Practical Approaches to Method Validation and

Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirementsComplementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification.Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systemsPart 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance-coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers-and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labsAt the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP).Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.

Chung Chow Chan, PhD, is a Consultant for CCC Consulting, and the former president of the Calibration Validation Group, a nonprofit organization dedicated to the art and science of instrument calibration and method validation. Herman Lam, PhD, is the Principal of Wild Crane Horizon and President of the Calibration Validation Group. Dr. Lam has developed and presented an instrument qualification and performance verification course for Agilent Technologies and other organizations in North America and Asia. Xue Ming Zhang, PhD is a Manager at Apotex, responsible for overseeing the development of stable liquid formulations. He also works on method development and validation for both instrument and chemical analysis.

Contributors	p. xi
Preface	p. xiii
Overview of Risk-Based Approach to Phase Appropriate Validation and Instrument Qualification	p. 1
Risk-Based Approach to Pharmaceutical Development	p. 1
Regulatory Requirements for Performance Verification of Instruments	p. 3
General Approach to Instrument Performance Qualification	p. 4
References	p. 10
Phase Appropriate Method Validation	p. 11
Introduction	p. 11
Parameters for Qualification and Validation	p. 14
Qualification and Validation Practices	p. 15
Common Problems and Solutions	p. 25
References	p. 25
Analytical Method Verification, Method Revalidation, and Method Transfer	p. 27
Introduction	p. 27
Cycle of Analytical Methods	p. 28
Method Verification Practices	p. 28
Method Revalidation	p. 36
Method Transfer	p. 40
Common Problems and Solutions	p. 42
References	p. 43
Validation of Process Analytical Technology Applications	p. 45
Introduction	p. 45
Parameters for Qualification and Validation	p. 48
Qualification, Validation and Verification Practices	p. 56
Common Problems and Solutions	p. 69
References	p. 73
Validation of Near-Infrared Systems for Raw Material Identification	p. 75
Introduction	p. 75
Validation of an NIR System	p. 77
Validation Plan	p. 78
References	p. 90
Cleaning Validation	p. 93
Introduction	p. 93
Scope of the Chapter	p. 94
Strategies and Validation Parameters	p. 94
Analytical Methods in Cleaning Validation	p. 100
Sampling Techniques	p. 102
Acceptance Criteria of Limits	p. 104
Campaign Cleaning Validation	p. 107
Common Problems and Solutions	p. 108
References	p. 110
Risk-Based Validation of Laboratory Information Management Systems	p. 111
Introduction	p. 111
LIMS and the LIMS Environment	p. 114
Understanding and Simplifying Laboratory Processes	p. 117
GAMP Software Categories and System Life Cycle for a LIMS	p. 121
Validation Roles and Responsibilities for a LIMS Project	p. 124
System Life-Cycle Detail and Documented Evidence	p. 126
Maintaining the Validated Status	p. 147
Summary	p. 151
References	p. 152
Performance Qualification and Verification of Balance	p. 155
Introduction	p. 155
Performance Qualification	p. 159
Common Problems and Solutions	p. 161
References	p. 169
Appendix	p. 170
Performance Verification of NIR Spectrophotometers	p. 177
Introduction	p. 177
Performance Attributes	p. 179
Practical Tips in NTR Performance Verification	p. 192
References	p. 195
Appendix 1	p. 197
Appendix 2	p. 199
Operational Qualification in Practice for Gas Chromatography Instruments	p. 201
Introduction	p. 201
Parameters for Qualification	p. 202
Operational Qualification	p. 208
Preventive Maintenance	p. 219
Common Problems and Solutions	p. 220
References	p. 229
Performance Verification on Refractive Index, Fluorescence, and Evaporative Light-Scattering Detection	p. 231
Introduction	p. 231
Qualification of Differential Refractive Index Detectors	p. 238
Qualification of Fluorescence Detectors	p. 242
Qualification of Evaporative Light-Scattering Detectors	p. 250
Reference	p. 253
Instrument Qualification and Performance Verification for Particle Size Instruments	p. 255
Introduction	p. 255
Setting the Scene	p. 257
Particle Counting Techniques	p. 258
Particle Size Analysis and Distribution	p. 259
Instrument Qualification for Particle Size	p. 260
Qualification of Instruments Used in Particle Sizing	p. 272
Method Development	p. 279
Verification: Particle Size Distribution Checklist	p. 291
Common Problems and Solutions	p. 292
Conclusions	p. 295
References	p. 295
Appendix	p. 297
Method Validation, Qualification, and Performance Verification for Total Organic Carbon Analyzers	p. 299
Introduction	p. 299
TOC Methodologies	p. 302
Parameters for Method Validation, Qualification, and Verification	p. 307
Qualification, Validation, and Verification Practices	p. 310
Common Problems and Solutions	p. 321
References	p. 323
Instrument Performance Verification: Micropipettes	p. 327
Introduction	p. 327
Scope of the Chapter	p. 328
Verification Practices: Volume Settings, Number of Replicates, and Tips	p. 338
Parameters: Accuracy, Precision, and Uncertainty	p. 342
Summary	p. 345
References	p. 346
Instrument Qualification and Performance Verification for Automated Liquid-Handling Systems	p. 347
Introduction	p. 347
Commonalities Between Volume Verification Methods for Performance Evaluation	p. 354
Volume Verification Methods	p. 356
Importance of Standardization	p. 371
Summary	p. 372
References	p. 373
Performance Qualification and Verification in Powder X-Ray Diffraction	p. 377
Introduction	p. 377
Basics of X-Ray Diffraction	p. 378
Performance Qualification	p. 381
Performance Verification: Calibration Practice	p. 387
References	p. 389
Index	p. 391
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Practical Approaches to Method Validation and Essential Instrument Qualification

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