Practical Approaches to Method Validation and Essential Instrument Qualification (Hardcover)

Langue : anglais

Edité par John Wiley & Sons Inc, New York, 2010

0470121947 / 9780470121948

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Hardcover. 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 performancecoverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzersand 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. All regulated laboratories, including pharmaceutical, clinical testing, food and cosmetic laboratories, must properly execute the calibration of instruments and validation of analytical methods. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability. …

N° de réf. du vendeur 9780470121948

Titre
Practical Approaches to Method Validation and Essential Instrument Qualification (Hardcover)
Auteur
Chung Chow Chan
Éditeur
John Wiley & Sons Inc, New York
Année de publication
2010
État de l'article
new
Reliure
Hardcover
Langue
anglais
ISBN à 10 chiffres
0470121947
ISBN à 13 chiffres
9780470121948
Édition
Edition originale

CitiRetail

Stevenage, Royaume-Uni

Vendeur avec une évaluation de 5 étoiles

Vendeur AbeBooks depuis 29 juin 2022

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