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.

All manufacturing companies face the daunting task of designing an employee training matrix that meets the gamut of national and international regulatory standards. Answering the call for a one-stop training resource that focuses exclusively on this multi-faceted, high-tech industry, Biotechnology: A Comprehensive Training Guide for the Biotechnology Industry provides ready-to-implement training templates that save time and expense without cutting corners on critical elements.

Attached CD-ROM: Why Reinvent the Wheel?

This complete,...

A valuable tool for chemists and analysts working in Quality Control laboratories, this book provides technical solutions that fulfill training requirements and build skilled manpower. The text is written for practitioners in quality control laboratories, product development laboratories, and stability laboratories in pharmaceutical and bio-pharmaceutical manufacturing, along with students in pharmaceutical and biotechnology development. It includes chapters on various elements commonly used in quality control labs, with questions at the end to ensure understanding. It also includes training...