Analytical Method Validation and Instrument Performance Verification

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. 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.

“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)

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.

Teaches proper procedures for using tools and analytical methods in a regulated lab setting
All regulated laboratories, including pharmaceutical, clinical testing, and food and cosmetics testing laboratories, must properly execute the calibration of instruments and validation of analytical methods. Following correct procedures ensures the generation of reliable data, which leads to the manufacture of safe and effective products.

Analytical Method Validation and Instrument Performance Verification provides a uniquely practical approach to method validation and instrument performance verification. Each chapter starts with general requirements, then moves to the strategies and steps taken to fulfill these conditions, and finishes with a discussion of practical problems and their solutions. Coverage includes:

• Method validation of potency, related substances, and dissolution testing
• Validation for pharmaceutical excipients, heavy metals, and bioanalysis
• Performance verification for common analytical instruments including HPLC, UV-Vis spectrophotometers, and pH meters
• The LCMS system calibration
• Proper environmental chamber qualification
• Entire qualification process for computer equipment, hardware, and software
• Validation of Excel spreadsheets
• Regulatory requirements of the FDA, ICH, Europe, and Japan

Full of practical tips on validation techniques and detailed discussions of instrument performance verification, this comprehensive guide represents a one-stop reference for remaining current in today's regulatory environment.

Analytical Method Validation and Instrument Performance Verification provides an invaluable working reference for laboratory managers, calibration scientists, and research and development scientists.