What the FDA Expects for Equipment Design, Size, and Location (Sect. 211.63) [Video]

The FDA expects that equipment used in the process of drug manufacturing and related activities be designed and well-suited for the location such that it enables cleaning, maintenance, and operations for its intended use.

Specifically, Section 211.63 states that:

“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.”

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP