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Book Cover
E-book
Author Chan, Chung Chow

Title Practical Approaches to Method Validation and Essential Instrument Qualification
Published Hoboken : John Wiley & Sons, 2011

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Description 1 online resource (722 pages)
Contents Cover; Title Page; Copyright Page; Preface; Contributors; Chapter 1: Overview of Risk-Based Approach to Phase Appropriate Validation and Instrument Qualification; Chapter 2: Phase Appropriate Method Validation; Chapter 3: Analytical Method Verification, Method Revalidation, and Method Transfer; Chapter 4: Validation of Process Analytical Technology Applications; Chapter 5: Validation of Near-Infrared Systems for Raw Material Identification; Chapter 6: Cleaning Validation; Chapter 7: Risk-Based Validation of Laboratory Information Management Systems
Chapter 8: Performance Qualification and Verification of BalanceChapter 9: Performance Verification of NIR Spectrophotometers; Chapter 10: OPERATIONAL QUALIFICATION IN PRACTICE FOR GAS CHROMATOGRAPHY INSTRUMENTS; Chapter 11: Performance Verification on Refractive Index, Fluorescence, and Evaporative Light-Scattering Detection; Chapter 12: Instrument qualification and performance verification for particle size instruments; Chapter 13: Method Validation, Qualification, and Performance Verification for Total Organic Carbon Analyzers; Chapter 14: Instrument Performance Verification: MicroPipettes
Chapter 15: Instrument Qualification and Performance Verification for Automated Liquid-Handling SystemsChapter 16: Performance Qualification and Verification in Powder X-Ray Diffraction; Index
Summary 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
Notes Print version record
Subject Drugs -- Analysis -- Methodology -- Evaluation
Laboratories -- Equipment and supplies -- Evaluation
Laboratories -- Instruments -- Evaluation
SCIENCE -- Chemistry -- Analytic.
Science
Form Electronic book
Author Lam, Herman
Zhang, Xue-Ming
ISBN 9781118060315
1118060318
9780470630716
047063071X
9780470630709
0470630701