Practical approaches to method validation and essential instrument performance verification
.PUBLICATION, DISTRIBUTION, ETC
Place of Publication, Distribution, etc.
Hoboken, N.J.
Name of Publisher, Distributor, etc.
Wiley
Date of Publication, Distribution, etc.
c2010
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
xiv, 399 p.: ill.
GENERAL NOTES
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Complement to: Method validation and instrument performance verification/ edited by Chung Chow Chan ... ]et al.[. c2004
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Includes bibliographical references and index
NOTES PERTAINING TO TITLE AND STATEMENT OF RESPONSIBILITY
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edited by Chung C. Chan, Herman Lam, Xue-Ming Zhang
ORIGINAL VERSION NOTE
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1
CONTENTS NOTE
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)Publisher-supplied data ( Overview of Risk Based Approach to Phase Appropriate Validation and Instrument Qualification / Phase Appropriate Method Validation / Analytical Method Verification, Method Revalidation, and Method Transfer / Validation of PAT Applications / The Validation of Near Infrared Systems for Raw Material Identification / Cleaning Validation / Risk Based Validation of laboratory Information Management Systems )LIMS( / Performance Qualification and Verification of Balance / Performance Verification of NIR Spectrophotometers / Operational Qualification in Practice for Gas Chromatography Instruments / Performance Verification on RI, Fluorescence, Evaporative Light Scattering Detection / Instrument Qualification and Performance Verification for Particle Size Instruments / Method Validation, Qualification, and Performance Verification for Total Organic Carbon )TOC( Analyzers / Instrument Performance Verification ? Micro Pipettes / Instrument Qualification and Performance Verification for Automated Liquid Handling Systems / Performance Qualification and Verification in Powder X-ray Diffraction
TOPICAL NAME USED AS SUBJECT
Entry Element
Methodology - Evaluation ، Drugs - Analysis
Entry Element
Equipment and supplies - Evaluation ، Laboratories