Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical,...

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Syed Imtiaz Haider

Validation Standard Operating Procedures

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

Syed Imtiaz Haider

$546

Hardback

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English

CRC Press Inc
30 May 2006

Precision instruments manufacture

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 Inc
Country of Publication: United States
Edition: 2nd edition
Dimensions: Height: 234mm, Width: 156mm, Spine: 66mm
Weight: 1.610kg
ISBN: 9780849395291
ISBN 10: 0849395291
Pages: 1144
Publication Date: 30 May 2006
Audience: Professional and scholarly , College/higher education , Undergraduate , Further / Higher Education
Format: Hardback
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