2nd Edition

Validation Standard Operating Procedures A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries

By Syed Imtiaz Haider Copyright 2006
    1144 Pages
    by CRC Press

    1144 Pages 16 B/W Illustrations
    by CRC Press

    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.

    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