Analytical Method Validation & Instrument Calibration / Edition 1

Analytical Method Validation & Instrument Calibration / Edition 1

by Chung Chow Chan
     
 

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

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Overview

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 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 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.

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Product Details

ISBN-13:
9780471259534
Publisher:
Wiley
Publication date:
02/06/2004
Edition description:
New Edition
Pages:
320
Product dimensions:
6.44(w) x 9.29(h) x 0.93(d)

Table of Contents

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.

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