Validating Chromatographic Methods

All the information and tools needed to set up a successfulmethod validation system
Validating Chromatographic Methods brings order andCurrent Good Manufacturing Practices to the often chaotic processof chromatographic method validation. It provides readers with boththe practical information and the tools necessary to successfullyset up a new validation system or upgrade a current system to fullycomply with government safety and quality regulations. The netresults are validated and transferable analytical methods that willserve for extended periods of time with minimal or nocomplications.
This guide focuses on high-performance liquid chromatographicmethods validation; however, the concepts are generally applicableto the validation of other analytical techniques as well. Followingan overview of analytical method validation and a discussion of itsvarious components, the author dedicates a complete chapter to eachstep 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 OperatingProcedures, Standard Test Methods, Methods Validation Protocols,and Methods Validation Reports are all provided. Moreover, theguide features detailed flowcharts and checklists that lead readersthrough every stage of method validation to ensure success. All ofthe templates are also included on a CD-ROM, enabling readers toeasily work with and customize them.
For scientists and technicians new to method validation, thisguide provides all the information and tools needed to develop atop-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 arenot included as part of eBook file.