US · 21 CFR
미국 연방규정 21 CFR (GMP)
미국 연방규정집(Code of Federal Regulations) Title 21 가운데 의약품 현행 우수제조관리기준(CGMP)을 담은 Part 210(총칙)과 Part 211(완제의약품 CGMP) 전 조항을 조문 단위로 정리했습니다. 자료실의 다른 컬렉션이 가이드라인·기준서인 것과 달리 이 컬렉션은 법적 구속력을 갖는 규정 원문 그 자체입니다. FDA가 권고 형태로 내는 문서는 바로 앞의 'FDA 가이던스 문서' 컬렉션에 있습니다. 각 조항은 공식 원문(eCFR)으로 바로 연결됩니다. 개정 이력과 최신본은 반드시 공식 원문에서 확인하세요.
- 21 CFR 211.1 Scope.
- 21 CFR 211.3 Definitions.
- 21 CFR 211.22 Responsibilities of quality control unit.
- 21 CFR 211.25 Personnel qualifications.
- 21 CFR 211.28 Personnel responsibilities.
- 21 CFR 211.34 Consultants.
- 21 CFR 211.42 Design and construction features.
- 21 CFR 211.44 Lighting.
- 21 CFR 211.46 Ventilation, air filtration, air heating and cooling.
- 21 CFR 211.48 Plumbing.
- 21 CFR 211.50 Sewage and refuse.
- 21 CFR 211.52 Washing and toilet facilities.
- 21 CFR 211.56 Sanitation.
- 21 CFR 211.58 Maintenance.
- 21 CFR 211.63 Equipment design, size, and location.
- 21 CFR 211.65 Equipment construction.
- 21 CFR 211.67 Equipment cleaning and maintenance.
- 21 CFR 211.68 Automatic, mechanical, and electronic equipment.
- 21 CFR 211.72 Filters.
- 21 CFR 211.80 General requirements.
- 21 CFR 211.82 Receipt and storage of untested components, drug product containers, and closures.
- 21 CFR 211.84 Testing and approval or rejection of components, drug product containers, and closures.
- 21 CFR 211.86 Use of approved components, drug product containers, and closures.
- 21 CFR 211.87 Retesting of approved components, drug product containers, and closures.
- 21 CFR 211.89 Rejected components, drug product containers, and closures.
- 21 CFR 211.94 Drug product containers and closures.
- 21 CFR 211.100 Written procedures; deviations.
- 21 CFR 211.101 Charge-in of components.
- 21 CFR 211.103 Calculation of yield.
- 21 CFR 211.105 Equipment identification.
- 21 CFR 211.110 Sampling and testing of in-process materials and drug products.
- 21 CFR 211.111 Time limitations on production.
- 21 CFR 211.113 Control of microbiological contamination.
- 21 CFR 211.115 Reprocessing.
- 21 CFR 211.122 Materials examination and usage criteria.
- 21 CFR 211.125 Labeling issuance.
- 21 CFR 211.130 Packaging and labeling operations.
- 21 CFR 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
- 21 CFR 211.134 Drug product inspection.
- 21 CFR 211.137 Expiration dating.
- 21 CFR 211.142 Warehousing procedures.
- 21 CFR 211.150 Distribution procedures.
- 21 CFR 211.160 General requirements.
- 21 CFR 211.165 Testing and release for distribution.
- 21 CFR 211.166 Stability testing.
- 21 CFR 211.167 Special testing requirements.
- 21 CFR 211.170 Reserve samples.
- 21 CFR 211.173 Laboratory animals.
- 21 CFR 211.176 Penicillin contamination.
- 21 CFR 211.180 General requirements.
- 21 CFR 211.182 Equipment cleaning and use log.
- 21 CFR 211.184 Component, drug product container, closure, and labeling records.
- 21 CFR 211.186 Master production and control records.
- 21 CFR 211.188 Batch production and control records.
- 21 CFR 211.192 Production record review.
- 21 CFR 211.194 Laboratory records.
- 21 CFR 211.196 Distribution records.
- 21 CFR 211.198 Complaint files.
- 21 CFR 211.204 Returned drug products.
- 21 CFR 211.208 Drug product salvaging.
