Analytical Method Validation and Instrument Performance Verification

✍ Scribed by Chung Chow Chan, Y. C. Lee, Herman Lam, Xue-Ming Zhang

• Publisher: Wiley-Interscience
• Year: 2004
• Tongue: English
• Leaves: 316
• Edition: 1
• Category: Library

✦ Synopsis

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.

✦ Table of Contents

Team DDU......Page 1
CONTENTS......Page 8
Contributors......Page 10
Preface......Page 12
1 Overview of Pharmaceutical Product Development and Its Associated Quality System......Page 14
2 Potency Method Validation......Page 24
3 Method Validation for HPLC Analysis of Related Substances in Pharmaceutical Drug Products......Page 40
4 Dissolution Method Validation......Page 64
5 Development and Validation of Automated Methods......Page 80
6 Analysis of Pharmaceutical Inactive Ingredients......Page 98
7 Validation Study of JP Heavy Metal Limit Test......Page 108
8 Bioanalytical Method Validation......Page 118
9 Procurement, Quali.cation, and Calibration of Laboratory Instruments: An Overview......Page 152
10 Performance Veri.cation of UV-Vis Spectrophotometers......Page 166
11 Performance Veri.cation of HPLC......Page 186
12 Operational Quali.cation of a Capillary Electrophoresis Instrument......Page 200
13 LC-MS Instrument Calibration......Page 210
14 Karl Fisher Apparatus and Its Performance Veri.cation......Page 234
15 The pH Meter and Its Performance Veri.cation......Page 242
16 Quali.cation of Environmental Chambers......Page 256
17 Equipment Quali.cation and Computer System Validation......Page 268
18 Validation of Excel Spreadsheet......Page 290
Index......Page 312