Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook:



•Contains practical, up-to-date guidelines for analytical method validation
•Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications
•Covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment
Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.

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