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  1. Development & Approval Process (Drugs)

Guidances and Manuals on Pharmaceutical Quality

Guidances and Manuals on Pharmaceutical Quality

This page provides quick access to guidances documents for industry on pharmaceutical quality topics, including drug application/license policies on quality. In addition to the guidance document resources below, CDER Manuals of Policies and Procedures (MAPPs) are approved instructions for internal practices and procedures followed by FDA and CDER staff to help standardize the drug review process and other activities.

Category Title Type Date

Pharmaceutical Quality/CMC

Bispecific Antibody Development Programs Guidance for Industry (PDF - 90 KB) Draft guidance 4/18/19
Pharmaceutical Quality / CMC Pharmaceutical Quality/Manufacturing Standards (CGMP) Quality Considerations for Continuous Manufacturing Guidance for Industry (PDF - 197 KB) Draft guidance 2/26/19
Pharmaceutical Quality/CMC Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection Guidance for Industry (PDF - 372 KB) Final Guidance 1/23/19
Pharmaceutical Quality/Manufacturing Standards (CGMP) Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF - 127 KB) Final Guidance 12/12/18
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (PDF - 476KB) Draft guidance 12/10/18
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 - 167KB) Final Guidance 10/02/18
Pharmaceutical Quality/CMC. Postapproval Changes to Drug Substances Guidance for Industry (PDF - 393KB) Draft guidance 09/10/18
Pharmaceutical Quality/CMC Quality Attribute Considerations for Chewable Tablets Guidance for Industry (PDF - 169KB) Final Guidance 08/20/18
Biopharmaceuticals Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances Guidance for Industry (PDF - 103KB) Final Guidance 08/08/18
Pharmaceutical Quality/CMC Elemental Impurities in Drug Products Guidance for Industry (PDF - 92KB) Final Guidance 08/07/18
Pharmaceutical Quality/CMC Use of Liquids and/or Soft Foods as  Vehicles for Drug Administration: General Considerations for Selection and In  Vitro Methods for Product Quality Assessments (PDF - 410KB) Draft Guidance 7/24/2018
Pharmaceutical Quality/Manufacturing Standards (CGMP) and Pharmaceutical Quality/CMC Field Alert Report Submission: Questions and Answers Guidance for Industry (PDF - 123KB) Draft Guidance 7/18/2018
International Council for Harmonisation - Quality Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline Guidance for Industry (PDF - 451KB) Draft Guidance 5/30/2018
International Council for Harmonisation - Quality Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex (PDF - 223KB) Draft Guidance 5/30/2018
International Council for Harmonisation - Quality Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers Guidance for Industry (PDF - 218KB) Final Guidance 4/19/18
Pharmaceutical Quality/CMC Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations (PDF - 449KB) Draft Guidance, Revised 4/18/18
Pharmaceutical Quality/CMC Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (PDF - 120KB) Final Guidance 4/4/18
International Council for Harmonisation - Quality Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities) (PDF - 843KB) Final Guidance 2/23/18
Pharmaceutical Quality/CMC Regulatory Classification of Pharmaceutical Co-Crystals (PDF - 87KB) Revised Final Guidance 02/14/18
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (PDF - 556KB) Final Guidance 01/18/18
Biopharmaceutics Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. Guidance for Industry (PDF - 161KB) Final Guidance 12/22/17
Pharmaceutical Quality / CMC Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry (PDF - 235KB) Draft Guidance 12/15/17
Labeling Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry (PDF - 136KB) Draft Guidance 12/12/17
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
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 Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry (PDF - 71KB) Final Guidance 09/28/17
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/Manufacturing Standards (CGMP) Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products (PDF - 72KB) Draft Guidance 08/08/17
Labeling Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry (PDF - 96KB) Draft Guidance 08/02/17
Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice for Medical Gases (PDF - 219KB) Draft Guidance 06/28/17
Procedural Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles (PDF - 226KB) Draft Guidance 04/24/17
Electronic Submissions Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 112KB) Final Guidance 04/07/17
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (PDF - 646KB) Final Guidance 01/12/17
Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice Requirements for Combination Products Final Guidance 01/10/17
Pharmaceutical Quality/CMC Botanical Drug Development: Guidance for Industry (PDF - 221KB) Final Guidance 12/28/16
Pharmaceutical Quality/CMC and Pharmaceutical Quality/CGMP Submission of Quality Metrics Data Guidance for Industry (PDF - 340KB) Draft Guidance 11/23/16
Compliance; Pharmaceutical Quality/Manufacturing Standards (CGMP) Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF - 123KB) Final Guidance 11/22/16
Pharmaceutical Quality - CMC Regulatory Classification of Pharmaceutical Co-Crystals- Draft (PDF - 82KB) Draft Guidance 08/16/16
Pharmaceutical Quality/CMC Elemental Impurities in Drug Products (PDF - 100KB) Draft Guidance 06/30/16
Pharmaceutical Quality/Manufacturing Standards (CGMP) Technical Specifications Document: "Quality Metrics Technical Conformance Guide, Version 1.0“ has published (PDF - 114KB) Draft Guidance 06/24/16
Pharmaceutical Quality/CMC Quality Attribute Considerations for Chewable Tablets Guidance for Industry (PDF - 121KB) Draft Guidance 06/16/16
Pharmaceutical Quality/Manufacturing Standards (CGMP) Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF - 120KB) Draft Guidance 04/14/16
Pharmaceutical Quality/CMC Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products (PDF - 230KB) Draft Guidance 04/22/16
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 Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry (PDF - 136KB) Final Guidance 02/18/16
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 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
Biopharmaceuticals Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs Guidance for Industry (PDF - 87KB) Draft Guidance 07/31/15
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 Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules (PDF - 89KB) Final Guidance 06/18/15
Labeling Naming of Drug Products Containing Salt Drug Substances (PDF - 210KB) Final Guidance 06/16/15
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 Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity (PDF - 69KB) Final Guidance 03/04/16
Pharmaceutical Quality/CMC Development and Submission of Near Infrared Analytical Procedures (PDF - 176KB) Draft Guidance 03/30/15

Contact for Further Information:

CDER-OPQ-Inquiries@fda.hhs.gov