FDA · Guidance
FDA 가이던스 문서
미국 FDA가 공개한 의약품 GMP·품질 관련 가이던스 문서를 발행일 순으로 선별해 정리했습니다. 가이던스는 FDA의 현재 견해를 담은 권고 문서로, 법적 구속력이 있는 규정(CFR)과는 구분해 읽어야 합니다. 최신 개정 여부는 반드시 공식 원문에서 확인하세요.
- 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
