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

By Syed Imtiaz Haider

Book Overview

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.

• Format: Hardcover
• Language: English
• ISBN: 0849395291
• ISBN13: 9780849395291
• Release Date: May 2006
• Publisher: CRC Press
• Length: 1144 Pages
• Weight: 3.80 lbs.
• Dimensions: 2.6" x 6.4" x 9.3"