Practical Approaches to Method Validation and Essential Instrument

All regulated laboratories, including pharmaceutical, clinical testing, food and cosmetic laboratories, must properly execute the calibration of instruments and validation of analytical methods. Advance Technologies in Instrumentation, Qualification, Performance, Verification and Analytical Methods Validation skillfully explains important, but advanced, techniques of method validation and instrument performance. The book covers validation of methods for significant new or evolving procedures, such as proteomic assays, rapid microbial identification, and process analytical technologies, making this text a must-read for analysts, scientists, engineers, technologists, and technical managers.

ISBN	0470121947	Pages	400
ISBN13	9780470121948 (What's this?)	Volumes	001
Publisher	John Wiley and Sons Ltd	Weight (grammes)	768
Imprint	Wiley-Blackwell (an imprint of John Wiley & Sons Ltd)	Published in	Chicester
Format	Hardback	Height (mm)	242
Publication date	10 Sep 2010	Width (mm)	166
Library of Congress	Q180.56	Spine width (mm)	25
DEWEY	543.19	Academic level	Professional / Scholarly
DEWEY edition	DC22

	Contributors
	Preface
1	Overview of Risk-Based Approach to Phase Appropriate Validation and Instrument Qualification by Wolfgang Winter	1
1	Risk-Based Approach to Pharmaceutical Development	1
2	Regulatory Requirements for Performance Verification of Instruments	3
3	General Approach to Instrument Performance Qualification	4
	References	10
2	Phase Appropriate Method Validation by Pramod Saraswat	11
1	Introduction	11
2	Parameters for Qualification and Validation	14
3	Qualification and Validation Practices	15
4	Common Problems and Solutions	25
	References	25
3	Analytical Method Verification, Method Revalidation, and Method Transfer by Pramod Saraswat	27
1	Introduction	27
2	Cycle of Analytical Methods	28
3	Method Verification Practices	28
4	Method Revalidation	36
5	Method Transfer	40
6	Common Problems and Solutions	42
	References	43
4	Validation of Process Analytical Technology Applications by Alison C. E. Harrington	45
1	Introduction	45
2	Parameters for Qualification and Validation	48
3	Qualification, Validation, and Verification Practices	56
4	Common Problems and Solutions	69
	More...

Be the first to write a customer review

Practical Approaches to Method Validation and Essential Instrument

Buying options