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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 serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.
Editorials
From The Critics
Reviewer: Valerie L. Ng, PhD MD(Alameda County Medical Center/Highland Hospital)Description: This seemingly small 300-page book contains a wealth of information on validation and qualification of analytical methods and equipment.
Purpose: The purpose is to provide analytical laboratorians with a guide through validation and qualification processes to assure accurate, reliable, and consistent results. These worthy objectives are met.
Audience: This book is directed at anyone in an analytical laboratory involved in validating assay or equipment performance. Thus it would be useful to clinical laboratory scientists (students or practicing), pathologists, and doctoral or master's level scientists directing clinical laboratories. It would also be useful to other nonclinical laboratories performing analytical assays.
Features: The 17 chapters and five appendixes cover everything you might ever want to know about validation and "qualification" of assays and equipment in analytical laboratories. (The author is based in Germany, and I think "qualification" may be what we know as "verification" in the United States.) These chapters take the reader through the full gamut of considerations, including those related to regulatory requirements, risk management principles, equipment (including computer hardware and software), performance expectations, evaluating data and handling "out of specification" situations. The book is nicely written and easy to understand. Each chapter is visually pleasing, with bulleted lists to highlight important concerns and checklists to aid in evaluations. Each chapter clearly guides the reader through the processes — a blueprint for how to do what you need to do. Appendix B contains a nice listing of "operational qualifications" (or "instrument specifications" in U.S. lingo) for commonly used laboratory equipment — a list to keep handy. Of note is the fact that there is no mention or reference to similar documents and information from the U.S.-based Clinical and Laboratory Standards Institute (CLSI, formerly known as NCCLS). The information in this book is actually duplicative of that contained in relevant CLSI documents.
Assessment: This is a great single reference containing all you ever wanted to know about validating and verifying assay or equipment performance. One caveat: it duplicates CLSI documents, so you might not need it if you are a CLSI member organization.