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. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. 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. 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. 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 eBook file.
Product Identifiers
Publisher
John Wiley & Sons Inc
ISBN-13
9780471741473
eBay Product ID (ePID)
96555461
Product Key Features
Author
David M. Bliesner
Publication Name
Validating Chromatographic Methods: a Practical Guide
Format
Hardcover
Language
English
Subject
Chemistry
Publication Year
2006
Type
Textbook
Number of Pages
304 Pages
Dimensions
Item Height
237mm
Item Width
165mm
Item Weight
562g
Additional Product Features
Title_Author
David M. Bliesner
Country/Region of Manufacture
United States
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