Analytical Method Validation and Instrument Performance Verification

Beschreibung

Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.

Autor*in

Chung Chow Chan

Themen in »Analytical Method Validation and Instrument Performance Verification«

Analytical Chemistry Analytische Chemie Chemie Chemistry Pharmaceutical & Medicinal Chemistry Pharmazeutische u. Medizinische Chemie

Stimmen zu »Analytical Method Validation and Instrument Performance Verification«

"It is a treasure of helpful hints and techniques which canaid even experienced analysts through some of the ICHprocedures." (Metrohm Information, 4th July2005) "While most useful for pharmaceutical laboratories, it may alsobe useful in certain university and government laboratories."(E-STREAMS, February 2005) "...a treasure of helpful hints and techniques that can aideven experienced analysts through some of the ICH procedures."(Inside Laboratory Management, July/August 2004) "Given the need for generating reliable analytical data, thisbook provides practical guidance for validating common andnot-so-common analytical methods and for verifying the performanceof instruments..." (Journal of the American ChemicalSociety, June 9, 2004) "...a very useful reference text...warmlyrecommended" (Organic Process Research & DevelopmentJournal)
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