1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter C - DRUGS: GENERAL
  5. Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
  6. Subpart F - Production and Process Controls
  7. 21 CFR § 211.111
21 CFR § 211.111
Time limitations on production
June 25, 2020
CFR

When appropriate, time limits for the completion of each phase of production shall be established to assure the quality of the drug product. Deviation from established time limits may be acceptable if such deviation does not compromise the quality of the drug product. Such deviation shall be justified and documented.

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§ 211.110 Sampling and testing of in-process materials and drug products
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§ 211.113 Control of microbiological contamination

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