1st Edition

Handbook of Analytical Validation

By Michael E. Swartz, Ira S. Krull Copyright 2012
    220 Pages 51 B/W Illustrations
    by CRC Press

    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

      Biography

      Michael E. Swartz, Ira S. Krull

      "The authors are to be congratulated on producing a concise, readable and informative book. It is a really useful reference asset covering current regulatory requirements on the validation of new or modified analytical methods from a practical viewpoint. I have seen books of almost twice the size containing half the information. This book should be an integral part of all drug and biotechnology laboratories for both training staff and for comprehensive advice on how to deal with a very wide range of specific issues relating to AMV."
      —www.chemistryworld.org 1 November 2012 1 Chemistry World 163