Practical Approaches to Method Validation and Essential Instrument Qualification

Description

Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirementsComplementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systemsPart 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance?coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers?and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labsAt the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.Content: Chapter 1 Overview of Risk?Based Approach to Phase Appropriate Validation and Instrument Qualification (pages 1–10): Chung Chow Chan, Herman Lam, Xue Ming Zhang, Stephan Jansen, Paul Larson, Charles T. Manfredi, William H. Wilson and Wolfgang WinterChapter 2 Phase Appropriate Method Validation (pages 11–25): Chung Chow Chan and Pramod SaraswatChapter 3 Analytical Method Verification, Method Revalidation, and Method Transfer (pages 27–43): Chung Chow Chan and Pramod SaraswatChapter 4 Validation of Process Analytical Technology Applications (pages 45–74): Alison C. E. HarringtonChapter 5 Validation of Near?Infrared Systems for Raw Material Identification (pages 75–91): Lenny DassChapter 6 Cleaning Validation (pages 93–110): Xue Ming Zhang, Chung Chow Chan and Anthony QuChapter 7 Risk?Based Validation of Laboratory Information Management Systems (pages 111–153): R. D. McDowallChapter 8 Performance Qualification and Verification of Balance (pages 155–175): Chung Chow Chan, Herman Lam, Arthur Reichmuth and Ian CiesniewskiChapter 9 Performance Verification of NIR Spectrophotometers (pages 177–199): Herman Lam and Shauna RotmanChapter 10 Operational Qualification in Practice for Gas Chromatography Instruments (pages 201–230): Wolfgang Winter, Stephan Jansen, Paul Larson, Charles T. Manfredi, William H. Wilson and Herman LamChapter 11 Performance Verification on Refractive Index, Fluorescence, and Evaporative Light?Scattering Detection (pages 231–253): Richard W. AndrewsChapter 12 Instrument Qualification and Performance Verification for Particle Size Instruments (pages 255–298): Alan F. RawleChapter 13 Method Validation, Qualification, and Performance Verification for Total Organic Carbon Analyzers (pages 299–325): Jose E. Martinez?RosaChapter 14 Instrument Performance Verification: Micropipettes (pages 327–346): George Rodrigues and Richard CurtisChapter 15 Instrument Qualification and Performance Verification for Automated Liquid?Handling Systems (pages 347–375): John Thomas Bradshaw and Keith J. AlbertChapter 16 Performance Qualification and Verification in Powder X?Ray Diffraction (pages 377–389): Aniceta Skowron