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Practical approaches to method validation and essential instrument qualification

"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...

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Bibliographic Details
Group Author: Chan, Chung Chow; Lam, Herman; Zhang, Xue-Ming
Published:
Literature type: Electronic eBook
Language: English
Subjects:
Drugs > Analysis > Methodology > Evaluation
Laboratories > Equipment and supplies > Evaluation
Laboratories > Instruments > Evaluation
MEDICAL > Drug Guides
MEDICAL > Pharmacology
MEDICAL > Pharmacy
MEDICAL > Nursing > Pharmacology
Analytische Chemie
Qualitätssicherung
Electronic books
Chemistry, Pharmaceutical > instrumentation
Chemistry, Pharmaceutical > methods
Clinical Laboratory Techniques > standards
Technology, Pharmaceutical > methods
Online Access: http://onlinelibrary.wiley.com/book/10.1002/9780470630716
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 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.
Item Description: Complement to: Method validation and instrument performance verification / edited by Chung Chow Chan ... [et al.]. c2004.
Carrier Form: 1 online resource (xiv, 399 p.) : ill.
Bibliography: Includes bibliographical references and index.
ISBN: 9780470630716 (electronic bk.)
047063071X (electronic bk.)
9780470630709 (electronic bk.)
0470630701 (electronic bk.)
Index Number: RS189
CLC: R917
Contents: (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 Chro

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