Analytical Method Validation and Instrument Performance Verification

Teaches proper procedures for using tools and analyticalmethods in a regulated lab setting
All regulated laboratories, including pharmaceutical, clinical testing, and food and cosmetics testing laboratories, must properly execute the calibrationof instruments and validation of analytical methods. Following correctprocedures ensures the generation of reliable data, which leads to themanufacture of safe and effective products.
Analytical Method Validation and Instrument PerformanceVerification provides a uniquely practical approach to method validation andinstrument performance verification. Each chapter starts with generalrequirements, 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 testingValidation for pharmaceutical excipients, heavy metals, and bioanalysisPerformance verification for common analytical instruments including HPLC, UV–Vis spectrophotometers, and pH metersThe LCMS system calibrationProper environmental chamber qualificationEntire qualification process for computer equipment, hardware, and softwareValidation of Excel spreadsheetsRegulatory requirements of the FDA, ICH, Europe, and Japan
Full of practical tips on validation techniques and detaileddiscussions of instrument performance verification, this comprehensive guiderepresents 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 researchand development scientists.

Spis treści:
Contributors.
Preface.
1. Overview of Pharmaceutical Product Development and Its Associated Quality System (C. Chan & ;amp; 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.

Nota biograficzna:
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.

Okładka tylna:
Teaches proper procedures for using tools and analyticalmethods in a regulated lab setting
All regulated laboratorie s, including pharmaceutical, clinical testing, and food and cosmetics testing laboratories, must properly execute the calibrationof instruments and validation of analytical methods. Following correctprocedures ensures the generation of reliable data, which leads to themanufacture of safe and effective products.
Analytical Method Validation and Instrument PerformanceVerification provides a uniquely practical approach to method validation andinstrument performance verification. Each chapter starts with generalrequirements, 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 testingValidation for pharmaceutical excipients, heavy metals, and bioanalysisPerformance verification for common analytical instruments including HPLC, UV–Vis spectrophotometers, and pH metersThe LCMS system calibrationProper environmental chamber qualificationEntire qualification process for computer equipment, hardware, and softwareValidation of Excel spreadsheetsRegulatory requirements of the FDA, ICH, Europe, and Japan
Full of practical tips on validation techniques and detaileddiscussions of instrument performance verification, this comprehensive guiderepresents 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 researchand development scientists.