Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs — General
Establishes the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the Act.
All drug manufacturers for human and veterinary use. Part 210 provides definitions and applicability scope; Part 211 provides the operational requirements.
- 01Defines the threshold for what constitutes GMP applicability
- 02Establishes that failure to comply constitutes adulteration under 21 U.S.C. 351(a)(2)(B)
- 03Provides definitions for all key terms used throughout Part 211
- 04Clarifies that the regulations in Part 211 are minimum standards
Part of the 2023 harmonisation update alongside Part 211. Definitions clarified.
21 CFR Part 210: frequently asked questions
Quick answers to common questions about 21 CFR Part 210.
What is 21 CFR Part 210?
21 CFR Part 210 — Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs — General — is a regulation issued by the Food and Drug Administration (United States). Establishes the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the Act.
Who does 21 CFR Part 210 apply to?
All drug manufacturers for human and veterinary use. Part 210 provides definitions and applicability scope; Part 211 provides the operational requirements.
What are the key requirements of 21 CFR Part 210?
FDA 21 CFR Part 210 requires, among other things: Defines the threshold for what constitutes GMP applicability; Establishes that failure to comply constitutes adulteration under 21 U.S.C. 351(a)(2)(B); Provides definitions for all key terms used throughout Part 211; Clarifies that the regulations in Part 211 are minimum standards.
When was 21 CFR Part 210 last updated?
The current version of 21 CFR Part 210 dates from April 2023. Part of the 2023 harmonisation update alongside Part 211. Definitions clarified.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When 21 CFR Part 210 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.