LEADER 05336nam 2200673 450 001 9910830145003321 005 20170821202236.0 010 $a1-5231-4402-5 010 $a3-527-67218-4 010 $a3-527-67220-6 010 $a3-527-67219-2 035 $a(CKB)2670000000569504 035 $a(EBL)1800892 035 $a(SSID)ssj0001374852 035 $a(PQKBManifestationID)11887287 035 $a(PQKBTitleCode)TC0001374852 035 $a(PQKBWorkID)11326024 035 $a(PQKB)11507329 035 $a(MiAaPQ)EBC1800892 035 $a(PPN)182430103 035 $a(EXLCZ)992670000000569504 100 $a20141016h20152015 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aMethod validation in pharmaceutical analysis $ea guide to best practice. /$fedited by Joachim Ermer and Phil Nethercote 205 $a2nd ed. 210 1$aWeinheim, Germany :$cWiley-VCH Verlag,$d2015. 210 4$dİ2015 215 $a1 online resource (437 p.) 300 $aDescription based upon print version of record. 311 $a3-527-33563-3 311 $a1-322-16683-8 320 $aIncludes bibliographical references and index. 327 $aMethod Validation in Pharmaceutical Analysis; Contents; Foreword; List of Contributors; Chapter 1 Analytical Validation within the Pharmaceutical Lifecycle; 1.1 Development of Process and Analytical Validation Concepts; 1.2 Alignment between Process and Analytics: Three-Stage Approach; 1.3 Predefined Objectives: Analytical Target Profile; 1.4 Analytical Life Cycle; References; Chapter 2 Analytical Instrument Qualification; 2.1 Analytical Instrument and System Qualification; 2.1.1 Data Quality and Integrity in a GMP Environment; 2.1.1.1 Criteria for Quality Data 327 $a2.1.1.2 Regulatory Rationale for Qualified Analytical Instruments2.1.2 USP General Chapter ; 2.1.2.1 Data Quality Triangle; 2.1.2.2 Analytical Instrument Qualification Life Cycle: the Four Qs Model; 2.1.2.3 Risk-Based Classification of Apparatus, Instruments, and Systems; 2.1.2.4 Roles and Responsibilities for AIQ; 2.1.2.5 Software Validation for Group B and C Systems; 2.1.3 Enhancement of and Harmonization of a Risk-Based Approach to Instruments and Systems with GAMP Laboratory GPG Second Edition; 2.1.3.1 Increased Granularity of USP Groups 327 $a2.1.3.2 Clarification of AIQ Terminology2.1.3.3 A Continuum of Analytical Apparatus, Instruments, and Systems; 2.1.3.4 Mapping USP Instrument Groups to GAMP Software Categories; 2.1.3.5 Enhanced Data Quality Triangle; 2.1.4 Risk-Based Approaches to Analytical Instrument and System Qualification; 2.1.4.1 Expanded Instrument and System Categories; 2.2 Efficient and Economic HPLC Performance Qualification; 2.2.1 Introduction; 2.2.1.1 The Importance of Analytical Instrument Qualification; 2.2.1.2 Terms and Definitions; 2.2.1.3 Continuous Performance Qualification: More by Less 327 $a2.2.2 Development of the Revised OQ/PQ Parameters List2.2.3 Transfer of Modular Parameters into the Holistic Approach; 2.2.3.1 Autosampler; 2.2.3.2 Solvent Delivery System; 2.2.3.3 Detector; 2.2.4 OQ/PQ Data in Comparison with SST Data; 2.2.5 Control Charts; 2.2.6 General Procedure for Continuous PQ; 2.2.7 Concluding Remarks; Acknowledgment; Abbreviations; References; Chapter 3 Establishment of Measurement Requirements - Analytical Target Profile and Decision Rules; 3.1 Introduction; 3.2 Defining the Fitness for Intended Use; 3.3 Decision Rules 327 $a3.4 Overview of Process to Develop Requirements for Procedure Performance3.5 Decision Rules and Compliance; 3.6 Calculating Target Measurement Uncertainty; 3.6.1 Coverage Factor, k, and Data Distributions; 3.7 Types of Decision Rules; 3.7.1 Decision Rules That Use Guard Bands; 3.8 Target Measurement Uncertainty in the Analytical Target Profile; 3.8.1 Cost of Analysis; 3.9 Bias and Uncertainty in a Procedure; 3.10 ATP and Key Performance Indicators; 3.11 Measurement Uncertainty; 3.11.1 What Uncertainty Is; 3.11.2 Reporting Measurement Uncertainty; 3.11.3 How Uncertainty is Estimated 327 $a3.11.4 Uncertainty Contains All Sources of Random Variability 330 $aThis second edition of a global best-seller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) concept in pharmaceutical manufacturing. As in the first edition, the analytical requirements during the entire product lifecycle are covered, but now a new section is included on continued performance monitoring and the transfer of analytical procedures. Two case studies from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regul 606 $aDrugs$xAnalysis 606 $aMethodology$xValidity 606 $aPharmacology 615 0$aDrugs$xAnalysis. 615 0$aMethodology$xValidity. 615 0$aPharmacology. 676 $a615.1901 702 $aErmer$b Joachim 702 $aNethercote$b Phil W. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910830145003321 996 $aMethod validation in pharmaceutical analysis$93984796 997 $aUNINA