Handbook of Analytical Validation  book cover
1st Edition

Handbook of Analytical Validation

ISBN 9780824706890
Published April 24, 2012 by CRC Press
220 Pages 51 B/W Illustrations

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Book Description

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.

    Table of Contents

    Introduction to Analytical Method Validation
    The Drug Development Process
    FDA Hierarchy and Organization
    The International Conference on Harmonization
    AMV Guidance
    The Validation Process

    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
    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

    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

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    "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