§ 211.63 Equipment design, size, and location.
Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.
How BatchGlow handles this
A batch is planned only within the minimum and maximum working volume of the vessel it will be made in.
What it asks for, in plain words
- 21 CFR 211.63
- Equipment used to make, process, pack or hold a drug is of appropriate design and adequate size, and is placed so that it can be used, cleaned and maintained as intended.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.