Drugs

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.

CategoryTitleTypeDate
Pharmaceutical Quality/CMCSelection 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 Guidance10/02/18
Pharmaceutical Quality/CMC.Postapproval Changes to Drug Substances Guidance for Industry (PDF - 393KB)Draft guidance09/10/18
Pharmaceutical Quality/CMCQuality Attribute Considerations for Chewable Tablets Guidance for Industry (PDF - 169KB)Final Guidance08/20/18
BiopharmaceuticalsDissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances Guidance for Industry (PDF - 103KB)Final Guidance08/08/18
Pharmaceutical Quality/CMCElemental Impurities in Drug Products Guidance for Industry (PDF - 92KB)Final Guidance08/07/18
Pharmaceutical Quality/CMCUse 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 Guidance7/24/2018
Pharmaceutical Quality/Manufacturing Standards (CGMP) and Pharmaceutical Quality/CMCField Alert Report Submission: Questions and Answers Guidance for Industry (PDF - 123KB)Draft Guidance7/18/2018
International Council for Harmonisation - QualityQ12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline Guidance for Industry (PDF - 451KB)Draft Guidance5/30/2018
International Council for Harmonisation - QualityQ12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex (PDF - 223KB)Draft Guidance5/30/2018
International Council for Harmonisation - QualityQ7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers Guidance for Industry (PDF - 218KB)Final Guidance4/19/18
Pharmaceutical Quality/CMCMetered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations (PDF - 449KB)Draft Guidance, Revised4/18/18
Pharmaceutical Quality/CMCLiposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (PDF - 120KB)Final Guidance4/4/18
International Council for Harmonisation - QualityQ11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities) (PDF - 843KB)Final Guidance2/23/18
Pharmaceutical Quality/CMCRegulatory Classification of Pharmaceutical Co-Crystals (PDF - 87KB)Revised Final Guidance02/14/18
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP)Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (PDF - 556KB)Final Guidance01/18/18
BiopharmaceuticsWaiver 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 Guidance12/22/17
Pharmaceutical Quality / CMCDrug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry (PDF - 235KB)Draft Guidance12/15/17
LabelingGluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry (PDF - 136KB)Draft Guidance12/12/17
Pharmaceutical Quality/CMC / GenericsANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry (PDF - 151KB)Draft Guidance11/03/17
Generics/User Fees/ Pharmaceutical Quality/CMCCompleteness Assessments for Type II API DMFs Under GDUFA Guidance for Industry (PDF - 379KB)Final Guidance10/04/17
Pharmaceutical Quality/CMCAdvancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry (PDF - 71KB)Final Guidance09/28/17
Pharmaceutical Quality/CMCCMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports (PDF - 93KB)Draft Guidance08/08/17
Pharmaceutical Quality/Manufacturing Standards (CGMP)Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products (PDF - 72KB)Draft Guidance08/08/17
LabelingChild-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry (PDF - 96KB)Draft Guidance08/02/17
Pharmaceutical Quality/Manufacturing Standards (CGMP)Current Good Manufacturing Practice for Medical Gases (PDF - 219KB)Draft Guidance06/28/17
ProceduralExtending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles (PDF - 226KB)Draft Guidance04/24/17
Electronic SubmissionsProviding Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 112KB)Final Guidance04/07/17
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP)Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (PDF - 646KB)Final Guidance01/12/17
Pharmaceutical Quality/Manufacturing Standards (CGMP)Current Good Manufacturing Practice Requirements for Combination ProductsFinal Guidance01/10/17
Pharmaceutical Quality/CMCBotanical Drug Development: Guidance for Industry (PDF - 221KB)Final Guidance12/28/16
Pharmaceutical Quality/CMC and Pharmaceutical Quality/CGMPSubmission of Quality Metrics Data Guidance for Industry (PDF - 340KB)Draft Guidance11/23/16
Compliance; Pharmaceutical Quality/Manufacturing Standards (CGMP)Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF - 123KB)Final Guidance11/22/16
Pharmaceutical Quality - CMCRegulatory Classification of Pharmaceutical Co-Crystals- Draft (PDF - 82KB)Draft Guidance08/16/16
Pharmaceutical Quality/CMCElemental Impurities in Drug Products (PDF - 100KB)Draft Guidance06/30/16
Pharmaceutical Quality/Manufacturing Standards (CGMP)Technical Specifications Document: "Quality Metrics Technical Conformance Guide, Version 1.0“ has published (PDF - 114KB)Draft Guidance06/24/16
Pharmaceutical Quality/CMCQuality Attribute Considerations for Chewable Tablets Guidance for Industry (PDF - 121KB)Draft Guidance06/16/16
Pharmaceutical Quality/Manufacturing Standards (CGMP)Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF - 120KB)Draft Guidance04/14/16
Pharmaceutical Quality/CMCAssay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products (PDF - 230KB)Draft Guidance04/22/16
Pharmaceutical Quality/CMCComparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry (PDF - 200KB)Draft Guidance04/19/16
Pharmaceutical Quality/CMCImmunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry (PDF - 136KB)Final Guidance02/18/16
Pharmaceutical Quality/CMCLiposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (PDF - 146KB)Draft Guidance10/29/15
Pharmaceutical Quality/CMCSelection 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 Guidance10/21/15
BiopharmaceuticalsDissolution 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 Guidance07/31/15
Pharmaceutical Quality/CMCAnalytical Procedures and Methods Validation for Drugs and Biologics (PDF - 134KB)Final Guidance07/24/15
Pharmaceutical Quality/CMCAllowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products (PDF - 77KB)Final Guidance06/24/15
Pharmaceutical Quality/CMCSize, Shape, and Other Physical Attributes of Generic Tablets and Capsules (PDF - 89KB)Final Guidance06/18/15
LabelingNaming of Drug Products Containing Salt Drug Substances (PDF - 210KB)Final Guidance06/16/15
Pharmaceutical Quality/CMCEstablished Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry (PDF - 165KB)Draft Guidance05/29/15
Pharmaceutical Quality/CMCEnvironmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity (PDF - 69KB)Final Guidance03/04/16
Pharmaceutical Quality/CMCDevelopment and Submission of Near Infrared Analytical Procedures (PDF - 176KB)Draft Guidance03/30/15

Contact for Further Information:

CDER-OPQ-Inquiries@fda.hhs.gov

Page Last Updated: 11/14/2018
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