Practical Approaches to Method Validation and Essential Instrument Qualification

Practical approaches to ensure that analytical methods andinstruments meet GMP standards and requirements Complementing the authors' first book, Analytical MethodValidation and Instrument Performance Verification, this new volumeprovides coverage of more advanced topics, focusing on additionaland supplemental methods, instruments, and electronic systems thatare used in pharmaceutical, biopharmaceutical, and clinicaltesting. Readers will gain new and valuable insights that enablethem to avoid common pitfalls in order to seamlessly conductanalytical method validation as well as instrument operationqualification and performance verification. * Part 1, Method Validation, begins with an overview of the book'srisk-based approach to phase appropriate validation and instrumentqualification; it then focuses on the strategies and requirementsfor early phase drug development, including validation of specifictechniques and functions such as process analytical technology,cleaning validation, and validation of laboratory informationmanagement systems * Part 2, Instrument Performance Verification, explores theunderlying principles and techniques for verifying instrumentperformance--coverage includes analytical instruments that areincreasingly important to the pharmaceutical industry, such as NIRspectrometers and particle size analyzers--and offers readers avariety of alternative approaches for the successful verificationof instrument performance based on the needs of their labs At the end of each chapter, the authors examine importantpractical problems and share their solutions. All the methodscovered in this book follow Good Analytical Practices (GAP) toensure that reliable data are generated in compliance with currentGood Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technicalmanagers should turn to this book to ensure that analytical methodsand instruments are accurate and meet GMP standards andrequirements.