21 CFR 조항별 지적사례

21 CFR 210.1 Status of current good manufacturing practice regulations. 문서 32건 21 CFR 211.100 Written procedures; deviations. 문서 197건 21 CFR 211.101 Charge-in of components. 문서 3건 21 CFR 211.110 Sampling and testing of in-process materials and drug products. 문서 9건 21 CFR 211.113 Control of microbiological contamination. 문서 92건 21 CFR 211.125 Labeling issuance. 문서 4건 21 CFR 211.130 Packaging and labeling operations. 문서 6건 21 CFR 211.137 Expiration dating. 문서 21건 21 CFR 211.142 Warehousing procedures. 문서 4건 21 CFR 211.160 General requirements. 문서 91건 21 CFR 211.165 Testing and release for distribution. 문서 148건 21 CFR 211.166 Stability testing. 문서 133건 21 CFR 211.167 Special testing requirements. 문서 7건 21 CFR 211.170 Reserve samples. 문서 4건 21 CFR 211.180 General requirements. 문서 32건 21 CFR 211.182 Equipment cleaning and use log. 문서 3건 21 CFR 211.186 Master production and control records. 문서 4건 21 CFR 211.188 Batch production and control records. 문서 63건 21 CFR 211.192 Production record review. 문서 136건 21 CFR 211.194 Laboratory records. 문서 30건 21 CFR 211.198 Complaint files. 문서 14건 21 CFR 211.22 Responsibilities of quality control unit. 문서 189건 21 CFR 211.25 Personnel qualifications. 문서 20건 21 CFR 211.28 Personnel responsibilities. 문서 5건 21 CFR 211.34 Consultants. 문서 221건 21 CFR 211.42 Design and construction features. 문서 81건 21 CFR 211.56 Sanitation. 문서 8건 21 CFR 211.58 Maintenance. 문서 10건 21 CFR 211.63 Equipment design, size, and location. 문서 16건 21 CFR 211.67 Equipment cleaning and maintenance. 문서 77건 21 CFR 211.68 Automatic, mechanical, and electronic equipment. 문서 33건 21 CFR 211.80 General requirements. 문서 4건 21 CFR 211.84 Testing and approval or rejection of components, drug product containers, and closures. 문서 185건 21 CFR 211.94 Drug product containers and closures. 문서 3건