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                Guidance for Industry

Guidance for Industry

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          Chemistry Manufacturing and Controls (CMC) Guidances for Industry (GFIs) and Questions and Answers (Q&As)Guidance for Industry Chemistry Manufacturing and Controls (CMC) Guidances for Industry (GFIs) and Questions and Answers (Q&As)
  
  	
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    PrintCVM CMC Guidances and Q&AsOther CMC GuidancesCMC Guidance Documents Applicable to Minor Use or Minor Species (MUMS) Animal Drugs, Biotech Animal Drugs, and BiotherapeuticsCMC Guidance Documents Applicable to Generic Animal Drug Products and Drug Substances

CVM CMC Guidances and Q&As

Administrative and General

CVM GFI #106 The Use of Published Literature in Support of New Animal Drug Approvals
	CVM GFI #156 Comparability Protocols - Chemistry, Manufacturing, and Controls Information for New Animal Drugs
	CVM GFI #227 Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections
	CVM GFI #234 Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications
	Chemistry, Manufacturing, and Controls (CMC) Information Submitted to Both CDER and CVM
	Submitting Establishment Information to the Animal Drug Manufacturing System (ADMS)Master File and Drug Substance

CVM GFI #57 Preparation and Submission of Veterinary Master Files
	CVM GFI #92 (VICH GL10(R)) Impurities In New Veterinary Drug Substances
	CVM GFI #126 BACPAC I: Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation
	CVM GFI #169 Drug Substance Chemistry, Manufacturing, and Controls Information
	CVM GFI #216 Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use
	Common Questions Related to Type II Veterinary Master Files (VMFs)
	CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal ProductsManufacturing

CVM GFI #23 Medicated Free Choice Feeds - Manufacturing Control
	CVM GFI #253 Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products
	CVM GFI #254 Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products
	CVM GFI #258 Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds
	Manufacturing Considerations for Penicillin or Cephalosporin Animal Drugs
	Split Tablet StudiesAnalytical Controls

CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and Terminology
	CVM GFI #64 (VICH GL2) Validation of Analytical Procedures: Methodology
	CVM GFI #135 Validation of Analytical Procedures for Type C Medicated Feeds
	CVM GFI #136 Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods
	CVM GFI #137 Analytical Methods Description for Type C Medicated Feeds
	CVM GFI #176 (VICH GL39) Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances
	CVM GFI #177 (VICH GL40) Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products
	CVM GFI #238 Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications
	CVM GFI #264 Standardized Medicated Feed Assay Limits
	Compilation of FDA Guidance and Resources for in vitro Dissolution Testing of Immediate Release Solid Oral Dosage FormsImpurities

CVM GFI #92 (VICH GL10(R)) Impurities in New Veterinary Drug Substances
	CVM GFI #93 (VICH GL11(R)) Impurities in New Veterinary Medicinal Products
	CVM GFI #100 (VICH GL18 (R2)) Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)
	CVM GFI #211 Residual Solvents in Animal Drug Products Questions and Answers
	CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and AnswersStability

CVM GFI #5 Drug Stability Guidelines
	CVM GFI #73 (VICH GL3(R)) Stability Testing of New Veterinary Drug Substances and Medicinal Products
	CVM GFI #74 (VICH GL4) Stability Testing of New Veterinary Dosage Forms
	CVM GFI #75 (VICH GL5) Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal Products
	CVM GFI #91 (VICH GL8) Stability Testing for Medicated Premixes
	CVM GFI #99 (VICH GL17) Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products
	CVM GFI #198 (VICH GL45) Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products
	CVM GFI #219 (VICH GL51) Statistical Evaluation of Stability Data
	CVM GFI #242 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products
	CVM GFI #259 (VICH GL58) Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IVPost-approval Changes

CVM GFI #83 Chemistry, Manufacturing, and Controls Changes to an Approved NADA or ANADA
	CVM GFI #126 BACPAC I: Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation
	CVM GFI #271 Reporting and Mitigating Animal Drug Shortages
	CVM GFI #279 Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally ActingBack to the top

Other CMC Guidances

Other FDA guidances may also provide useful information for the submission of CMC information for animal drugs, including Cross-Center guidances, Center for Drug Evaluation and Research (CDER) guidances, and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidances. Any other Cross-Center, CDER, or ICH guidance pertaining to CMC information may also be considered applicable to animal drugs. Drug sponsors should contact CVM’s Division of Manufacturing Technologies if they have any questions regarding the applicability of a guidance to animal drugs. For further information, contact AskCVM@fda.hhs.gov.

Administrative and General Guidances

CDER/CBER/CVM GFI: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing
	CDER/CVM/ORA GFI: PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
	OC GFI: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
	CDER/CBER/CVM GFI: Contract Manufacturing Arrangements for Drugs: Quality Agreements
	CDER/CBER/CVM/ORA GFI: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
	CDER/CVM GFI: Pharmaceutical Components at Risk for Melamine Contamination
	CDRH/CDER/CBER/CVM GFI: Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex
	CDER GFI: Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation
	CDER/CVM GFI: Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry
	CDER/CBER/CVM GFI: Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency Guidance for Industry
	CDER/CBER/CVM GFI: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry
	CDER/CBER/CVM GFI: Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol
	CDER/CBER/CVM GFI: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring FacilitiesMaster File and Drug Substance Guidances

CDER GFI Drug Master Files: Guidelines
	CDER GFI Drug Master Files for Bulk Antibiotic Drug Substances
	CDER GFI: Regulatory Classification of Pharmaceutical Co-Crystals
	CDER GFI: Development of New Stereoisomeric Drugs
	ICH GFI Q7: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
	ICH GFI Q7: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers
	ICH GFI Q11: Development and Manufacture of Drug Substances
	ICH GFI Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and AnswersManufacturing Guidances

CDER/CVM GFI: Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
	CDER/CBER/CVM GFI: Process Validation: General Principles and Practices
	CDER/CBER/CVM GFI: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
	CDER/CBER/ORA GFI: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice
	CDER GFI: Quality Attribute Considerations for Chewable Tablets
	CDER GFI: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products – Chemistry, Manufacturing, and Controls Documentation
	CDER GFI: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations
	CDER GFI: Botanical Drug Development
	CDER GFI: Non-Penicillin Beta-Lactam Drugs: A cGMP Framework for Preventing Cross-Contamination
	CDER GFI: Microbiological Quality Considerations in Non-Sterile Drug Manufacturing
	ICH GFI Q8(R2): Pharmaceutical Development
	ICH GFI Q9: Quality Risk Management
	ICH GFI Q10: Pharmaceutical Quality System
	ICH GFI: Q8, Q9, and Q10 Questions and Answers (R4)
	CDER/CBER/CVM GFI: Changes to Disposable Manufacturing Materials: Questions and AnswersAnalytical Control Guidances

CDER/CVM GFI: Bioanalytical Method Validation
	CBER/CDER/CDRH/CVM GFI: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
	CDER/CBER/CVM/CDRH/ORA GFI: Pyrogen and Endotoxins Testing: Questions and Answers
	CDER GFI: Dissolution Testing of Immediate Release Solid Oral Dosage Forms
	CDER GFI: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
	CDER GFI: Inspection of Injectable Products for Visible Particulates Draft Guidance for IndustryContainer Closure Guidances

CDER/CBER GFI: Container Closure Systems for Packaging Human Drugs and Biologics
	CDER/CBER GFI: COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for IndustryImpurities Guidances

CDER/CBER/CVM GFI: Possible Dioxin/PCB Contamination of Drug and Biological ProductsPost-approval Changes Guidances

CDER GFI: PAC-ATLS: Postapproval Changes – Analytical Testing Laboratory Sites
	CDER GFI: SUPAC-MR: Modified Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation
	CDER GFI: SUPAC-IR: Immediate Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation
	CDER GFI: SUPAC-IR: Questions and Answers about SUPAC-IR Guidance
	CDER GFI: SUPAC-SS: Nonsterile Semisolid Dosage Forms: Scale-up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation
	CDER GFI: CMC Postapproval Manufacturing Changes to be Documented in Annual Reports
	ICH GFI Q12 Technical and Regulatory Considerations for Pharmaceutical Lifecycle Management Guidance for Industry
	ICH GFI Q12 Technical and Regulatory Considerations for Pharmaceutical Lifecycle Management Annex
	Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAsBack to the top

CMC Guidance Documents Applicable to Minor Use or Minor Species (MUMS) Animal Drugs, Biotech Animal Drugs, and Biotherapeutics

Guidances are available that may also provide useful information for the submission of CMC information for Minor Use or Minor Species (MUMS) animal drugs, biotech animal drugs, and biotherapeutics. These other guidances include Cross-Cutting guidances, CBER guidances, and ICH guidances. Any other guidances pertaining to CMC information in addition to those listed below may also be applicable to such animal drugs. Drug sponsors considering an approach outlined in these CMC guidances should contact CVM’s Division of Manufacturing Technologies if they have any questions regarding the applicability of a guidance to MUMS, biotech, or biotherapeutic animal drugs. For further information, contact AskCVM@fda.hhs.gov.

Administrative/General/Manufacturing Guidances

CBER/CDRH GFI: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use
	CDER/CBER GFI: For the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use
	CBER GFI: Guidance for Human Somatic Cell Therapy and Gene Therapy
	ICH GFI Q5D: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
	CBER GFI: Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use
	CBER GFI: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
	CBER GFI: Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)Analytical Controls Guidances

ICH GFI Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
	CBER GFI: Potency Tests for Cellular and Gene Therapy Products
	ICH GFI Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal OriginStability Guidances

ICH GFI Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological ProductsPost-approval Changes Guidances

CDER/CBER GFI: Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products
	ICH GFI Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
	CDER/CBER GFI: Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products
	CDER/CBER GFI: Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological ProductsBack to the top

CMC Guidance Documents Applicable to Generic Animal Drug Products and Drug Substances

CVM has guidances (including VICH guidances) that cover many CMC topics that are applicable not only to new animal drug applications, but also to original and supplemental abbreviated new animal drug applications (ANADAs) and generic investigational new animal drug files (JINADs). Other FDA guidances (i.e., CDER CMC guidances) may also provide useful information for the submission of CMC information for generic animal drugs. Any other guidance pertaining to CMC information in addition to those listed below may also be applicable to generic animal drugs. Drug sponsors should contact CVM’s Division of Manufacturing Technologies if they have any questions regarding the applicability of a guidance to generic animal drugs. For further information, contact AskCVM@fda.hhs.gov.

Manufacturing Guidances

CDER GFI: ANDAs: Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls InformationAnalytical Controls Guidances

CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and Terminology
	CVM GFI #64 (VICH GL2) Validation of Analytical Procedures: Methodology
	CVM GFI #176 (VICH GL39) Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical SubstancesImpurities Guidances

CVM GFI #92 (VICH GL10(R)) Impurities in New Veterinary Drug Substances
	CVM GFI #93 (VICH GL11(R)) Impurities in New Veterinary Medicinal Products
	CVM GFI #100 (VICH GL18) Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients
	CDER GFI: ANDAs: Impurities in Drug Products
	CDER GFI: ANDAs: Impurities in Drug SubstancesStability Guidances

CVM GFI #73 (VICH GL3(R)) Stability Testing of New Veterinary Drug Substances and Medicinal Products
	CVM GFI #75 (VICH GL5) Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal Products
	CVM GFI #91 (VICH GL8) Stability Testing for Medicated Premixes
	CVM GFI #198 (VICH GL45) Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal ProductsBack to the top

                                                                                  Content current as of:
      01/30/2024Guidance for Industry

          
                        Guidance by Number
          Guidances Under Development for 2023
          Newly Added Guidances
          Withdrawn/Replaced Guidances
 
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