Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211&amp;showFR=1&gt;%3C/a%3E%3Ca
Timestamp: 2019-04-25 03:56:44+00:00

Document:
§ 211.22 - Responsibilities of quality control unit.
§ 211.25 - Personnel qualifications.
§ 211.28 - Personnel responsibilities.
§ 211.42 - Design and construction features.
§ 211.46 - Ventilation, air filtration, air heating and cooling.
§ 211.50 - Sewage and refuse.
§ 211.52 - Washing and toilet facilities.
§ 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.
§ 211.122 - 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.
Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264.
Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted.

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