§ 211.87 Retesting of approved components, drug product containers, and closures.
Components, drug product containers, and closures shall be retested or reexamined, as appropriate, for identity, strength, quality, and purity and approved or rejected by the quality control unit in accordance with § 211.84 as necessary, e.g., after storage for long periods or after exposure to air, heat or other conditions that might adversely affect the component, drug product container, or closure.
How BatchGlow handles this
Every time a container is staged or weighed, its lot is checked again: QC-accepted, not past its expiry date, and not on a recall, stability or OOS hold.
What it asks for, in plain words
- 21 CFR 211.87
- Approved components, containers and closures are retested or reexamined and approved or rejected by the quality control unit as necessary, for example after long storage or exposure to air, heat or other harmful conditions.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.