What US 21 CFR Part 210: Current Good Manufacturing Practice in Manufacturing Processing Packing or Holding of Drugs - General requires
US 21 CFR Part 210 establishes the general provisions and definitions for current good manufacturing practice (cGMP) regulations under the Federal Food Drug and Cosmetic Act. The regulation defines key terms (active ingredient, batch, component, drug product, lot, manufacture, quality control unit) and the scope of cGMP application to manufacturing, processing, packing, or holding of drugs. It cross-references Part 211 (finished pharmaceuticals), Part 212 (PET drugs), and Part 226 (medicated articles). Compliance is foundational to FDA drug manufacturing and is verified during routine inspections.
Pillar: Pharmaceuticals & Life Sciences · Authority: US Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210
SHA-256 integrity: 8f084e9d101cc41b58e225ac049277bc95729098dee00f31057e8f4b2b2bb468
Primary Citations — 5 traced to source
- Title 21 Code of Federal Regulations Part 210 General Provisions for cGMP
- Title 21 Code of Federal Regulations Part 211 cGMP for Finished Pharmaceuticals
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