V5 Ultimate
Compliance

21 CFR 210

cGMP in Manufacturing, Processing, Packing, or Holding of Drugs — General

TL;DR

FDA's umbrella cGMP regulation for drug products — sets scope, definitions and the regulatory status of Part 211.

21 CFR Part 210 establishes that the regulations in Parts 210, 211, 225 and 226 contain the minimum current Good Manufacturing Practice for the preparation of drug products. It is the legal hook FDA uses to enforce cGMP on any drug, API or in-process material — a product not made under cGMP is deemed adulterated under section 501(a)(2)(B) of the FD&C Act.

In practice teams cite Part 211 (the detailed cGMP requirements) far more often than 210 itself, but 210 sets the definitions (batch, lot, component, drug product, representative sample) and is what gives 211 teeth.

Regulatory anchors
  • 21 CFR Part 210
Industries that live with this
PharmaceuticalRadiopharma
How V5 handles it
eBMR / eDHR — the batch record writes itself.
When the master is locked and the operator works on the kiosk, the batch record is no longer something to assemble — it’s something to render.
21 CFR Part 11 — the operating model, not a checkbox.
Other systems bolt Part 11 on top. V5 enforces it at the database layer so application code can never rewrite history.
Related terms
21 CFR 21121 CFR 212GxPICH Q721 CFR Part 1121 CFR 58ICH Q9ICH Q10ICH Q2ICH Q6QP releaseConditional releaseDeviationOOSOOTCAPANCRLine ClearanceTech Transfer
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