Validation and Qualification in Analytical Laboratories

by Ludwig Huber

Overview

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

Product Details

ISBN-13:	9781040179369
Publisher:	CRC Press
Publication date:	07/23/2007
Sold by:	Barnes & Noble
Format:	eBook
Pages:	288
File size:	4 MB

Table of Contents

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

Editorial Reviews

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

From the Publisher