Handbook of analytical validation

Written for both the drug and biotechnology industries, this handbook has been carefully designed to instruct readers as to the current, regulatory requirements to correctly and properly validate a new or modified analytical method. The book contains the latest regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. It is designed for both small molecules in the conventional pharmaceutical industry, as well as for biopolymers derived from the biopharmaceutical industry. The book is designed to educate the reader into how to fully and correctly modify new or modified analytical methods to meet regulatory requirements.

Introduction to Analytical Method Validation. The Drug Development Process. FDA Hierarchy and Organization. The International Conference on Harmonization. AMV Guidance. The Validation Process. Training. Conclusion. Analytical Instrument Qualification. Components of Data Quality. The AIQ Process. Roles and Responsibilities. Software Validation and Change Control. AIQ Documentation. Instrument Categories. HPLC Method Development and Optimization with Validation in Mind. Introduction. HPLC Method Development Approaches. Method Goals. HPLC Method Development Instrumentation. Method Optimization. Method Validation Basics. Method Validation Guidelines. Terms and Definitions. Validation According to Method Type. Documentation. Robustness and System Suitability. 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. Setting Specifications and Investigating Out-of-Specification Results. 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. 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. Terms, Definitions and Responsibilities. Analytical Method Transfer Options. Documentation of Results: The AMT Report. Potential AMT Pitfalls. Implementing New Technology in a Regulated Environment. 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.