What Current Good Manufacturing Practice for Finished Pharmaceuticals requires
This regulation, specifically 21 CFR 211.22, requires pharmaceutical manufacturers to establish and follow written procedures for quality control, and applies to all finished pharmaceuticals, as stated in 21 CFR 210.1.
Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration · Version: 1.0.1 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210
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Primary Citations — 5 traced to source
- 21 CFR 210.1: Status of Current Good Manufacturing Practice Regulations
- 21 CFR 211.22: Responsibilities of Quality Control Unit
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