Description
Book SynopsisProvides a discussion of the regulatory requirements of FDA, ICH, Europe, and Japan as they pertain to calibration of instruments and validation of methods. This book offers practical tips on how to validate techniques. It explains why different approaches are necessary in biopharmaceutical and bioanalytical methods validation.
Trade Review“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)
Table of ContentsContributors.
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.
