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Appendix II: Template for An Example Methods Validation Standard Operating Procedure (SOP) by Bliesner, David M. is a scholarly article available to read on EtoBox.

What is Appendix II: Template for An Example Methods Validation Standard Operating Procedure (SOP) about?

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

Author

Bliesner, David M.

Publisher

John Wiley & Sons, Incorporated

Published

2006

Language

EN

ISBN

9780471741473