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This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing.
As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout.
The undisputed gold standard in the field.
As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout.
The undisputed gold standard in the field.
This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing.
As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout.
The undisputed gold standard in the field.
As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout.
The undisputed gold standard in the field.
Inhaltsverzeichnis
Foreword
ANALYTICAL VALIDATION WITHIN THE PHARMACEUTICAL LIFECYCLE
Development of Process and Analytical Validation Concepts
Alignment between Process and Analytics: Three-Stage Approach
Predefined Objectives: Analytical Target Profile
Analytical Life Cycle
ANALYTICAL INSTRUMENT QUALIFICATION
Analytical Instrument and System Qualification
Efficient and Economic HPLC Performance Qualification
ESTABLISHMENT OF MEASUREMENT REQUIREMENTS - ANALYTICAL TARGET PROFILE AND DECISION RULES
Introduction
Defining the Fitness for Intended Use
Decision Rules
Overview of Process to Develop Requirements for Procedure Performance
Decision Rules and Compliance
Calculating Target Measurement Uncertainty
Types of Decision Rules
Target Measurement Uncertainty in the Analytical Target Profile
Bias and Uncertainty in a Procedure
ATP and Key Performance Indicators
Measurement Uncertainty
Example
Conclusion
ESTABLISHMENT OF MEASUREMENT REQUIREMENTS - PERFORMANCE-BASED SPECIFICATION
Introduction
Intended Purpose
Identification
Assay
Impurities
Limit Tests
Quantitative Tests
Summary
METHOD PERFORMANCE CHARACTERISTICS
Introduction
Precision
Accuracy and Range
Specificity
Linearity
Detection and Quantitation Limit
Glossary
METHOD DESIGN AND UNDERSTANDING
Introduction
Analytical Quality by Design and Robustness Investigations
Case Study: Robustness Investigations
System Suitability Tests
METHOD PERFORMANCE QUALIFICATION
Introduction
Case Study: Qualification of an HPLCMethod for Identity, Assay, and Degradation Products
Design and Qualification of a Delivered Dose Uniformity Procedure for a Pressurized Metered Dose Inhaler
Implementation of Compendial/Pharmacopeia Test Procedures
Transfer of Analytical Procedures
CONTINUED METHOD PERFORMANCE VERIFICATION
Introduction
Routine Monitoring
Investigating and Addressing Aberrant Data
Continual Improvement
Index
ANALYTICAL VALIDATION WITHIN THE PHARMACEUTICAL LIFECYCLE
Development of Process and Analytical Validation Concepts
Alignment between Process and Analytics: Three-Stage Approach
Predefined Objectives: Analytical Target Profile
Analytical Life Cycle
ANALYTICAL INSTRUMENT QUALIFICATION
Analytical Instrument and System Qualification
Efficient and Economic HPLC Performance Qualification
ESTABLISHMENT OF MEASUREMENT REQUIREMENTS - ANALYTICAL TARGET PROFILE AND DECISION RULES
Introduction
Defining the Fitness for Intended Use
Decision Rules
Overview of Process to Develop Requirements for Procedure Performance
Decision Rules and Compliance
Calculating Target Measurement Uncertainty
Types of Decision Rules
Target Measurement Uncertainty in the Analytical Target Profile
Bias and Uncertainty in a Procedure
ATP and Key Performance Indicators
Measurement Uncertainty
Example
Conclusion
ESTABLISHMENT OF MEASUREMENT REQUIREMENTS - PERFORMANCE-BASED SPECIFICATION
Introduction
Intended Purpose
Identification
Assay
Impurities
Limit Tests
Quantitative Tests
Summary
METHOD PERFORMANCE CHARACTERISTICS
Introduction
Precision
Accuracy and Range
Specificity
Linearity
Detection and Quantitation Limit
Glossary
METHOD DESIGN AND UNDERSTANDING
Introduction
Analytical Quality by Design and Robustness Investigations
Case Study: Robustness Investigations
System Suitability Tests
METHOD PERFORMANCE QUALIFICATION
Introduction
Case Study: Qualification of an HPLCMethod for Identity, Assay, and Degradation Products
Design and Qualification of a Delivered Dose Uniformity Procedure for a Pressurized Metered Dose Inhaler
Implementation of Compendial/Pharmacopeia Test Procedures
Transfer of Analytical Procedures
CONTINUED METHOD PERFORMANCE VERIFICATION
Introduction
Routine Monitoring
Investigating and Addressing Aberrant Data
Continual Improvement
Index
Details
| Erscheinungsjahr: | 2014 |
|---|---|
| Fachbereich: | Theoretische Chemie |
| Genre: | Chemie, Mathematik, Medizin, Naturwissenschaften, Technik |
| Rubrik: | Naturwissenschaften & Technik |
| Medium: | Buch |
| Inhalt: | ForewordANALYTICAL VALIDATION WITHIN THE PHARMACEUTICAL LIFECYCLEDevelopment of Process and Analytical Validation ConceptsAlignment between Process and Analytics: Three-Stage ApproachPredefined Objectives: Analytical Target ProfileAnalytical Life CycleAN |
| ISBN-13: | 9783527335633 |
| ISBN-10: | 3527335633 |
| Sprache: | Englisch |
| Herstellernummer: | 1133563 000 |
| Redaktion: |
Ermer, Joachim
Nethercote, Phil W. |
| Auflage: | 2. Aufl. |
| Hersteller: | Wiley-VCH |
| Verantwortliche Person für die EU: | Wiley-VCH GmbH, Postfach:10 11 61, D-69469 Weinheim, wiley.buha@zeitfracht.de |
| Abbildungen: | 140 SW-Abb., 10 Farbabb., 100 Tabellen |
| Maße: | 250 x 173 x 25 mm |
| Von/Mit: | Joachim Ermer (u. a.) |
| Erscheinungsdatum: | 14.10.2014 |
| Gewicht: | 0,95 kg |
Inhaltsverzeichnis
Foreword
ANALYTICAL VALIDATION WITHIN THE PHARMACEUTICAL LIFECYCLE
Development of Process and Analytical Validation Concepts
Alignment between Process and Analytics: Three-Stage Approach
Predefined Objectives: Analytical Target Profile
Analytical Life Cycle
ANALYTICAL INSTRUMENT QUALIFICATION
Analytical Instrument and System Qualification
Efficient and Economic HPLC Performance Qualification
ESTABLISHMENT OF MEASUREMENT REQUIREMENTS - ANALYTICAL TARGET PROFILE AND DECISION RULES
Introduction
Defining the Fitness for Intended Use
Decision Rules
Overview of Process to Develop Requirements for Procedure Performance
Decision Rules and Compliance
Calculating Target Measurement Uncertainty
Types of Decision Rules
Target Measurement Uncertainty in the Analytical Target Profile
Bias and Uncertainty in a Procedure
ATP and Key Performance Indicators
Measurement Uncertainty
Example
Conclusion
ESTABLISHMENT OF MEASUREMENT REQUIREMENTS - PERFORMANCE-BASED SPECIFICATION
Introduction
Intended Purpose
Identification
Assay
Impurities
Limit Tests
Quantitative Tests
Summary
METHOD PERFORMANCE CHARACTERISTICS
Introduction
Precision
Accuracy and Range
Specificity
Linearity
Detection and Quantitation Limit
Glossary
METHOD DESIGN AND UNDERSTANDING
Introduction
Analytical Quality by Design and Robustness Investigations
Case Study: Robustness Investigations
System Suitability Tests
METHOD PERFORMANCE QUALIFICATION
Introduction
Case Study: Qualification of an HPLCMethod for Identity, Assay, and Degradation Products
Design and Qualification of a Delivered Dose Uniformity Procedure for a Pressurized Metered Dose Inhaler
Implementation of Compendial/Pharmacopeia Test Procedures
Transfer of Analytical Procedures
CONTINUED METHOD PERFORMANCE VERIFICATION
Introduction
Routine Monitoring
Investigating and Addressing Aberrant Data
Continual Improvement
Index
ANALYTICAL VALIDATION WITHIN THE PHARMACEUTICAL LIFECYCLE
Development of Process and Analytical Validation Concepts
Alignment between Process and Analytics: Three-Stage Approach
Predefined Objectives: Analytical Target Profile
Analytical Life Cycle
ANALYTICAL INSTRUMENT QUALIFICATION
Analytical Instrument and System Qualification
Efficient and Economic HPLC Performance Qualification
ESTABLISHMENT OF MEASUREMENT REQUIREMENTS - ANALYTICAL TARGET PROFILE AND DECISION RULES
Introduction
Defining the Fitness for Intended Use
Decision Rules
Overview of Process to Develop Requirements for Procedure Performance
Decision Rules and Compliance
Calculating Target Measurement Uncertainty
Types of Decision Rules
Target Measurement Uncertainty in the Analytical Target Profile
Bias and Uncertainty in a Procedure
ATP and Key Performance Indicators
Measurement Uncertainty
Example
Conclusion
ESTABLISHMENT OF MEASUREMENT REQUIREMENTS - PERFORMANCE-BASED SPECIFICATION
Introduction
Intended Purpose
Identification
Assay
Impurities
Limit Tests
Quantitative Tests
Summary
METHOD PERFORMANCE CHARACTERISTICS
Introduction
Precision
Accuracy and Range
Specificity
Linearity
Detection and Quantitation Limit
Glossary
METHOD DESIGN AND UNDERSTANDING
Introduction
Analytical Quality by Design and Robustness Investigations
Case Study: Robustness Investigations
System Suitability Tests
METHOD PERFORMANCE QUALIFICATION
Introduction
Case Study: Qualification of an HPLCMethod for Identity, Assay, and Degradation Products
Design and Qualification of a Delivered Dose Uniformity Procedure for a Pressurized Metered Dose Inhaler
Implementation of Compendial/Pharmacopeia Test Procedures
Transfer of Analytical Procedures
CONTINUED METHOD PERFORMANCE VERIFICATION
Introduction
Routine Monitoring
Investigating and Addressing Aberrant Data
Continual Improvement
Index
Details
| Erscheinungsjahr: | 2014 |
|---|---|
| Fachbereich: | Theoretische Chemie |
| Genre: | Chemie, Mathematik, Medizin, Naturwissenschaften, Technik |
| Rubrik: | Naturwissenschaften & Technik |
| Medium: | Buch |
| Inhalt: | ForewordANALYTICAL VALIDATION WITHIN THE PHARMACEUTICAL LIFECYCLEDevelopment of Process and Analytical Validation ConceptsAlignment between Process and Analytics: Three-Stage ApproachPredefined Objectives: Analytical Target ProfileAnalytical Life CycleAN |
| ISBN-13: | 9783527335633 |
| ISBN-10: | 3527335633 |
| Sprache: | Englisch |
| Herstellernummer: | 1133563 000 |
| Redaktion: |
Ermer, Joachim
Nethercote, Phil W. |
| Auflage: | 2. Aufl. |
| Hersteller: | Wiley-VCH |
| Verantwortliche Person für die EU: | Wiley-VCH GmbH, Postfach:10 11 61, D-69469 Weinheim, wiley.buha@zeitfracht.de |
| Abbildungen: | 140 SW-Abb., 10 Farbabb., 100 Tabellen |
| Maße: | 250 x 173 x 25 mm |
| Von/Mit: | Joachim Ermer (u. a.) |
| Erscheinungsdatum: | 14.10.2014 |
| Gewicht: | 0,95 kg |
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