Handbook of Analytical Validation

ISBN: 9780824706890 出版年：2012 页码：218 Swartz, Michael E Krull, Ira S CRC Press

Introduction to Analytical Method Validation Introduction The Drug Development Process FDA Hierarchy and Organization The International Conference on Harmonization AMV Guidance The Validation Process Training Conclusion Analytical Instrument Qualification Introduction Components of Data Quality The AIQ Process Roles and Responsibilities Software Validation and Change Control AIQ Documentation Instrument Categories Conclusion HPLC Method Development and Optimization with Validation in Mind Introduction HPLC Method Development Approaches Method Goals HPLC Method Development Instrumentation Method Optimization Summary Method Validation Basics Introduction Method Validation Guidelines Terms and Definitions Validation According to Method Type Documentation Summary Robustness and System Suitability Introduction Robustness Studies for Method Validation Robustness Study Experimental Design Analyzing the Results Documentation and Reporting System Suitability Tests System Suitability Standards System Suitability Protocol Method Adjustments to Meet System Suitability Requirements Conclusion Setting Specifications and Investigating Out-of-Specification Results Introduction Guidance for Setting Specifications General Concepts for Developing and Setting Specifications Universal Tests/Criteria Specific Tests/Criteria: New Drug Substances Specific Tests/Criteria: New Solid Oral Drug Products Specific Tests/Criteria: New Oral Liquid Drug Products Specific Tests/Criteria: Parenteral Drug Products Decision Trees OOS Background Preventing OOS Results Identifying and Assessing OOS Test Results Investigating OOS Test Results Concluding the OOS Investigation Validation by Type of Method Introduction Validation of Impurity Methods Developing and Validating SIMs Developing and Validating Dissolution Procedures Bioanalytical Methods Validating Peptide Mapping Methods Cleaning Method Validation Analytical Method Transfer Introduction Terms, Definitions, and Responsibilities Analytical Method Transfer Options Documentation of Results: The AMT Report Potential AMT Pitfalls Implementing New Technology in a Regulated Environment Introduction Changes to an Approved Method What Constitutes a Change to a Method? Implement an Existing Standard Method Implement an Existing Standard Method with Adjustments Implement an Existing Standard Method with Changes Glossary of Terms Related to Chromatographic Method Validation Appendix 1 Example Method Validation Protocol