CFR - Code of Federal Regulations Title 21

§ 211.1 - Scope. § 211.3 - Definitions.

§ 211.22 - Responsibilities of quality control unit. § 211.25 - Personnel qualifications. § 211.28 - Personnel responsibilities. § 211.34 - Consultants.

§ 211.42 - Design and construction features. § 211.44 - Lighting. § 211.46 - Ventilation, air filtration, air heating and cooling. § 211.48 - Plumbing. § 211.50 - Sewage and refuse. § 211.52 - Washing and toilet facilities. § 211.56 - Sanitation. § 211.58 - Maintenance.

§ 211.63 - Equipment design, size, and location. § 211.65 - Equipment construction. § 211.67 - Equipment cleaning and maintenance. § 211.68 - Automatic, mechanical, and electronic equipment.

§ 211.80 - General requirements. § 211.82 - Receipt and storage of untested components, drug product containers, and closures. § 211.84 - Testing and approval or rejection of components, drug product containers, and closures. § 211.86 - Use of approved components, drug product containers, and closures. § 211.87 - Retesting of approved components, drug product containers, and closures. § 211.89 - Rejected components, drug product containers, and closures. § 211.94 - Drug product containers and closures.

§ 211.100 - Written procedures; deviations. § 211.101 - Charge-in of components. § 211.103 - Calculation of yield. § 211.105 - Equipment identification. § 211.110 - Sampling and testing of in-process materials and drug products. § 211.111 - Time limitations on production. § 211.113 - Control of microbiological contamination. § 211.115 - Reprocessing.

§ 211.122 - Materials examination and usage criteria. § 211.125 - Labeling issuance. § 211.130 - Packaging and labeling operations. § 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. § 211.134 - Drug product inspection. § 211.137 - Expiration dating.

§ 211.142 - Warehousing procedures. § 211.150 - Distribution procedures.

§ 211.160 - General requirements. § 211.165 - Testing and release for distribution. § 211.166 - Stability testing. § 211.167 - Special testing requirements. § 211.170 - Reserve samples. § 211.173 - Laboratory animals. § 211.176 - Penicillin contamination.

§ 211.180 - General requirements. § 211.182 - Equipment cleaning and use log. § 211.184 - Component, drug product container, closure, and labeling records. § 211.186 - Master production and control records. § 211.188 - Batch production and control records. § 211.192 - Production record review. § 211.194 - Laboratory records. § 211.196 - Distribution records. § 211.198 - Complaint files.

§ 211.204 - Returned drug products. § 211.208 - Drug product salvaging.