Validation and Qualification in Analytical Laboratories
2nd Edition
Published on 23. July 2007
288 pages
978-0-8493-8268-0 (ISBN)
Description
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
Reviews / Votes
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
More details
Edition
2nd edition
Language
English
Place of publication
Baton Rouge
United States
Publishing group
Taylor & Francis Inc
Target group
Professional and scholarly
Laboratory managers and analytical scientists in the pharmaceutical industry and testing laboratories; quality assurance managers and personnel; consultants, corporate training departments and reference librarians.
Edition type
Revised edition
Illustrations
48 s/w Abbildungen, 37 s/w Tabellen
48 b/w images and 37 tables
File size
3,51 MB
ISBN-13
978-0-8493-8268-0 (9780849382680)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
Book
07/2007
2nd Edition
CRC Press
€261.60
Shipment within 15-20 days
Content
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
