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Validation Standard Operating Procedures

A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech...

Syed Imtiaz Haider

$126

Paperback

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English
CRC Press
23 October 2019
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:  
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:  
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.

Haider, Syed Imtiaz

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