§ 211.105 Equipment identification.
(a) All compounding and storage containers, processing lines, and major equipment used during the production of a batch of a drug product shall be properly identified at all times to indicate their contents and, when necessary, the phase of processing of the batch.
(b) Major equipment shall be identified by a distinctive identification number or code that shall be recorded in the batch production record to show the specific equipment used in the manufacture of each batch of a drug product. In cases where only one of a particular type of equipment exists in a manufacturing facility, the name of the equipment may be used in lieu of a distinctive identification number or code.
How BatchGlow handles this
Every bulk vessel is registered equipment with its own code. It is scanned when bulk is posted, binding the batch to that vessel, and a vessel in quarantine cannot be charged.
What it asks for, in plain words
- 21 CFR 211.105
- Containers, lines and major equipment used for a batch are identified at all times with their contents and, where necessary, the phase of processing. Major equipment has a distinct number or code that is recorded in the batch record.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.