Handbook of Analytical Validation: 1st Edition (Hardback) book cover

Handbook of Analytical Validation

1st Edition

By Michael E. Swartz, Ira S. Krull

CRC Press

220 pages | 51 B/W Illus.

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Hardback: 9780824706890
pub: 2012-04-24
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pub: 2012-04-24
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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.


"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

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

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacy
SCIENCE / Chemistry / General
SCIENCE / Chemistry / Analytic