21CFR PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart A - General Provisions

§ 211.1 - Scope.

§ 211.3 - Definitions.


Subpart B - Organization and Personnel

§ 211.22 - Responsibilities of quality control unit.

§ 211.25 - Personnel qualifications.

§ 211.28 - Personnel responsibilities.

§ 211.34 - Consultants.


Subpart C - Buildings and Facilities

§ 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.


Subpart D - Equipment

§ 211.63 - Equipment design, size, and location.

§ 211.65 - Equipment construction.

§ 211.67 - Equipment cleaning and maintenance.

§ 211.68 - Automatic, mechanical, and electronic equipment.

§ 211.72 - Filters.


Subpart E - Control of Components and Drug Product Containers and Closures

§ 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.


Subpart F - Production and Process Controls

§ 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.


Subpart G - Packaging and Labeling Control

§ 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.


Subpart H - Holding and Distribution

§ 211.142 - Warehousing procedures.

§ 211.150 - Distribution procedures.


Subpart I - Laboratory Controls

§ 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.


Subpart J - Records and Reports

§ 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


Subpart K - Returned and Salvaged Drug Products

§ 211.204 Returned drug products

§ 211.208 Drug product salvaging