Analytical Method Validation and Instrument Performance Verification
1st Edition
Published on 25. February 2004
Book
Hardback
320 pages
978-0-471-25953-4 (ISBN)
Description
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.
Reviews / Votes
"It is a treasure of helpful hints and techniques which can aid even experienced analysts through some of the ICH procedures." (Metrohm Information, 4th July 2005) "While most useful for pharmaceutical laboratories, it may also be useful in certain university and government laboratories." (E-STREAMS, February 2005)"...a treasure of helpful hints and techniques that can aid even experienced analysts through some of the ICH procedures." (Inside Laboratory Management, July/August 2004)
"Given the need for generating reliable analytical data, this book provides practical guidance for validating common and not-so-common analytical methods and for verifying the performance of instruments..." (Journal of the American Chemical Society, June 9, 2004)
"...a very useful reference text...warmly recommended" (Organic Process Research & Development Journal)
More details
Product info
GB
Edition
1., Auflage
Language
English
Place of publication
United States
Publishing group
John Wiley & Sons Inc
Target group
Professional and scholarly
Product notice
sewn/stitched
Cloth over boards
Dimensions
Height: 240 mm
Width: 161 mm
Thickness: 22 mm
Weight
648 gr
ISBN-13
978-0-471-25953-4 (9780471259534)
Schweitzer Classification
Other editions
Additional editions
Chung Chow Chan | Y. C. Lee | Herman Lam
Analytical Method Validation and Instrument Performance Verification
E-Book
04/2004
Wiley
€141.99
Available for download
Persons
CHUNG CHOW CHAN is a Research Scientist at Eli Lilly Canada, Inc.
Y. C. LEE is the associate director of Patheon YM, Inc., in Canada.
HERMAN LAM is Manager of Automation and Lab Systems at Glaxo Smith Kline Canada.
XUE-MING ZHANG is a Supervisor at Novex Pharma. Chung Chow, Herman, and Y. C. are the founders of the Calibration and Validation Group (CVG). CVG is a scientific organization based in Canada that focuses on the advancement of the sciences in method validation and instrument qualification.
Content
Contributors.
Preface.
1. Overview of Pharmaceutical Product Development and Its Associated Quality System (C. Chan & E. Jensen).
2. Potency Method Validation (C. Chan).
3. Method Validation for HPLC Analysis of Related Substances in Pharmaceutical Drug Products (Y. Lee).
4. Dissolution Method Validation (C. Chan, et al.).
5. Development and Validation of Automated Methods (C. Incledon & H. Lam).
6. Analysis of Pharmaceutical Inactive Ingredients (X. Zhang).
7. Validation Study of JP Heavy Metal Limit Test (Y. Nishiyama).
8. Bioanalytical Method Validation (F. Garofolo).
9. Procurement, Qualification, and Calibration of Laboratory Instruments: An Overview (H. Lam).
10. Performance Verification of UV-Vis Spectrophotometers (H. Lam).
11. Performance Verification of HPLC (H. Lam).
12. Operational Qualification of a Capillary Electrophoresis Instrument (N. Baryla).
13. LC-MS Instrument Calibration (F. Garofolo).
14. Karl Fisher Apparatus and Its Performance Verification (R. Jairam, et al.).
15. The pH Meter and Its Performance Verification (Y. Tse, et al.).
16. Qualification of Environmental Chambers (G. Wong & H. Lam).
17. Equipment Qualification and Computer System Validation (L. Huber).
18. Validation of Excel Spreadsheet (H. Brunner).
Index.