Author Chan, Chung Chow
Title Practical Approaches to Method Validation and Essential Instrument Qualification
Imprint Hoboken : Wiley, 2010
©2010
book jacket
Edition 1st ed
Descript 1 online resource (415 pages)
text txt rdacontent
computer c rdamedia
online resource cr rdacarrier
Note Intro -- PRACTICAL APPROACHES TO METHOD VALIDATION AND ESSENTIAL INSTRUMENT QUALIFICATION -- CONTENTS -- Contributors -- Preface -- 1 Overview of Risk-Based Approach to Phase Appropriate Validation and Instrument Qualification -- 1 Risk-Based Approach to Pharmaceutical Development -- 2 Regulatory Requirements for Performance Verification of Instruments -- 3 General Approach to Instrument Performance Qualification -- References -- 2 Phase Appropriate Method Validation -- 1 Introduction -- 2 Parameters for Qualification and Validation -- 3 Qualification and Validation Practices -- 4 Common Problems and Solutions -- References -- 3 Analytical Method Verification, Method Revalidation, and Method Transfer -- 1 Introduction -- 2 Cycle of Analytical Methods -- 3 Method Verification Practices -- 4 Method Revalidation -- 5 Method Transfer -- 6 Common Problems and Solutions -- References -- 4 Validation of Process Analytical Technology Applications -- 1 Introduction -- 2 Parameters for Qualification and Validation -- 3 Qualification, Validation, and Verification Practices -- 4 Common Problems and Solutions -- References -- 5 Validation of Near-Infrared Systems for Raw Material Identification -- 1 Introduction -- 2 Validation of an NIR System -- 3 Validation Plan -- References -- 6 Cleaning Validation -- 1 Introduction -- 2 Scope of the Chapter -- 3 Strategies and Validation Parameters -- 4 Analytical Methods in Cleaning Validation -- 5 Sampling Techniques -- 6 Acceptance Criteria of Limits -- 7 Campaign Cleaning Validation -- 8 Common Problems and Solutions -- References -- 7 Risk-Based Validation of Laboratory Information Management Systems -- 1 Introduction -- 2 LIMS and the LIMS Environment -- 3 Understanding and Simplifying Laboratory Processes -- 4 GAMP Software Categories and System Life Cycle for a LIMS
5 Validation Roles and Responsibilities for a LIMS Project -- 6 System Life-Cycle Detail and Documented Evidence -- 7 Maintaining the Validated Status -- 8 Summary -- References -- 8 Performance Qualification and Verification of Balance -- 1 Introduction -- 2 Performance Qualification -- 3 Common Problems and Solutions -- References -- Appendix -- 9 Performance Verification of NIR Spectrophotometers -- 1 Introduction -- 2 Performance Attributes -- 3 Practical Tips in NIR Performance Verification -- References -- Appendix 1 -- Appendix 2 -- 10 Operational Qualification in Practice for Gas Chromatography Instruments -- 1 Introduction -- 2 Parameters for Qualification -- 3 Operational Qualification -- 4 Preventive Maintenance -- 5 Common Problems and Solutions -- References -- 11 Performance Verification on Refractive Index, Fluorescence, and Evaporative Light-Scattering Detection -- 1 Introduction -- 2 Qualification of Differential Refractive Index Detectors -- 3 Qualification of Fluorescence Detectors -- 4 Qualification of Evaporative Light-Scattering Detectors -- Reference -- 12 Instrument Qualification and Performance Verification for Particle Size Instruments -- 1 Introduction -- 2 Setting the Scene -- 3 Particle Counting Techniques -- 4 Particle Size Analysis and Distribution -- 5 Instrument Qualification for Particle Size -- 6 Qualification of Instruments Used in Particle Sizing -- 7 Method Development -- 8 Verification: Particle Size Distribution Checklist -- 9 Common Problems and Solutions -- 10 Conclusions -- References -- Appendix -- 13 Method Validation, Qualification, and Performance Verification for Total Organic Carbon Analyzers -- 1 Introduction -- 2 TOC Methodologies -- 3 Parameters for Method Validation, Qualification, and Verification -- 4 Qualification, Validation, and Verification Practices -- 5 Common Problems and Solutions
References -- 14 Instrument Performance Verification: Micropipettes -- 1 Introduction -- 2 Scope of the Chapter -- 3 Verification Practices: Volume Settings, Number of Replicates, and Tips -- 4 Parameters: Accuracy, Precision, and Uncertainty -- 5 Summary -- References -- 15 Instrument Qualification and Performance Verification for Automated Liquid-Handling Systems -- 1 Introduction -- 2 Commonalities Between Volume Verification Methods for Performance Evaluation -- 3 Volume Verification Methods -- 4 Importance of Standardization -- 5 Summary -- References -- 16 Performance Qualification and Verification in Powder X-Ray Diffraction -- 1 Introduction -- 2 Basics of X-Ray Diffraction -- 3 Performance Qualification -- 4 Performance Verification: Calibration Practice -- References -- Index
Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing 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 systems Part 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 labs At 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
Description based on publisher supplied metadata and other sources
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2020. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries
Link Print version: Chan, Chung Chow Practical Approaches to Method Validation and Essential Instrument Qualification Hoboken : Wiley,c2010 9780470121948
Subject Drugs -- Analysis -- Methodology -- Evaluation.;Laboratories -- Equipment and supplies -- Evaluation.;Laboratories -- Instruments -- Evaluation.;Electronic books
Electronic books
Alt Author Lam, Herman
Zhang, Xue-Ming