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.
By:
Syed Imtiaz Haider Imprint: CRC Press Country of Publication: United Kingdom Edition: 2nd edition Dimensions:
Height: 234mm,
Width: 156mm,
Weight: 1.610kg ISBN:9780367390778 ISBN 10: 0367390779 Pages: 1144 Publication Date:23 October 2019 Audience:
Professional and scholarly
,
Undergraduate
Format:Paperback Publisher's Status: Active
Introduction to Validation. Fundamentals of Validation SOPs. Validation Glossary. Calibration of Instruments. Training on the Job. Guidelines for Area Classification and Air Handling. Validation of a Steam Sterilizer. Kneading Machine. Blistering Machine. Installation Qualification of Computerized Equipment. Validation of Microbiological Methods. Vendor Certification. Facility Qualification. Recommended Reading.