of a 

rigid plastic barrel fitted with septum with a plunger at one end and a seal or 

needle at the other end. The needle assembly may be part of the device or 

separate.

81 Container Type TABMINDER C43205 A specialized package; it registers each time it is opened and is used for 

checking patient compliance to prescribed medication regimens.

82 Container Type TANK C43206 A large receptacle used for holding, transporting, or storing liquids or gases, 

and often referred to as a reservoir.

83 Container Type TRAY C53438 A shallow flat receptacle, with a raised edge or rim, used for carrying, holding, 

or displaying finished drug product in its primary or market package. A tray 

and its contents may be encased in shrink-wrapped plastic for shipping, or with 

a cover or an overwrap as part of a unit of use package or kit.

84 Container Type TUBE C42794 A flexible container for semisolid drug products which is flattened and crimped 

or sealed at one end and has a reclosable opening at the other.

85 Container Type TUBE, WITH 

APPLICATOR

C43207 A tube which is provided with a device (the applicator) for administering the 

dosage form. The applicator may be part of the tube closure or be separate.

86 Container Type VIAL C43226 A container designed for use with parenteral drug products.
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87 Container Type VIAL, 

DISPENSING

C43208 A vial that is used by the pharmacist to dispense the prescribed medication.

88 Container Type VIAL, GLASS C43209 A glass container designed for use with parenteral drug products.

89 Container Type VIAL, MULTIDOSEC43210 A vial intended to contain more than one dose of the drug product.

90 Container Type VIAL, PATENT 

DELIVERY 

SYSTEM

C43211 A vial that has a patented delivery system.

91 Container Type VIAL, PHARMACY 

BULK PACKAGE

C43212 A container of a sterile preparation whose contents are intended for use in a 

pharmacy admixture program and are restricted to the preparation of 

admixtures for infusion or, through a sterile transfer device, for the filling of 

empty sterile syringes.

92 Container Type VIAL, PIGGYBACK C43213 A vial that contains a parenteral preparation that can be attached directly to 

the tubing of a parenterally administered fluid.

93 Container Type VIAL, PLASTIC C43214 A plastic container designed for use with parenteral drug products.

94 Container Type VIAL, SINGLEDOSEC43215 A vial containing a single unit of a parenteral drug product.

95 Container Type VIAL, SINGLE-USE C43216 A vial where a single dose of a parenteral drug product can be removed, and 

then the vial and its remaining contents can be disposed.

96 Drug Product 

Component 

Function

Absorption 

modifier

C176637 An excipient included in formulations to improve the absorption of a 

pharmacologically active drug (e.g. permeation enhancer; transmucosal 

absorption enhancer; intestinal permeation enhancer; delivery agent; 

penetration enhancer; transdermal delivery agent).

97 Drug Product 

Component 

Function

Adhesive C89528 Substance capable of bonding together two surfaces (e.g. bioadhesive 

material).
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98 Drug Product 

Component 

Function

Adsorbent C176642 Agent used to bind another component from within a formulation, acting as a 

carrier, reservoir or sequestrant (e.g. water-absorbing agent). (Adapted from 

Medicinescomplete)

99 Drug Product 

Component 

Function

Air displacement C176643 Agent used to replace air in a product or pack with a gas phase of known 

composition during manufacturing. Example is widely used In reactors/mixing 

tanks with liquid products (e.g. air overlay; gas blanket). (Adapted from 

Medicinescomplete)

100 Drug Product 

Component 

Function

Anticaking agent C42654 Agent added to improve powder flow. Used to promote powder flow and to 

reduce the caking or clumping that can occur when powders are stored in bulk. 

In addition, glidants and anticaking agents reduce the incidence of bridging 

during the emptying of powder hoppers and during powder processing. (e.g. 

glidant). (Adapted from Medicinescomplete)

101 Drug Product 

Component 

Function

Antioxidant C275 Agent used to stabilize a system against oxidative degradation. (Adapted from 

Medicinescomplete)

102 Drug Product 

Component 

Function

Binder C42647 Impart cohesive qualities to powdered material (e.g. binding agent or wet 

binder). (Pharmaceutical Excipients: A review Shilpa P Chaudhari and Pradeep 

S Patil Marathwada Mitra Mandal's College of Pharmacy, Thergaon, Pune, 

Maharashtra, India. USP <1059>)

103 Drug Product 

Component 

Function

Buffering agent C70815 Agent used to stabilize pH within a defined range. (Adapted from 

Medicinescomplete)

104 Drug Product 

Component 

Function

Bulking agent C176644 To provide a pharmaceutically elegant freeze-dried cake. (Adapted from USP 

<1059>)

105 Drug Product 

Component 

Function

CAPSULE C92708 A drug packaging type usually in a cylindrical shape with rounded ends. 

Capsule shells may be made from gelatin, starch, or cellulose, or other suitable 

materials, may be soft or hard, and are filled with solid or liquid drug products.

106 Drug Product 

Component 

Carrier C176645 Agents designed to interact with, and enhance the properties, of active 

pharmaceutical ingredients (APIs). Carrier excipients promote various 
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Function ingredient qualities and have become a valuable asset for drug formulators. 

Used to help deposit the active ingredient in the lung and may have a 

secondary role in diluting the active to ensure that dosages can be properly 

metered (e.g. solid carrier; sorbent; carbon dioxide). (Adapted from American 

Pharmaceutical Review)

107 Drug Product 

Component 

Function

Chelating agent C360 Used to sequester ions from solution and to form stable complexes (e.g. 

sequestering agent). (Pharmaceutical Excipients: A review Shilpa P Chaudhari 

and Pradeep S Patil Marathwada Mitra Mandal's College of Pharmacy, 

Thergaon, Pune, Maharashtra, India. USP <1059>)

108 Drug Product 

Component 

Function

Coloring agent C42656 Agent to impart hue to a component (e.g. color retention agent, dye).

109 Drug Product 

Component 

Function

Complexing 

agent

C176646 Agent added to combine with another component, commonly to maintain or 

improve solubility or chemical stability. (Adapted from Medicinescomplete)

110 Drug Product 

Component 

Function

Cryoprotectant C53306 Agent added to prevent cell damage during freeze-drying. (Adapted from 

Medicinescomplete)

111 Drug Product 

Component 

Function

Denaturant C176647 Agent added to make unfit to drink an ethanol containing product.

112 Drug Product 

Component 

Function

Disintegrant C42648 An agent used to facilitate breakup or disintegration after administration. 

Functional components that are added to formulations to promote rapid 

disintegration into smaller units and to allow a drug substance to dissolve 

more rapidly. (Pharmaceutical Excipients: A review Shilpa P Chaudhari and 

Pradeep S Patil Marathwada Mitra Mandal's College of Pharmacy, Thergaon, 

Pune, Maharashtra, India. USP <1059>)

113 Drug Product 

Component 

Function

Dispersing agent C42662 Agent added to prevent aggregation in liquid formulations. (Adapted from 

Medicinescomplete)
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114 Drug Product 

Component 

Function

Effervescent 

agent

C176638 Effervescent excipients are used in powders and tablets. They are commonly 

used with acidic agents to cause a reaction that produces carbon dioxide. The 

carbon dioxide leads to a fizzing of the effervescent powder. (Adapted from 

American Pharmaceutical Review)

115 Drug Product 

Component 

Function

Emollient C176632 Agent added to topical formulations to promote softening of the skin. Used in 

topical preparations to impart lubrication, spreading ease, texture, and 

softening of the skin and to counter the potentially drying/irritating effect of 

surfactants on the skin (e.g. skin protectant). (Adapted from 

Medicinescomplete)

116 Drug Product 

Component 

Function

Emulsifying 

Excipient

C73477 Agent added to promote mixing of immiscible phases (e.g. fluorocarbon 

emulsifying agent; emulsifier; emulsifying salt). (Adapted from 

Medicinescomplete)

117 Drug Product 

Component 

Function

Emulsion 

stabilizing agent

C176633 Agent added to improve stability against phase separation. (Adapted from 

Medicinescomplete)

118 Drug Product 

Component 

Function

Filler C42650 Make up the bulk of solid unit dosage forms when drug itself is inadequate to 

produce the bulk. Components that are incorporated into tablet or capsule 

dosage forms to increase dosage form volume or weight (e.g. diluent; dry 

powder inhalation; bulking agent). (Pharmaceutical Excipients: A review Shilpa 

P Chaudhari and Pradeep S Patil Marathwada Mitra Mandal's College of 

Pharmacy, Thergaon, Pune, Maharashtra, India. USP <1059>)

119 Drug Product 

Component 

Function

Film coating 

agent

C176648 Agent used to produce a cosmetic or functional layer on the outer surface of a 

dosage form. Agents used to mask unpleasant tastes or odors, improve 

ingestion and appearance, protect active ingredients from the environment, 

and modify the release of the active ingredient or product subcomponent (e.g. 

coating agent; film-forming agent; film former; granulating agent; granulating 

fluid; film-coating dispersion medium). (Adapted from Medicinescomplete)

120 Drug Product 

Component 

Function

Foam stabilizing 

agent

C176634 Agent added to improve physical stability of foam (e.g. foaming agent).

(Adapted from Medicinescomplete)
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121 Drug Product 

Component 

Function

Free radical 

scavenger

C176649 Used to preferentially interact with oxidative or reductive free radicals that 

otherwise would result in degradation of formulation components. (Adapted 

from USP <1059>)

122 Drug Product 

Component 

Function

Gelling agent C176650 Agent added to produce a gel texture in a product. (Adapted from 

Medicinescomplete)

123 Drug Product 

Component 

Function

Humectant C176651 Humectants can be used in topical dosage forms to increase the solubility of a 

chemical compound's active ingredients, increasing the active ingredients' 

ability to penetrate skin, or its activity time. Examples: propylene glycol, 

sorbitol solution, ammonium alginate, cyclomethicone, glycerin, polydextrose, 

sodium hyaluronate, and sodium lactate.

124 Drug Product 

Component 

Function

Ink C42657 A colored fluid or paste used for writing, drawing, typically used to identify a 

product and its strength.

125 Drug Product 

Component 

Function

Lubricant C42653 Agent added to reduce friction effects during processing or use. Used to 

reduce the frictional forces between particles and between particles and 

metal-contact surfaces of manufacturing equipment (e.g. tablet ejection; 

antiadherent; antistat; glidant). (Adapted from Medicinescomplete)

126 Drug Product 

Component 

Function

Lyophilization aid C176652 Agent added to produce suitable physical properties in a freeze-dried product.

(Adapted from Medicinescomplete)

127 Drug Product 

Component 

Function

Matrix-forming 

agent

C176653 Polymers added to sustained release formulations to control and maintain the 

rigidity of the matrix over a prolonged period (e.g., sustained-release agent; 

matrix for sustained release; rate-controlling polymer for sustained release).

(Adapted from "The Role of Oral Controlled Release Matrix Tablets in Drug 

Delivery Systems", Ali Nokhodchi1, Shaista Raja1, Pryia Patel1, Kofi Asare-Addo 

BioImpacts, 2012, 2 (4), 175-187)

128 Drug Product 

Component 

Function

Microencapsulati

ng agent

C176654 Agent used to form microcapsules with desirable physical properties. (Adapted 

from Medicinescomplete)
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129 Drug Product 

Component 

Function

Ointment base C176655 A nonaqueous vehicle for topical products. The major component of an 

ointment and controls its physical properties. (Adapted from 

Medicinescomplete)

130 Drug Product 

Component 

Function

Opacifier C176656 Agent added to reduce light transmission in a product (e.g., opacifying agent).

(Adapted from Medicinescomplete)

131 Drug Product 

Component 

Function

Organoleptic 

agent

C176635 An agent added to modify color, flavor, taste (e.g., flavoring agent; flavor 

enhancer; sweetening agent; taste-masking agent).

132 Drug Product 

Component 

Function

Osmotic agent C176657 Material used to provide osmotic pressure differential in osmotic pump-based 

drug product delivery systems.

133 Drug Product 

Component 

Function

pH modifier C176658 Substance added to alter the acidity or basicity (e.g., acidity regulator; 

acidifying agent/alkalizing agent; acid; base).

134 Drug Product 

Component 

Function

Plasticizer C55826 Agent added to promote flexibility of films or coatings (e.g., plasticizing agent).

(Adapted from Medicinescomplete)

135 Drug Product 

Component 

Function

Polishing agent C176659 Agent used to impart an attractive sheen to coated tablets (e.g., tablet 

polishing agent).

136 Drug Product 

Component 

Function

Polymers for 

ophthalmic use

C176660 Used in ophthalmic preparations to enhance the retention of active 

ingredients by reducing the amount of product that is lost from the eye when 

the patient blinks. In addition, polymers also can be components of artificial 

tears. (Adapted from USP <1059>)

137 Drug Product 

Component 

Preservative C42659 An agent added to extend the shelf-life of a formulation (e.g., antibacterial 

agent; antifungal agent preservative; fungicides; antimicrobial preservative; 

antiviral agent preservative; viricides; sterilizing agent; glazing agent).
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Function

138 Drug Product 

Component 

Function

Propellant C176661 Developing pressure in container which expels the product. Used in 

pharmaceuticals (nasal sprays and respiratory and topical formulations), 

cosmetics, and foods to provide force to expel contents from a container (e.g.,

aerosol propellant). (Pharmaceutical Excipients: A review Shilpa P Chaudhari 

and Pradeep S Patil Marathwada Mitra Mandal's College of Pharmacy, 

Thergaon, Pune, Maharashtra, India. USP <1059>)

139 Drug Product 

Component 

Function

Reducing agent C176639 Reduces oxidation state of product component to produce desired active 

component/ingredient.

140 Drug Product 

Component 

Function

Release 

modifying agent

C176662 Substances added to the formulation to alter the release profile of the active 

substance (e.g., release modifier; release agent; modifying agent; extended 

release agent; controlled release agent; latex particle coating agent).

141 Drug Product 

Component 

Function

Solubilizing agent C176640 Enhance solubility of the active substance. (Pharmaceutical Excipients: A 

review Shilpa P Chaudhari and Pradeep S Patil Marathwada Mitra Mandal's 

College of Pharmacy, Thergaon, Pune, Maharashtra, India.)

142 Drug Product 

Component 

Function

Solvent C45790 The liquid in which a solute is dissolved to form a solution.

143 Drug Product 

Component 

Function

Stabilizer C176636 Agent added to preserve product integrity and prevent degradation (e.g.,

stabilizing agent; colloid stabilizing agent).

144 Drug Product 

Component 

Function

Suppository base C176663 Agent used as the carrier for other ingredients in suppository formulations. 

Used in the manufacture of suppositories (for rectal administration) and 

pessaries (for vaginal administration). They can be hydrophobic or hydrophilic,

(Adapted from Medicinescomplete)

145 Drug Product 

Component 

Surfactant C42739 Substances used to enhance stability by reducing surface tension (e.g., anionic 

surfactant; cationic surfactant; nonionic surfactant).
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Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

# PQ/CMC Data 

Element Name

Valid Values NCIt Concept 

Codes

Valid Value Meaning

Function

146 Drug Product 

Component 

Function

Suspending 

agent

C42660 A non-surface active polymer or a surface-active substance added to a 

suspension, to improve the separation of particles and to prevent settling or 

clumping (e.g. dispersing agent).

147 Drug Product 

Component 

Function

Tonicity agent C176641 Agent added to alter osmotic potential of liquid formulations. (Adapted from 

Medicinescomplete)

148 Drug Product 

Component 

Function

Transdermal 

delivery 

component

C176664 A component of a transdermal system otherwise not covered by other terms.

149 Drug Product 

Component 

Function

Transfer ligand C176665 Used in the preparation radiopharmaceuticals to transfer a relatively weak 

chelating ligand to the principal chelating ligand or complexing moiety. (USP 

<1059>)

150 Drug Product 

Component 

Function

Vehicle C927 A substance that facilitates the use of a drug, or other material mixed with it, 

not covered by other terms (e.g., oleaginous vehicle).

151 Drug Product 

Component 

Function

Viscosity 

modifier

C176666 Viscosity modifiers are designed to change the thickness or texture of 

pharmaceutical ingredients. Viscosity modifiers can include such products as 

thickeners, texturizers, gelation agents and stiffening agents (e.g., stiffening 

agent; thickener; thickening agent; viscosity-increasing agent; firming agent).

(Adapted from American Pharmaceutical Review)

152 Drug Product 

Component 

Function

Water-repelling 

agent

C176667 An agent used to enhance hydrophobic properties.

153 Drug Product 

Component 

Function

Wetting agent C176668 An agent added to a liquid to reduce its surface tension and make it more 

effective in spreading over and penetrating surfaces.
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Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

C: Terminologies for Units Of Measure

All units of measure for quantitative values must use the FHIR unit value set. See https://build.fhir.org/valueset-ucum-units.html for a list of 

values. The following table lists the common UCUM codes used in PQ/CMC. This is the value set that will constrain the profiles in the IG. The 

code system will be UCUM in compliance with the FHIR standard. If the acceptance criterium is a qualitative value, then no unit is needed.

# PQ/CMC Data 

Element Name

Valid values Display Value NCIt Concept Code

1 Unit of Measure % Percent Unit C48570

2 Unit of Measure %{VolumeToVolume} Percent Volume per Volume C48571

3 Unit of Measure %{WeightToVolume} Percent Mass per Volume C48527

4 Unit of Measure %{WeightToWeight} Percent Mass per Mass C48528

5 Unit of Measure (m2.d) Unit per Square Meter per 

Day

C73783

6 Unit of Measure [Btu] British Thermal Unit C67196

7 Unit of Measure [CFU] Colony Forming Unit C68742

8 Unit of Measure [degF] Degree Fahrenheit C44277

9 Unit of Measure [EU] Ehrlich Unit C96599

10 Unit of Measure [in_i] Inch C48500

11 Unit of Measure [IU] International Unit C48579

12 Unit of Measure [lb_av] Pound C48531

13 Unit of Measure [lbf_av] Linear Foot Pound C139134

14 Unit of Measure [oz_av] Ounce C48519

15 Unit of Measure [pH] pH C45997

16 Unit of Measure [ppb] Part Per Billion C70565

17 Unit of Measure [ppm] Part Per Million C48523

18 Unit of Measure [ppth] Part per Thousand C69112

19 Unit of Measure [pptr] Part Per Trillion C70566

20 Unit of Measure [psi] Pound per Square Inch C67334

21 Unit of Measure [pt_us] Pint C48529

22 Unit of Measure [qt_us] Quart Dry US C69118

23 Unit of Measure {actuation} Actuation Dosing Unit C122629

24 Unit of Measure {can} Can Dosing Unit C48479
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Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

# PQ/CMC Data 

Element Name

Valid values Display Value NCIt Concept Code

25 Unit of Measure {tbl} Tablet Dosing Unit C48542

26 Unit of Measure {tot} Particle Total Count C171022

27 Unit of Measure {vial} Vial Dosing Unit C48551

28 Unit of Measure a Year C29848

29 Unit of Measure Cel Degree Celsius C42559

30 Unit of Measure cm Centimeter C49668

31 Unit of Measure mL Milliliter C28254

32 Unit of Measure d Day C25301

33 Unit of Measure deg Degree Unit of Plane Angle C68667

34 Unit of Measure g Gram C48155

35 Unit of Measure gal Gallon US C48580

36 Unit of Measure h Hour C25529

37 Unit of Measure K Kelvin C42537

38 Unit of Measure kg Kilogram C28252

39 Unit of Measure kgf Kilogram-Force C70471

40 Unit of Measure ku Kilodalton C105491

41 Unit of Measure L Liter C48505

42 Unit of Measure m Meter C41139

43 Unit of Measure m2 Square Meter C42569

44 Unit of Measure m3 Cubic Meter C42570

45 Unit of Measure mg Milligram C28253

46 Unit of Measure mg% Milligram per Deciliter C67015

47 Unit of Measure min Minute C48154

48 Unit of Measure mm Millimeter C28251

49 Unit of Measure mmol Millimole C48513

50 Unit of Measure mo Month C29846

51 Unit of Measure mol Mole C42539

52 Unit of Measure mosm Milliosmole C67318

53 Unit of Measure ms Millisiemens C176690

54 Unit of Measure N Newton C42546

55 Unit of Measure ng Nanogram C48516

56 Unit of Measure nm Nanometer C67328

57 Unit of Measure nmol Nanomole C48517
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Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

# PQ/CMC Data 

Element Name

Valid values Display Value NCIt Concept Code

58 Unit of Measure pg Picogram C64551

59 Unit of Measure pmol Picomole C65045

60 Unit of Measure rad Radian C42543

61 Unit of Measure s Second C42535

62 Unit of Measure u Unified Atomic Mass Unit C41127

63 Unit of Measure u Atomic Mass Unit C64559

64 Unit of Measure U Enzyme Unit C64778

65 Unit of Measure ug Microgram C48152

66 Unit of Measure uL Microliter C48153

67 Unit of Measure um Micron C48510

68 Unit of Measure umho Microsiemens C154859

69 Unit of Measure umol Micromole C48509

70 Unit of Measure wk Week C29844

D: Terminologies for NCIt GENC Country Codes

All Country Codes used in PQ/CMC are available via the spreadsheet on the NCIt site at 

https://evs.nci.nih.gov/ftp1/FDA/PQCMC/PQCMC_NCIt_Subsets.xls.

The GENC country codes are available in the GENC worksheet of the above spreadsheet.

END OF SECTION 7
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Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

Section 8: Glossary

Acronym Description

ANADA Abbreviated New Animal Drug Application

ANDA Abbreviated New Drug Application

APhA American Pharmacists Association

BLA Biologics License Application

CAS Chemical Abstract Service

CBER Center for Biologics Evaluation and Research

CDER Center for Drug Evaluation and Research

CMC Chemistry Manufacturing & Controls

CFR Code of Federal Regulations

CTD Common Technical Document

CVM Center for Veterinary Medicine

eCTD Electronic Common Technical Document

FDA Food and Drug Administration

FDASIA Food and Drug Administration Safety and Innovation Act

FHIR Fast Health Interoperability Resources

HL7 Health Level Seven

ICH International Council for Harmonisation

ISO IDMP International Organization for Standardization Identification of Medicinal Products

INN International Nonproprietary Name

INAD Investigational New Animal Drug

IND Investigational New Drug Application

IUPAC International Union of Pure and Applied Chemistry

JINAD Generic Investigational New Animal Drugs

MF Master Files
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Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

Acronym Description

NADA New Animal Drug Application

NDA New Drug Application

NCI EVS National Cancer Institute – Enterprise Vocabulary Service

PQ/CMC Pharmaceutical Quality/Chemistry, Manufacturing & Controls

SME Subject Matter Expert

SPL Structured Product Labeling

UNII Unique Ingredient Identifier

USAN United States Adopted Name

WHO World Health Organization
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Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange

Appendix A: Examples PQ/CMC Drug Product Strength

END OF DOCUMENT