Title 21

PART 211 SUBPART F

Subpart F - Production and Process Controls

• 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264.
• 43 FR 45077, Sept. 29, 1978, unless otherwise noted.

21:4.0.1.1.11.6.1.1	SECTION 211.100	211.100 Written procedures; deviations.
21:4.0.1.1.11.6.1.2	SECTION 211.101	211.101 Charge-in of components.
21:4.0.1.1.11.6.1.3	SECTION 211.103	211.103 Calculation of yield.
21:4.0.1.1.11.6.1.4	SECTION 211.105	211.105 Equipment identification.
21:4.0.1.1.11.6.1.5	SECTION 211.110	211.110 Sampling and testing of in-process materials and drug products.
21:4.0.1.1.11.6.1.6	SECTION 211.111	211.111 Time limitations on production.
21:4.0.1.1.11.6.1.7	SECTION 211.113	211.113 Control of microbiological contamination.
21:4.0.1.1.11.6.1.8	SECTION 211.115	211.115 Reprocessing.

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