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Validation of Analytical Methods and Procedures

Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance


February 28, 2008

Transfer of Analytical Methods and Procedures

FDA Requirements, Strategies and Tools for Implementation



Verification of Compendial Methods

Understanding the New USP Chapter <1226>



System Suitability Testing in Compendial Chromatographic Methods

Understanding and Implementing Recent Changes of USP and EP



Analytical Methods Validation
FDA and International Guidelines and Private Publications

Analytical method validation is the process to confirm that the analytical procedure employed for a specific test is suitable for its intended use. FDA regulations such as GMP, GLP and GCP and quality standards such as ISO17025 require analytical methods to be validated before and during routine use. There are no specific regulations on method validations but the FDA, other agencies and industry task forces have developed guidelines for method validation. This site has links to such guidelines.



FDA Guidance (draft)

Analytical Procedures and Methods Validation


FDA Policy guide

Requesting Methods Validation for Abbreviated New Drug Applications (ANDAs)


FDA Guidance

Bioanalytical Method Validation


FDA Guidance

Mass, Spectrometry for Confirmation of the Identity of Animal Drug Residues, Draft


FDA Guidance

Guideline for Submitting Samples and Analytical Data for Methods Validation


FDA Guidance

Protocol for the Conduct of Method Transfer for Type C Medicated Feed Assay Methods



ICH - Guidance for Industry

Q2 (R1) - Validation of Analytical Procedures: Text and Methodology


ICH - Guidance for Industry

Q2B - Validation of Analytical Procedures - Methodology

OTHER Official Guides



The Fitness for Purpose of Analytical Methods

Probably the most detailed official document for method validation


EMEA Guide

Residues: Guidance for generating and reporting methods of analysis in support of pre-registration data requirements for Annex II (part A, Section 4) and Annex III (part A, Section 5) of Directive 91/414


US EPA Guide

Guide to Method Flexibility and Approval of EPA Water Methods


TGA Guide (Australia)

Starting Material Analytical Procedure Validation for Complimentary Medicines

March 2006


Technical Note #17 - Guidelines for the Validation and Verification of Chemical Test Methods
April 2009


IUPAC Technical Report
Harmonized Guidelines for Single Laboratory Validation of Methods of Analysis

Pure Appl. Chem., Vol. 74, No. 5, pp. 835–855, 2002


Private Publications


Private Publication

Validation of Analytical Assays and Test Methods for the Pharmaceutical Laboratory


Adjusting Conditions for a Routine Reversed-Phase HPLC Assay,
Part II: Changing Separation Conditions

LC/GC Magazine