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Method validation in pharmaceutical analysis : a guide to best practice. / / edited by Joachim Ermer and Phil Nethercote
| Method validation in pharmaceutical analysis : a guide to best practice. / / edited by Joachim Ermer and Phil Nethercote |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | Weinheim, Germany : , : Wiley-VCH Verlag, , 2015 |
| Descrizione fisica | 1 online resource (437 p.) |
| Disciplina | 615.1901 |
| Soggetto topico |
Drugs - Analysis
Methodology - Validity Pharmacology |
| ISBN |
1-5231-4402-5
3-527-67218-4 3-527-67220-6 3-527-67219-2 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Method 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
2.1.1.2 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 2.1.3.2 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 2.2.2 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 3.4 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 3.11.4 Uncertainty Contains All Sources of Random Variability |
| Record Nr. | UNINA-9910140505703321 |
| Weinheim, Germany : , : Wiley-VCH Verlag, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Method validation in pharmaceutical analysis : a guide to best practice. / / edited by Joachim Ermer and Phil Nethercote
| Method validation in pharmaceutical analysis : a guide to best practice. / / edited by Joachim Ermer and Phil Nethercote |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | Weinheim, Germany : , : Wiley-VCH Verlag, , 2015 |
| Descrizione fisica | 1 online resource (437 p.) |
| Disciplina | 615.1901 |
| Soggetto topico |
Drugs - Analysis
Methodology - Validity Pharmacology |
| ISBN |
1-5231-4402-5
3-527-67218-4 3-527-67220-6 3-527-67219-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Method 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
2.1.1.2 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 2.1.3.2 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 2.2.2 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 3.4 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 3.11.4 Uncertainty Contains All Sources of Random Variability |
| Record Nr. | UNINA-9910830145003321 |
| Weinheim, Germany : , : Wiley-VCH Verlag, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
