Validation Standard Operating Procedures

A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries
2. New Auflage 2006
ISBN: 978-0-8493-9529-1
Verlag: Taylor & Francis Inc

Buch, Englisch, 1144 Seiten, Format (B × H): 161 mm x 238 mm, Gewicht: 1723 g

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.

Zielgruppe

Academic and Professional Practice & Development

Autoren/Hrsg.

Haider, Syed Imtiaz

Fachgebiete

• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie

Inhaltsverzeichnis

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.

Über Autor(innen)

Haider, Syed Imtiaz