FDA · Guidance
FDA guidance documents
Selected FDA guidance documents on drug GMP and quality, listed by publication date. Guidance documents state FDA's current thinking and are recommendations; read them separately from the legally binding regulations (CFR). Always check the official source for the latest revision.
- Container Closure Systems for Human Drugs and Biological Products
- Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts
- Q8 Q8, Q9, and Q10 Questions and Answers (R5)
- Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection
- Q3E Q3E Guideline for Extractables and Leachables
- Q3E Q3E Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs
- Q1 Q1 Stability Testing of Drug Substances and Drug Products
- Control of Nitrosamine Impurities in Human Drugs
- Container Closure System and Component Changes: Glass Vials and Stoppers
- Data Integrity for In Vivo Bioavailability and Bioequivalence Studies
- Q14 Q14 Analytical Procedure Development
- Q2(R2) Q2(R2) Validation of Analytical Procedures
- Q5A(R2) Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
- Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities
- M7(R2) M7(R2) ADDENDUM: APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES
- Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
- Q9(R1) Q9(R1) Quality Risk Management
- Q13 Q13 Continuous Manufacturing of Drug Substances and Drug Products
- Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA
- Q3D(R2) Q3D(R2) Guideline for Elemental Impurities
- Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination
- Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- Q3C(R8) Q3C(R8) Impurities: Guidance for Residual Solvents
- Q3C(R8) Q3C(R8) Impurities: Guidance for Residual Solvents
- Microbiological Quality Considerations in Non-Sterile Drug Manufacturing
- Q2(R1) Q2(R1) Validation of Analytical Procedures: Text and Methodology
- Field Alert Report Submission: Questions and Answers
- Q12 Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex
- Q12 Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
- Insanitary Conditions at Compounding Facilities
- Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products
- Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act
- Data Integrity and Compliance With Drug CGMP: Questions and Answers
- Elemental Impurities in Drug Products
- Q3C Q3C Tables and List Rev. 4
- Q7 Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers
- Questions and Answers on Current Good Manufacturing Practices for Drugs
- Q11 Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities)
- Q3C Q3C Maintenance Procedures
- Medical Gases—Current Good Manufacturing Practice
- Current Good Manufacturing Practice Requirements for Combination Products
- Submission of Quality Metrics Data
- Contract Manufacturing Arrangements for Drugs: Quality Agreements
- Q7 Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
- Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination
- Q11 Q11 Development and Manufacture of Drug Substances
- Q8 Q8, Q9, & Q10 Questions and Answers -- Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider)
- Pyrogen and Endotoxins Testing: Questions and Answers
- Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography
- PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide
- Process Validation: General Principles and Practices
- Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
- The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP)
- PET Drug Products - Current Good Manufacturing Practice (CGMP)
- Q8(R2) Q8(R2) Pharmaceutical Development
- Pharmaceutical Components at Risk for Melamine Contamination
- Questions and Answers on Current Good Manufacturing Practice Questions and Answers on Current Good Manufacturing Practice Requirements | General Provisions
- Q10 Q10 Pharmaceutical Quality System
- Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
- Current Good Manufacturing Practice for Phase 1 Investigational Drugs
- Q3A Q3A(R) Impurities in New Drug Substances
- Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
- Q3B Q3B(R) Impurities in New Drug Products (Revision 3)
- Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
- Q5E Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
- PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
- Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice
- Q1E Q1E Evaluation of Stability Data
- CPG Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval
- Q1A(R2) Q1A(R2) Stability Testing of New Drug Substances and Products
- Q1D Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
- Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers
- Q6A Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
- Q6B Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
- Container Closure Systems for Packaging Human Drugs and Biologics
- Q5D Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability
- Q3C Q3C: Appendix 6
- Q3C Q3C: Appendix 5
- Q3C Q3C: Appendix 4
- Q3C Q3C Impurities: Residual Solvents_2011
- Q2B Q2B Validation of Analytical Procedures: Methodology
- Q1C Q1C Stability Testing for New Dosage Forms
- Q5C Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
- Q1B Q1B Photostability Testing of New Drug Substances and Products
- Q5B Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
- Q2A Q2A Text on Validation of Analytical Procedures
- Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
- CPG Sec. 450.100 CGMP Enforcement Policy - OTC vs Rx Drugs
