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Bibliographic Details

Title: Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries
Publisher: CRC Press
Publication Date: 2006
Language: English
ISBN 10: 0849395291
ISBN 13: 9780849395291
Binding: Hardcover
Edition: 2nd Edition
Condition: Good

About this title

Synopsis

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.