Analytical Method Validation and Instrument Performance Verification
Published on 9. April 2004
320 pages
978-0-471-46371-9 (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 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)More details
Other editions
Additional editions
Software
03/2004
Wiley
€158.58
Shipment within 10-20 days
Tze-Fun Chan | Herman Lam | Y. C. Lee
Analytical Method Validation and Instrument Performance Verification
Book
02/2004
1st Edition
Wiley
€160.50
Shipment within 10-20 days
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 atGlaxo Smith Kline Canada.
XUE-MING ZHANG is a Supervisor at Novex Pharma. ChungChow, Herman, and Y. C. are the founders of the Calibration andValidation Group (CVG). CVG is a scientific organization based inCanada that focuses on the advancement of the sciences in methodvalidation and instrument qualification.
Content
Contributors.
Preface.
1. Overview of Pharmaceutical Product Development and ItsAssociated Quality System (C. Chan & E. Jensen).
2. Potency Method Validation (C. Chan).
3. Method Validation for HPLC Analysis of Related Substances inPharmaceutical 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 LaboratoryInstruments: 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 ElectrophoresisInstrument (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, etal.).
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.
