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

ISBN-13: 9780849395291 / Angielski / Twarda / 2006 / 1144 str.

Syed Imtiaz Haider

Opis

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.

Spis treści

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.

O autorze

Haider, Syed Imtiaz