Drugs

Pharmaceutical Quality/CMC

Below is a sortable table of Pharmaceutical Quality/CMC Guidances:

*Note: The category “Chemistry, Manufacturing, and Controls (CMC) is renamed to Pharmaceutical Quality/CMC

the word new in a red box Note:  Once finalized, the Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry will supersede the Comparability Protocols -- Chemistry, Manufacturing, and Controls Information draft guidance from 2003. 

The guidance document entitled "Submitting Documentation for the Manufacturing of and Controls for Drug Products” was withdrawn 4/14/2015.  This guidance was withdrawn because many of the recommendations were obsolete and have been more recently addressed in FDA and ICH guidance documents, including, but not limited to:
 

Additional information is available on CDER’s web site (www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm).

If you have questions about submission of information on manufacturing and controls for drug products, please contact the Office of Communications, Division of Drug Information toll-free at 855-543-3784 (toll 301-796-3400) or by email at druginfo@fda.hhs.gov.

CategoryTitleTypeDate
Pharmaceutical Quality/CMC Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products (PDF - 230KB) Draft Guidance 04/22/16
Pharmaceutical Quality/CMC Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (PDF - 33KB) Final Guidance 07/01/97
Pharmaceutical Quality/CMC Changes to an Approved NDA or ANDA (PDF - 173KB) Final Guidance 04/01/04
Pharmaceutical Quality/CMC Changes to an Approved NDA or ANDA: Questions and Answers (PDF - 35KB) Final Guidance 01/01/01
Pharmaceutical Quality/CMC Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes (PDF - 24KB) Final Guidance 11/19/04
Pharmaceutical Quality/CMC CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports (PDF - 106KB) Final Guidance 03/04/14
Pharmaceutical Quality/CMC Comparability Protocols -- Chemistry, Manufacturing, and Controls Information (PDF - 195KB) Draft Guidance 02/25/03
Pharmaceutical Quality/CMC Container Closure Systems for Packaging Human Drugs and Biologics (PDF - 164KB) Final Guidance 05/01/99
Pharmaceutical Quality/CMC Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers (PDF - 34KB) Final Guidance 05/01/02
Pharmaceutical Quality/CMC Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products Final Guidance 04/01/96
Pharmaceutical Quality/CMC Development of New Stereoisomeric Drugs Final Guidance 05/01/92
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Drug Master Files: Guidelines Final Guidance 09/01/89
Info helps to master FDA’s list of Drug Master Files (DMFs) and info on submission of DMFs to agency. FDA provides info on DMF list, status of DMF, types of DMF, and more. Drug Master Files (DMFs) Additional Information regarding DMF's
Pharmaceutical Quality/CMC Drug Master Files for Bulk Antibiotic Drug Substances (PDF - 23KB) Final Guidance 11/01/99
Pharmaceutical Quality/CMC Environmental Assessment of Human Drug and Biologics Applications (PDF - 188KB) Final Guidance 07/01/98
Pharmaceutical Quality/CMC Format and Content for the CMC Section of an Annual Report (PDF - 29KB) Final Guidance 09/01/94
Clinical/Medical; Pharmaceutical Quality/CMC Immunogenicity Assessment for Therapeutic Protein Products (PDF - 242KB) Final Guidance 08/13/14
Pharmaceutical Quality/CMC Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (PDF - 74KB) Final Guidance 10/11/11
Pharmaceutical Quality/CMC INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information (PDF - 283KB) Final Guidance 05/20/03
Pharmaceutical Quality/CMC IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (PDF - 30KB) Final Guidance 05/01/01
This is the Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations. Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (PDF - 88KB) Final Guidance 07/15/99
Pharmaceutical Quality/CMC Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (PDF - 120KB) Final Guidance 04/04/18
Pharmaceutical Quality/CMC Monoclonal Antibodies Used as Reagents in Drug Manufacturing (PDF - 29KB) Final Guidance 03/01/01
Pharmaceutical Quality/CMC Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations (PDF - 449KB) Draft Guidance (Revised) 04/18/18
Pharmaceutical Quality/CMC Nasal Spray and Inhalation Solution, Suspension, and Drug Products (PDF - 285KB) Final Guidance 07/01/02
Pharmaceutical Quality/CMC NDAs: Impurities in Drug Substances (PDF - 11KB) Final Guidance 02/01/00
Pharmaceutical Quality/CMC Orally Disintegrating Tablets (PDF - 52KB) Final Guidance 12/17/08
Pharmaceutical Quality/CMC PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites (PDF - 76KB) Final Guidance 04/28/98
Pharmaceutical Quality/CMC Regulatory Classification of Pharmaceutical Co-Crystals (PDF - 87KB) Revised Final Guidance 02/14/18
Pharmaceutical Quality/CMC Residual Drug in Transdermal and Related Drug Delivery Systems (PDF - 44KB) Final Guidance 08/16/11
Pharmaceutical Quality/CMC Residual Solvents in Drug Products Marketed in the United States (PDF - 52KB) Final Guidance 11/24/09
Pharmaceutical Quality/CMC Reviewer Guidance, Validation of Chromatographic Methods (PDF - 703KB) Final Guidance 11/01/94
Pharmaceutical Quality/CMC Size of Beads in Drug Products Labeled for Sprinkle. (PDF - 148KB) Final Guidance 05/02/12
Pharmaceutical Quality/CMC SUPAC: Manufacturing Equipment Addendum (PDF - 213KB) Final Guidance 12/01/14
Pharmaceutical Quality/CMC SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (PDF - 60KB) Final Guidance 11/01/95
Pharmaceutical Quality/CMC SUPAC-IR Questions and Answers about SUPAC-IR Guidance Final Guidance 02/18/97
Pharmaceutical Quality/CMC 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 (PDF - 215KB) Final Guidance 10/06/97
Pharmaceutical Quality/CMC SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (PDF - 118KB) Final Guidance 05/01/97
Pharmaceutical Quality/CMC Tablet Scoring:Nomenclature, Labeling, and Data for Evaluation (PDF - 56KB) Final Guidance 03/13/13
Pharmaceutical Quality/CMC Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products Final Guidance 12/05/12
Pharmaceutical Quality/CMC Analytical Procedures and Methods Validation for Drugs and Biologics (PDF - 134KB) Final Guidance 07/24/15
Pharmaceutical Quality/CMC Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products (PDF - 77KB) Final Guidance 06/24/15
Pharmaceutical Quality/CMC Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry (PDF - 136KB) Final Guidance 02/18/16
Pharmaceutical Quality/CMC Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs (PDF - 14KB) Final Guidance 12/01/00
Pharmaceutical Quality/CMC ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information (PDF - 110KB) Final Guidance 07/06/07
Pharmaceutical Quality/CMC ANDAs: Impurities in Drug Substances (PDF - 136KB) Final Guidance 07/15/09
Pharmaceutical Quality/CMC ANDAs: Impurities in Drug Products (PDF - 155KB) Final Guidance 11/26/10
Pharmaceutical Quality/CMC ANDAs: Stability Testing of Drug Substances and Products (PDF - 30KB) Final Guidance 06/18/13
Pharmaceutical Quality/CMC ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers (PDF - 124KB) Final Guidance 05/14/14
Pharmaceutical Quality/CMC Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules (PDF - 89KB) Final Guidance 06/18/15
Pharmaceutical Quality/CMC Guidance for Industry - Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products (PDF) (PDF - 64KB) Final Guidance 02/01/08
Pharmaceutical Quality/CMC Development and Submission of Near Infrared Analytical Procedures (PDF - 176KB) Draft Guidance 03/30/15
Pharmaceutical Quality/CMC Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity (PDF - 69KB) Final Guidance 03/04/16
Pharmaceutical Quality/CMC Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry (PDF - 165KB) Draft Guidance 05/29/15
Pharmaceutical Quality/CMC and Pharmaceutical Quality/CGMP Submission of Quality Metrics Data Guidance for Industry (PDF - 340KB) Draft Guidance 11/23/16
Pharmaceutical Quality/CMC Botanical Drug Development: Guidance for Industry (PDF - 221KB) Final Guidance 12/28/16
Pharmaceutical Quality/CMC Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use (PDF - 113KB) Draft Guidance 10/21/15
Pharmaceutical Quality/CMC Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry (PDF - 71KB) Final Guidance 09/28/17
Generics/User Fees/ Pharmaceutical Quality/CMC Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry (PDF - 379KB) Final Guidance 10/04/17
Pharmaceutical Quality/CMC Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry (PDF - 200KB) Draft Guidance 04/19/16
Pharmaceutical Quality/CMC Quality Attribute Considerations for Chewable Tablets Guidance for Industry (PDF - 121KB) Draft Guidance 06/16/16
Pharmaceutical Quality/Manufacturing Standards (CGMP) Request for Quality Metrics...Technical Specifications Document: "Quality Metrics Technical Conformance Guide, Version 1.0“ has published (PDF - 114KB) Draft Guidance 06/24/16
Pharmaceutical Quality/CMC Elemental Impurities in Drug Products (PDF - 100KB) Draft Guidance 06/30/16
Pharmaceutical Quality - CMC Regulatory Classification of Pharmaceutical Co-Crystals- Draft (PDF - 82KB) Draft Guidance 08/16/16
Pharmaceutical Quality/CMC / Generics ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry (PDF - 151KB) Draft Guidance 11/03/17
Pharmaceutical Quality/CMC CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports (PDF - 93KB) Draft Guidance 08/08/17
Pharmaceutical Quality / CMC Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry (PDF - 235KB) Draft Guidance 12/15/17

Page Last Updated: 04/18/2018
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