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Practical approaches to method validation and essential instrument qualification
- Available as
- Online
- Physical
- Summary
-
"The objective of this book is provide information in same practical, hands-on manner as the first book "Analytical Method Validation and Instrument Performance Verification", on important, but mor...
"The objective of this book is provide information in same practical, hands-on manner as the first book "Analytical Method Validation and Instrument Performance Verification", on important, but more advance topics. It will focus on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testings. These tests will generate reliable data that is in compliance with current Good Manufacturing Practices (cGMP) and will follow Good Analytical Practices"--Provided by publisher.
Details
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- Creator
- edited by Chung Chow Chan, Herman Lam, Xue Ming Zhang
- Included Title
-
- Method validation and instrument performance verification
- Format
- Books
- Language
- English
- Contributors
- Publication
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- Hoboken, N.J. : Wiley, [2010]
- ©2010
- Physical Details
-
- xiv, 399 pages : illustrations ; 25 cm
- ISBNs
- 9780470121948, 9780470630709, 047063071X, 0470630701, 0470121947, 9780470630716
- OCLC
- ocn502278538, ocn681349723
- Complement to: Method validation and instrument performance verification / edited by Chung Chow Chan ... [et al.]. c2004.
- Includes bibliographical references and index.
- Machine generated contents note: 1.Overview of Risk-Based Approach to Phase Appropriate Validation and Instrument Qualification / Wolfgang Winter -- 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 / Pramod Saraswat -- 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 / Pramod Saraswat -- 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 / Alison C. E. Harrington -- 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 / Lenny Dass -- 1.Introduction -- 2.Validation of an NIR System -- 3.Validation Plan -- References -- 6.Cleaning Validation / Anthony Qu -- 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 / R. D. McDowall -- 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 -- 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 / Ian Ciesniewski -- 1.Introduction -- 2.Performance Qualification -- 3.Common Problems and Solutions -- References -- Appendix -- 9.Performance Verification of NIR Spectrophotometers / Shauna Rotman -- 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 / Herman Lam -- 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 / Richard W. Andrews -- 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 / Alan F. Rawle -- 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 / Jose E. Martinez-Rosa -- 1.Introduction -- 2.TOC Methodologies -- 3.Parameters for Method Validation, Qualification, and Verification -- 4.Qualification, Validation, and Verification Practices -- 5.Common Problems and Solutions -- References -- 14.Instrument Performance Verification: Micropipettes / Richard Curtis -- 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 / Keith J. Albert -- 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 / Aniceta Skowron -- 1.Introduction -- 2.Basics of X-Ray Diffraction -- 3.Performance Qualification -- 4.Performance Verification: Calibration Practice -- References