Validation and Qualification in Analytical Laboratories

ISBN-13: 9780849382673 / Angielski / Twarda / 2007 / 288 str.

Ludwig Huber

Opis

This complete guide and reference explains how to improve product quality while achieving compliance with the world's regulatory standards. It shows how to develop and implement a validation strategy for routine, nonroutine, and standard analytical methods encompassing the entire equipment hardware and software qualification process. It includes examples and templates to help readers through the validation process. In addition to guidelines on the qualification of standards, certified and in-house reference materials, and employee qualification, it covers internal and third-party lab audits and inspections.

Recenzje

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

Spis treści

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

O autorze

Ludwig Huber