Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.
- ISBN10 0367390779
- ISBN13 9780367390778
- Publish Date 23 October 2019 (first published 27 December 2001)
- Publish Status Active
- Publish Country GB
- Publisher Taylor & Francis Ltd
- Imprint CRC Press
- Edition 2nd edition
- Format Paperback
- Pages 1144
- Language English