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
developmentFinal method development and trial method
validationFormal method validation and report generationFormal 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.
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