Edited by
CHUNG CHOW CHAN
Eli Lilly Canada, Inc.
HERMAN LAM
GlaxoSmithKline Canada, Inc.
Y. C. LEE
Patheon YM, Inc.
XUE-MING ZHANG
Novex Pharma
Contributors vii
Preface ix
1 Overview of Pharmaceutical Product Development and Its
Associated Quality System 1
Chung Chow Chan and Eric Jensen
2 Potency Method Validation 11
Chung Chow Chan
3 Method Validation for HPLC Analysis of Related Substances
in Pharmaceutical Drug Products 27
Y. C. Lee
4 Dissolution Method Validation 51
Chung Chow Chan, Neil Pearson, Anna Rebelo-Cameirao, and Y. C. Lee
5 Development and Validation of Automated Methods 67
Chantal Incledon and Herman Lam
6 Analysis of Pharmaceutical Inactive Ingredients 85
Xue-Ming Zhang
7 Validation Study of JP Heavy Metal Limit Test 95
Yoshiki Nishiyama
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vi CONTENTS
8 Bioanalytical Method Validation 105
Fabio Garofolo
9 Procurement, Qualification, and Calibration of Laboratory
Instruments: An Overview 139
Herman Lam
10 Performance Verification of UV–Vis Spectrophotometers 153
Herman Lam
11 Performance Verification of HPLC 173
Herman Lam
12 Operational Qualification of a Capillary Electrophoresis
Instrument 187
Nicole E. Baryla
13 LC-MS Instrument Calibration 197
Fabio Garofolo
14 Karl Fisher Apparatus and Its Performance Verification 221
Rick Jairam, Robert Metcalfe, and Yu-Hong Tse
15 The pH Meter and Its Performance Verification 229
Yu-Hong Tse, Rick Jairam, and Robert Metcalfe
16 Qualification of Environmental Chambers 243
Gilman Wong and Herman Lam
17 Equipment Qualification and Computer System Validation 255
Ludwig Huber
18 Validation of Excel Spreadsheet 277
Heiko Brunner
Index 299
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