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035    (MiAaPQ)EBC675009 
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050  4 RS189 -- .P66 2010eb 
082 0  615/.1901 
100 1  Chan, Chung Chow 
245 10 Practical Approaches to Method Validation and Essential 
       Instrument Qualification 
250    1st ed 
264  1 Hoboken :|bWiley,|c2010 
264  4 |c©2010 
300    1 online resource (415 pages) 
336    text|btxt|2rdacontent 
337    computer|bc|2rdamedia 
338    online resource|bcr|2rdacarrier 
505 0  Intro -- PRACTICAL APPROACHES TO METHOD VALIDATION AND 
       ESSENTIAL INSTRUMENT QUALIFICATION -- CONTENTS -- 
       Contributors -- Preface -- 1 Overview of Risk-Based 
       Approach to Phase Appropriate Validation and Instrument 
       Qualification -- 1 Risk-Based Approach to Pharmaceutical 
       Development -- 2 Regulatory Requirements for Performance 
       Verification of Instruments -- 3 General Approach to 
       Instrument Performance Qualification -- References -- 2 
       Phase Appropriate Method Validation -- 1 Introduction -- 2
       Parameters for Qualification and Validation -- 3 
       Qualification and Validation Practices -- 4 Common 
       Problems and Solutions -- References -- 3 Analytical 
       Method Verification, Method Revalidation, and Method 
       Transfer -- 1 Introduction -- 2 Cycle of Analytical 
       Methods -- 3 Method Verification Practices -- 4 Method 
       Revalidation -- 5 Method Transfer -- 6 Common Problems and
       Solutions -- References -- 4 Validation of Process 
       Analytical Technology Applications -- 1 Introduction -- 2 
       Parameters for Qualification and Validation -- 3 
       Qualification, Validation, and Verification Practices -- 4
       Common Problems and Solutions -- References -- 5 
       Validation of Near-Infrared Systems for Raw Material 
       Identification -- 1 Introduction -- 2 Validation of an NIR
       System -- 3 Validation Plan -- References -- 6 Cleaning 
       Validation -- 1 Introduction -- 2 Scope of the Chapter -- 
       3 Strategies and Validation Parameters -- 4 Analytical 
       Methods in Cleaning Validation -- 5 Sampling Techniques --
       6 Acceptance Criteria of Limits -- 7 Campaign Cleaning 
       Validation -- 8 Common Problems and Solutions -- 
       References -- 7 Risk-Based Validation of Laboratory 
       Information Management Systems -- 1 Introduction -- 2 LIMS
       and the LIMS Environment -- 3 Understanding and 
       Simplifying Laboratory Processes -- 4 GAMP Software 
       Categories and System Life Cycle for a LIMS 
505 8  5 Validation Roles and Responsibilities for a LIMS Project
       -- 6 System Life-Cycle Detail and Documented Evidence -- 7
       Maintaining the Validated Status -- 8 Summary -- 
       References -- 8 Performance Qualification and Verification
       of Balance -- 1 Introduction -- 2 Performance 
       Qualification -- 3 Common Problems and Solutions -- 
       References -- Appendix -- 9 Performance Verification of 
       NIR Spectrophotometers -- 1 Introduction -- 2 Performance 
       Attributes -- 3 Practical Tips in NIR Performance 
       Verification -- References -- Appendix 1 -- Appendix 2 -- 
       10 Operational Qualification in Practice for Gas 
       Chromatography Instruments -- 1 Introduction -- 2 
       Parameters for Qualification -- 3 Operational 
       Qualification -- 4 Preventive Maintenance -- 5 Common 
       Problems and Solutions -- References -- 11 Performance 
       Verification on Refractive Index, Fluorescence, and 
       Evaporative Light-Scattering Detection -- 1 Introduction -
       - 2 Qualification of Differential Refractive Index 
       Detectors -- 3 Qualification of Fluorescence Detectors -- 
       4 Qualification of Evaporative Light-Scattering Detectors 
       -- Reference -- 12 Instrument Qualification and 
       Performance Verification for Particle Size Instruments -- 
       1 Introduction -- 2 Setting the Scene -- 3 Particle 
       Counting Techniques -- 4 Particle Size Analysis and 
       Distribution -- 5 Instrument Qualification for Particle 
       Size -- 6 Qualification of Instruments Used in Particle 
       Sizing -- 7 Method Development -- 8 Verification: Particle
       Size Distribution Checklist -- 9 Common Problems and 
       Solutions -- 10 Conclusions -- References -- Appendix -- 
       13 Method Validation, Qualification, and Performance 
       Verification for Total Organic Carbon Analyzers -- 1 
       Introduction -- 2 TOC Methodologies -- 3 Parameters for 
       Method Validation, Qualification, and Verification -- 4 
       Qualification, Validation, and Verification Practices -- 5
       Common Problems and Solutions 
505 8  References -- 14 Instrument Performance Verification: 
       Micropipettes -- 1 Introduction -- 2 Scope of the Chapter 
       -- 3 Verification Practices: Volume Settings, Number of 
       Replicates, and Tips -- 4 Parameters: Accuracy, Precision,
       and Uncertainty -- 5 Summary -- References -- 15 
       Instrument Qualification and Performance Verification for 
       Automated Liquid-Handling Systems -- 1 Introduction -- 2 
       Commonalities Between Volume Verification Methods for 
       Performance Evaluation -- 3 Volume Verification Methods --
       4 Importance of Standardization -- 5 Summary -- References
       -- 16 Performance Qualification and Verification in Powder
       X-Ray Diffraction -- 1 Introduction -- 2 Basics of X-Ray 
       Diffraction -- 3 Performance Qualification -- 4 
       Performance Verification: Calibration Practice -- 
       References -- Index 
520    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 
520 8  should turn to this book to ensure that analytical methods
       and instruments are accurate and meet GMP standards and 
       requirements 
588    Description based on publisher supplied metadata and other
       sources 
590    Electronic reproduction. Ann Arbor, Michigan : ProQuest 
       Ebook Central, 2020. Available via World Wide Web. Access 
       may be limited to ProQuest Ebook Central affiliated 
       libraries 
650  0 Drugs -- Analysis -- Methodology -- 
       Evaluation.;Laboratories -- Equipment and supplies -- 
       Evaluation.;Laboratories -- Instruments -- 
       Evaluation.;Electronic books 
655  4 Electronic books 
700 1  Lam, Herman 
700 1  Zhang, Xue-Ming 
776 08 |iPrint version:|aChan, Chung Chow|tPractical Approaches 
       to Method Validation and Essential Instrument 
       Qualification|dHoboken : Wiley,c2010|z9780470121948 
856 40 |uhttps://ebookcentral.proquest.com/lib/sinciatw/
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