314 Pages
48 B/W Illustrations
by
CRC Press
288 Pages
by
CRC Press
Also available as eBook on:
This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains... Read more
Regulations. Terminology. Risk Assessment. Master and Project Planning. Design Qualification. Installation Qualification. Operational Qualification. Performance Qualification. Software and Computers. Validation. Data Review. Out-of-Specifications. Certified Reference Standards. People. Proficiency Testing. Audits. Appendix A: Glossary. Appendix B: Testing. Appendix C: SOP. Appendix D: Books. Appendix E: References
Biography
Ludwig Huber
a great single reference containing all you ever wanted to know about validating and verifying assay or equipment performance.
Doody’s Review - Valerie L. Ng, PhD, MD
