US FDA
21 CFR 211.84 - Testing and Approval or Rejection of Components
Plain-language explanation, inspection context and common violation patterns.
What it says
Each lot of components, drug product containers and closures must be tested or otherwise verified against appropriate specifications before use, and reliance on a supplier's certificate of analysis in place of full testing is permitted only after the reliability of that supplier's analyses has been established through appropriate validation.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- Initial use of any new supplier requires full analytical testing of the material, regardless of the supplier's own certificate of analysis - reduced testing is a privilege earned through demonstrated reliability, not a default.
- For active pharmaceutical ingredients specifically, at least one specific identity test must be conducted on each lot received, regardless of supplier qualification status.
- Establishing supplier reliability requires a documented comparative testing programme over time, not a single successful shipment.
What FDA inspectors look for
- Whether reduced testing against a supplier's certificate of analysis is supported by documented validation of that specific supplier's reliability, not applied as a blanket default.
- Whether identity testing is performed on every lot of active pharmaceutical ingredient received, even from long-qualified suppliers.
- Whether the supplier qualification and material testing programmes are actually connected, rather than existing as separate, disconnected systems.
Most common violation
Relying on a supplier's certificate of analysis for release testing without documented evidence the supplier's analytical reliability was ever formally validated, or skipping identity testing on incoming active pharmaceutical ingredient lots based on a strong supplier audit history alone.
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