§ 211.80 General requirements.
(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures; such written procedures shall be followed.
(b) Components and drug product containers and closures shall at all times be handled and stored in a manner to prevent contamination.
(c) Bagged or boxed components of drug product containers, or closures shall be stored off the floor and suitably spaced to permit cleaning and inspection.
(d) Each container or grouping of containers for components or drug product containers, or closures shall be identified with a distinctive code for each lot in each shipment received. This code shall be used in recording the disposition of each lot. Each lot shall be appropriately identified as to its status (i.e., quarantined, approved, or rejected).
How BatchGlow handles this
Each received container is registered with its own ID and QR label and linked to its lot; staging and weighing check the lot's status for every container they scan.
What it asks for, in plain words
- 21 CFR 211.80
- Written procedures, followed in practice, cover the receipt, identification, storage, handling, sampling, testing and approval or rejection of components, containers and closures, which are handled and stored so as to prevent contamination. Each container or group of containers of a lot in each shipment carries a distinctive code, used to record the lot's disposition, and each lot is identified by its status: quarantined, approved or rejected.
These summaries are BatchGlow's reading of the text on this page, checked against it on 5 Oct 2026. The text governs.