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.
- Control of Nitrosamine Impurities in Human Drugs
- 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
- Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- Field Alert Report Submission: Questions and Answers
- Q12 Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex
- 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
- Medical Gases—Current Good Manufacturing Practice
- Current Good Manufacturing Practice Requirements for Combination Products
- Contract Manufacturing Arrangements for Drugs: Quality Agreements
- Q7 Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
- Pyrogen and Endotoxins Testing: Questions and Answers
- 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
- Pharmaceutical Components at Risk for Melamine Contamination
- Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
- Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
- PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
- Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice
- Container Closure Systems for Packaging Human Drugs and Biologics
- Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products