This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards.

Principles and Practices of Method Validation is an overview of the most recent approaches used for method validation in cases when a large number of analytes are determined from a single aliquot and where a large number of samples are to be analysed.

A Guide to Best Practice - Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests.

Analytical Method Validation and Instrument Performance Verification provides a uniquely practical approach to method validation and instrument performance verification.

Validation is a broad concept in the pharmaceutical manufacturing industry. It includes process validation, analytical method validation, equipment validation, cleaning validation and system validation.