Validating chromatographic methods a practical guide sex cavrljanje
For those experienced with method validation, the guide helps to upgrade and improve existing systems.Note: CD-ROM/DVD and other supplementary materials are not included as part of e Book file.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.
The book is also an excellent tool for training laboratory personnel in methods validation.
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.
It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations.
Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: * Method evaluation and further method development * Final method development and trial method validation * Formal method validation and report generation * Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided.
Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success.
BLIESNER, Ph D, is the founder and President of Delphi Analytical Services, Inc., an organization dedicated to improving clients' level of compliance with Current Good Manufacturing Practices, Quality System Regulations, and Current Good C...