§ 211.82 Receipt and storage of untested components, drug product containers, and closures.
(a) Upon receipt and before acceptance, each container or grouping of containers of components, drug product containers, and closures shall be examined visually for appropriate labeling as to contents, container damage or broken seals, and contamination.
(b) Components, drug product containers, and closures shall be stored under quarantine until they have been tested or examined, whichever is appropriate, and released. Storage within the area shall conform to the requirements of § 211.80.
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]
How BatchGlow handles this
A container is staged for production only when it is available and its lot is QC-accepted; until then it cannot be picked.
What it asks for, in plain words
- 21 CFR 211.82
- On receipt and before acceptance, each container of components, drug product containers and closures is examined for correct labeling, damage, broken seals and contamination. The material stays in quarantine until it has been tested or examined and released.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.