US FDA
21 CFR 211.87 - Retesting of Approved Components, Containers and Closures
Plain-language explanation, inspection context and common violation patterns.
What it says
Components, drug product containers and closures subject to deterioration must be retested or re-examined as appropriate for identity, strength, quality and purity, at appropriate intervals, to ensure suitability for use.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- Not every incoming material requires retesting - this obligation specifically applies to materials genuinely subject to deterioration over storage time, requiring a documented assessment of which materials fall into that category.
- Retest intervals must be scientifically justified for the specific material, based on its known stability characteristics, rather than a single blanket interval applied across all stored components.
- This is distinct from initial receipt testing under 211.84 - it governs materials that have been approved and are being held in inventory for a period before use.
What FDA inspectors look for
- Whether a documented assessment identifies which stored materials are subject to deterioration and therefore require a retest programme.
- Whether retest intervals have a scientific basis specific to each material, rather than being set arbitrarily or uniformly.
- Whether materials held beyond their established retest date are prevented from use until retesting is completed.
Most common violation
Stored components used in production after their established retest date without documented retesting, particularly for materials whose deterioration risk was not clearly assessed at the time of initial approval.
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