New edition of the gold standard in the field of pharmaceutical analysis, extensively updated to include the new ICH Guidelines Q2 and Q14
Following an all-encompassing lifecycle approach to analytical procedures in pharmaceutical analysis, Method Validation in Pharmaceutical Analysis provides hands-on information for readers involved in development, validation, and continued maintenance and evaluation of analytical procedures in pharmaceutical analysis.
This newly revised and updated Third Edition includes much-needed interpretation of the most recent ICH guidelines for validation and method development, as well as recent publications of the USP Validation & Verification Expert Panel on Analytical Procedure Lifecycle Management and the activities of the British Pharmacopeia AQbD Working Party. It also addresses trending topics in the field such as data integrity and continuous monitoring of analytical performance.
Written by a team of highly qualified pharmaceutical professionals, Method Validation in Pharmaceutical Analysis includes information on sample topics such as: - Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle - Continued HPLC performance qualification, analytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical procedures - Method selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategy - Implementation of compendial/pharmacopeia test procedures, transfer of analytical procedures, and the lifecycle approach to transfer of analytical procedures
Completely comprehensive in coverage, Method Validation in Pharmaceutical Analysis is an essential reference for scientists, researchers, and professionals in the pharmaceutical industry, analytical chemists, QA officers, and public authorities tasked with relevant regulatory responsibilities.
Following an all-encompassing lifecycle approach to analytical procedures in pharmaceutical analysis, Method Validation in Pharmaceutical Analysis provides hands-on information for readers involved in development, validation, and continued maintenance and evaluation of analytical procedures in pharmaceutical analysis.
This newly revised and updated Third Edition includes much-needed interpretation of the most recent ICH guidelines for validation and method development, as well as recent publications of the USP Validation & Verification Expert Panel on Analytical Procedure Lifecycle Management and the activities of the British Pharmacopeia AQbD Working Party. It also addresses trending topics in the field such as data integrity and continuous monitoring of analytical performance.
Written by a team of highly qualified pharmaceutical professionals, Method Validation in Pharmaceutical Analysis includes information on sample topics such as: - Data governance, data integrity, and data quality, as well as analytical instrument qualification and system validation lifecycle - Continued HPLC performance qualification, analytical target profile, decision rules and fitness for intended use, and performance characteristics of analytical procedures - Method selection, development, and optimization, multivariate analytical procedures, and risk assessment and analytical control strategy - Implementation of compendial/pharmacopeia test procedures, transfer of analytical procedures, and the lifecycle approach to transfer of analytical procedures
Completely comprehensive in coverage, Method Validation in Pharmaceutical Analysis is an essential reference for scientists, researchers, and professionals in the pharmaceutical industry, analytical chemists, QA officers, and public authorities tasked with relevant regulatory responsibilities.
Table of Contents
Analytical Validation within the Pharmaceutical Lifecycle ManagementData Integrity
Analytical Equipment Qualification
- An Integrated and Harmonized Approach to Analytical Instrument Qualification and Computerized System Validation
- Efficient and economic HPLC Performance Qualification
Establishment of Measurement Requirements -
Analytical Target Profile and Decision Rules
Establishment of Measurement Requirements -
Performance Based Monographs
Establishment of Measurement Requirements -
Analytical Target Profile
Method Performance Characteristics
Method Design and Understanding
ICH Q14: Analytical Development
- Method Selection, Development & Optimisation
- Analytical Quality by Design and Robustness Investigations
- Case Study Robustness Investigations
- System Suitability Tests
Risk assessment and Analytical Control Strategy
Method Qualification
ICH Q2(R2): Validation of analytical procedures
Case Study: Validation of an LC-method for Identity, Assay, and Related Impurities
Design and Qualification of a Delivered Dose Uniformity Procedure for a Pressurised Metered Dose Inhaler
Case Study: Bioassay
Implementation of Compendial/Pharmacopeia Test Procedures
Transfer of Analytical Procedures
Continued Method Performance Verification
