Production and Process Controls

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs: General
  6. Current Good Manufacturing Practice for Finished Pharmaceuticals
  7. Production and Process Controls

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Section
211.100

Written procedures; deviations.

Section
211.101

Charge-in of components.

Section
211.103

Calculation of yield.

Section
211.105

Equipment identification.

Section
211.110

Sampling and testing of in-process materials and drug products.

Section
211.111

Time limitations on production.

Section
211.113

Control of microbiological contamination.

Section
211.115

Reprocessing.