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" Validation and qualification in analytical laboratories / "
Ludwig Huber.
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BL
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| Record Number
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1003166
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| Doc. No
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b757536
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| Main Entry
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Huber, Ludwig,1948-
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| Title & Author
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Validation and qualification in analytical laboratories /\ Ludwig Huber.
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| Edition Statement
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2nd ed.
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| Publication Statement
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New York :: Informa Healthcare,, ©2007.
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| Page. NO
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v, 303 pages :: illustrations ;; 24 cm
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| ISBN
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084938267X
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: 9780849382673
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| Bibliographies/Indexes
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Includes bibliographical references (pages 281-297) and index.
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| Contents
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Introduction -- Regulations, standards, and guidelines -- Terminology and validation overview -- Risk-based validation and qualification -- Master and project planning for equipment and computer systems -- Design qualification -- Installation qualification -- Operational qualification -- Performance qualification and maintenance -- Special considerations for software and computer systems -- Validation of analytical methods -- Data review and validation and evaluation of uncertainty -- Handling out-of-specification situations -- (Certified) reference standards -- People -- Proficiency testing for external laboratory qualification -- Audits.
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| Abstract
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"This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. This title serves as a complete source to the subject with comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory, and explains how to develop and implement a validation strategy for routine, nonroutine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections."--BOOK JACKET.
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| Subject
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Chemical laboratories-- Standards.
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Chemistry, Analytic-- Quality control.
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Chemical laboratories-- Standards.
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Chemistry, Analytic-- Quality control.
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Chemistry, Pharmaceutical-- standards.
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Chemistry Techniques, Analytical-- standards.
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Drug Industry-- standards.
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Laboratories-- standards.
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Quality Control.
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| Dewey Classification
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543.068/5
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| LC Classification
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QD75.4.Q34H83 2007
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| NLM classification
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2007 I-955
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QV 744H877v 2007
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