All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation.
(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. Each chapter is visually pleasing, with bulleted lists to highlight important concerns and checklists to aid in evaluations.
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. Ng, Ph D 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. Audience: This book is directed at anyone in an analytical laboratory involved in validating assay or equipment performance.
All of the templates are also included on a CD-ROM, enabling readers to easily work with and customize them.
For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system.