Guidance for Industry

Container Closure Systems for

Packaging Human Drugs

and Biologics

Questions and Answers

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

May 2002

CMC
Guidance for Industry

Container Closure Systems for

Packaging Human Drugs

and Biologics

Questions and Answers

Additional copies are available from:

Office of Training and Communications

Division of Drug Information, HFD-240

Center for Drug Evaluation and Research

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

(Tel) 301-827-4573

http://www.fda.gov/cder/guidance/index.htm

or

 Office of Communication, Training and

Manufacturers Assistance, HFM-40

Center for Biologics Evaluation and Research

 Food and Drug Administration

1401 Rockville Pike, Rockville, MD 20852-1448

 http://www.fda.gov/cber/guidelines.htm

Fax: 1-888-CBERFAX or 301-827-3844

Phone: the Voice Information System at 800-835-4709 or 301-827-1800

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

May 2002

CMC
1

Guidance for Industry1

Container Closure Systems for Packaging

Human Drugs and Biologics

Questions and Answers

This document provides questions and answers relating to the guidance on Container Closure

Systems for Packaging Human Drugs and Biologics (the guidance).2 The questions are based on

those posed to CDER by applicants.

Q1: Table 5 of the guidance (section III.E.2) provides information on the American

Academy of Ophthalmology (AAO) uniform color coding system for the caps and labels

of topical ocular medications. Is there a source for current information on this coding

system?

A1: Current information on the AAO color coding system can be found on AAO’s Web

site at http:///www.aao.org (type color coding in the search entry box).

Q2: Section VI.B of the guidance states that container closure systems for on-site storage

have generally been considered a Current Good Manufacturing Practices (CGMP)

issue. However, the guidance goes on to state that if a firm plans to hold bulk drug

products3 in storage, then the container closure system and the maximum storage time

should be described and justified in the application. If this is a CGMP issue, does

information need to be included in the application?

 

1

This guidance has been prepared by the Packaging Technical Committee of the Chemistry, Manufacturing, and

Controls Committee (CMCCC) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug

Administration (FDA).

2

 A notice of availability for this guidance published in the Federal Register on July 7, 1999 (64 FR 36694).

3

 A bulk drug product means finished dosage form that has not yet been packaged into the container closure systems

intended for market and/or sale.

This guidance represents the Food and Drug Administration=s current thinking on this topic. It does not

create or confer any rights for or on any person and does not operate to bind FDA or the public. An

alternative approach may be used if such approach satisfies the requirements of the applicable statutes

and regulations.
2

A2: Information on container closure systems used for storage of bulk drug products,

other than biologics or protein drug products, need not be included in the application.

However, these container closure systems should be shown to be suitable for their

intended use. The suitability of the storage containers should be supported by data

retained by the applicant and/or manufacturer and should be made available during

FDA inspection upon demand. Information as requested in section VI.B. of the

packaging guidance should be included in the application on the container closure

system for storage prior to packaging or shipping of biologics and protein drug

products, including container closure suitability. This information should be provided

for biologics and proteins because, in general, there is greater potential for adverse

effects on the identity, strength, quality, purity, or potency of biologics and protein

drug products during storage or shipping.

Q3: Section VI.B of the guidance states that a container closure system for the

transportation of bulk drug products to contract packagers should be described in the

application; section VI.B also provides recommendations on information to include in

the application. However, different recommendations are provided for holding bulk

drug products in storage, and this situation appears to include shipping of bulk drug

products between applicant-owned manufacturing sites and applicant-owned

packaging sites. Why are the recommendations different for these similar situations?

A3: Information on container closure systems used for shipping (i.e., between applicant's

own facilities or contract facilities) and bulk drug products, other than biologics or

proteins, need not be included in the application. However, these container closure

systems should be shown to be suitable for their intended use. The suitability of the

storage containers should be supported by data retained by the applicant and/or

manufacturer and should be made available during FDA inspection upon demand.

Information as requested in section VI.B. of the packaging guidance on the container

closure system for storage (shipping) of biologics and protein drug products,

including container closure suitability, should be included in the application. This

information should be provided for biologics and proteins because, in general, there is

greater potential for adverse effects on the identity, strength, quality, purity, or

potency of biologics and proteins during storage or shipping.