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An Easy to Understand Guide to HPLC Validation
High Performance Liquid Chromatography (HPLC) is one of the most widely used techniques in the modern analytical laboratory. The specificity, sensitivity and of HPLC make it readily applicable to the determination of a wide range of analytes in an enormous range of sample matrices.
Analytical laboratories must be able to demonstrate a high level of assurance that any instruments used in the laboratory to create analytical data are suitable for that purpose and will consistently produce results that conform to appropriate quality standards.
This book describes, with examples, the entire process, from establishing specifications through selection of instrument and supplier to installing, testing and maintaining the HPLC and finally decommissioning instrument, of creating the documented evidence needed to demonstrate a high level of confidence that the HPLC will consistently perform to appropriate quality criteria.
The book employs an underlying case study approach where example extracts from the various documents are presented to illustrate the requirements.
An Easy to Understand Guide to HPLC Validation is published by Learn About GMP and is available online at: