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Practical Approaches to Method Validation and Essential Instrument Qualification by Chung Chow Chan, Herman Lam, Xue-Ming Zhang (Hardcover, 2010)

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Product Information

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.

Product Identifiers

Publisher
John Wiley & Sons Inc
ISBN-13
9780470121948
eBay Product ID (ePID)
94768762

Product Key Features

Author
Chung Chow Chan, Herman Lam, Xue-Ming Zhang
Publication Name
Practical Approaches to Method Validation and Essential Instrument Qualification
Format
Hardcover
Language
English
Subject
Chemistry, Science
Publication Year
2010
Type
Textbook
Number of Pages
416 Pages

Dimensions

Item Height
246mm
Item Width
169mm
Item Weight
726g

Additional Product Features

Title_Author
Herman Lam, Chung Chow Chan, Xue-Ming Zhang
Country/Region of Manufacture
United States

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Practical Approaches to Method Validation and Essential Instrument Qualification by Chung Chow Chan, Herman Lam, Xue-Ming Zhang (Hardcover, 2010)

About this product

Product Information

Product Identifiers

Product Key Features

Dimensions

Additional Product Features

Best Selling in School Textbooks & Study Guides

Tracks, Scats and Other Traces: Reissue by Barbara Triggs (Paperback, 2004)

Save on School Textbooks & Study Guides

Excel Success One HSC Mathematics Extension 1 2024 Edition

Powerless: Tiktok Made Me Buy It! an Epic and Sizzling Fantasy Romance Not

Targeting Mental Maths Australian Curriculum Year 5 - New Edition 2023

Medication Log Book: Simple Personal Medication Administration Planner & Record

Bindi: Winner of the Daisy Utemorrah Award by Kirli Saunders (Paperback) FREE Sh

The Meateater Fish and Game Cookbook: Recipes and Techniques for Every Hunter an

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