Analytical method validation and instrument performance verification

Chung Chow Chan

303 pages, parution le 10/03/2004

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Résumé

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.

Sommaire

Overview of Pharmaceutical Product Development and Its Associated Quality System (C. Chan & E. Jensen).
Potency Method Validation (C. Chan).
Method Validation for HPLC Analysis of Related Substances in Pharmaceutical Drug Products (Y. Lee).
Dissolution Method Validation (C. Chan, et al.).
Development and Validation of Automated Methods (C. Incledon & H. Lam).
Analysis of Pharmaceutical Inactive Ingredients (X. Zhang).
Validation Study of JP Heavy Metal Limit Test (Y. Nishiyama).
Bioanalytical Method Validation (F. Garofolo).
Procurement, Qualification, and Calibration of Laboratory Instruments: An Overview (H. Lam).
Performance Verification of UV-Vis Spectrophotometers (H. Lam).
Performance Verification of HPLC (H. Lam).
Operational Qualification of a Capillary Electrophoresis Instrument (N. Baryla).
LC-MS Instrument Calibration (F. Garofolo).
Karl Fisher Apparatus and Its Performance Verification (R. Jairam, et al.).
The pH Meter and Its Performance Verification (Y. Tse, et al.).
Qualification of Environmental Chambers (G. Wong & H. Lam).
Equipment Qualification and Computer System Validation (L. Huber).
Validation of Excel Spreadsheet (H. Brunner).
Index

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Caractéristiques techniques

	PAPIER
Éditeur(s)	Wiley
Auteur(s)	Chung Chow Chan
Parution	10/03/2004
Nb. de pages	303
Format	16 x 24,5
Couverture	Relié
Poids	574g
Intérieur	Noir et Blanc
EAN13	9780471259534
ISBN13	978-0-471-25953-4