Practical Approaches to Method Validation and Essential Instrument Qualification / Edition 1

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Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements

Complementing 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 systems
  • Part 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 labs

At 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.

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Product Details

  • ISBN-13: 9780470121948
  • Publisher: Wiley
  • Publication date: 10/4/2010
  • Edition number: 1
  • Pages: 416
  • Sales rank: 1,288,384
  • Product dimensions: 6.30 (w) x 9.30 (h) x 1.20 (d)

Meet the Author

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.

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Table of Contents



1 Overview of Risk-Based Approach to Phase Appropriate Validation and Instrument Qualification Wolfgang Winter Winter, Wolfgang 1

1 Risk-Based Approach to Pharmaceutical Development 1

2 Regulatory Requirements for Performance Verification of Instruments 3

3 General Approach to Instrument Performance Qualification 4

References 10

2 Phase Appropriate Method Validation Pramod Saraswat Saraswat, Pramod 11

1 Introduction 11

2 Parameters for Qualification and Validation 14

3 Qualification and Validation Practices 15

4 Common Problems and Solutions 25

References 25

3 Analytical Method Verification, Method Revalidation, and Method Transfer Pramod Saraswat Saraswat, Pramod 27

1 Introduction 27

2 Cycle of Analytical Methods 28

3 Method Verification Practices 28

4 Method Revalidation 36

5 Method Transfer 40

6 Common Problems and Solutions 42

References 43

4 Validation of Process Analytical Technology Applications Alison C. E. Harrington Harrington, Alison C. E. 45

1 Introduction 45

2 Parameters for Qualification and Validation 48

3 Qualification, Validation, and Verification Practices 56

4 Common Problems and Solutions 69

References 73

5 Validation of Near-Infrared Systems for Raw Material Identification Lenny Dass Dass, Lenny 75

1 Introduction 75

2 Validation of an NIR System 77

3 Validation Plan 78

References 90

6 Cleaning Validation Anthony Qu Qu, Anthony 93

1 Introduction 93

2 Scope of the Chapter 94

3 Strategies and Validation Parameters 94

4 Analytical Methods in Cleaning Validation 100

5 Sampling Techniques 102

6 Acceptance Criteria of Limits 104

7 Campaign Cleaning Validation 107

8 Common Problems and Solutions 108

References 110

7 Risk-Based Validation of Laboratory Information Management Systems R. D. McDowall McDowall, R. D. 111

1 Introduction 111

2 LIMS and the LIMS Environment 114

3 Understanding and Simplifying Laboratory Processes 117

4 GAMP Software Categories and System Life Cycle for a LIMS 121

5 Validation Roles and Responsibilities for a LIMS Project 124

6 System Life-Cycle Detail and Documented Evidence 126

7 Maintaining the Validated Status 147

8 Summary 151

References 152

8 Performance Qualification and Verification of Balance Ian Ciesniewski Ciesniewski, Ian 155

1 Introduction 155

2 Performance Qualification 159

3 Common Problems and Solutions 161

References 169

Appendix 170

9 Performance Verification of NIR Spectrophotometers Shauna Rotman Rotman, Shauna 177

1 Introduction 177

2 Performance Attributes 179

3 Practical Tips in NIR Performance Verification 192

References 195

Appendix 1 197

Appendix 2 199

10 Operational Qualification in Practice for Gas Chromatography Instruments Herman Lam Lam, Herman 201

1 Introduction 201

2 Parameters for Qualification 202

3 Operational Qualification 208

4 Preventive Maintenance 219

5 Common Problems and Solutions 220

References 229

11 Performance Verification on Refractive Index, Fluorescence, and Evaporative Light-Scattering Detection Richard W. Andrews Andrews, Richard W. 231

1 Introduction 231

2 Qualification of Differential Refractive Index Detectors 238

3 Qualification of Fluorescence Detectors 242

4 Qualification of Evaporative Light-Scattering Detectors 250

Reference 253

12 Instrument Qualification and Performance Verification for Particle Size Instruments Alan F. Rawle Rawle, Alan F. 255

1 Introduction 255

2 Setting the Scene 257

3 Particle Counting Techniques 258

4 Particle Size Analysis and Distribution 259

5 Instrument Qualification for Particle Size 260

6 Qualification of Instruments Used in Particle Sizing 272

7 Method Development 279

8 Verification: Particle Size Distribution Checklist 291

9 Common Problems and Solutions 292

10 Conclusions 295

References 295

Appendix 297

13 Method Validation, Qualification, and Performance Verification for Total Organic Carbon Analyzers Jose E. Martinez-Rosa Martinez-Rosa, Jose E. 299

1 Introduction 299

2 TOC Methodologies 302

3 Parameters for Method Validation, Qualification, and Verification 307

4 Qualification, Validation, and Verification Practices 310

5 Common Problems and Solutions 321

References 323

14 Instrument Performance Verification: Micropipettes Richard Curtis Curtis, Richard 327

1 Introduction 327

2 Scope of the Chapter 328

3 Verification Practices: Volume Settings, Number of Replicates, and Tips 338

4 Parameters: Accuracy, Precision, and Uncertainty 342

5 Summary 345

References 346

15 Instrument Qualification and Performance Verification for Automated Liquid-Handling Systems Keith J. Albert Albert, Keith J. 347

1 Introduction 347

2 Commonalities Between Volume Verification Methods for Performance Evaluation 354

3 Volume Verification Methods 356

4 Importance of Standardization 371

5 Summary 372

References 373

16 Performance Qualification and Verification in Powder X-Ray Diffraction Aniceta Skowron Skowron, Aniceta 377

1 Introduction 377

2 Basics of X-Ray Diffraction 378

3 Performance Qualification 381

4 Performance Verification: Calibration Practice 387

References 389

Index 391

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