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Guidance for Industry will supersede the Comparability Protocols -- Chemistry, Manufacturing, and Controls Information draft guidance from 2003. 

The guidance document entitled "Submitting Documentation for the Manufacturing of and Controls for Drug Products” was withdrawn 4/14/2015.  This guidance was withdrawn because many of the recommendations were obsolete and have been more recently addressed in FDA and ICH guidance documents, including, but not limited to: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

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Quality/CMC Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products (PDF - 230KB) Draft Guidance 04/22/16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Pharmaceutical Quality/CMC Comparability Protocols -- Chemistry, Manufacturing, and Controls Information (PDF - 195KB) Draft Guidance 02/25/03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
Pharmaceutical Quality/CMC Drug Master Files: Guidelines Final Guidance 09/01/89
Pharmaceutical Quality/CMC 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
Pharmaceutical Quality/CMC Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (PDF - 88KB) Final Guidance 04/22/14
Pharmaceutical Quality/CMC Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (PDF - 146KB) Draft Guidance 10/29/15
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 (PDF - 361KB) Draft Guidance 11/19/98
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 - 84KB) Final Guidance 04/25/13
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 The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use 09/01/97
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 to Modernize the Pharmaceutical Manufacturing Base; Draft Guidance for Industry; Availability (PDF - 63KB) Draft Guidance 12/23/15
Generics/User Fees/ Pharmaceutical Quality/CMC Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry (PDF - 432KB) Final Guidance 02/12/16
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 ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions Guidance for Industry (PDF - 315KB) Draft Guidance 06/19/17

Page Last Updated: 06/19/2017
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