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.
US FDA
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
ICH - Guidance for Industry
Q2A - Text on Validation of Analytical Procedures
ICH - Guidance for Industry
Q2B - Validation of Analytical Procedures - Methodology
OTHER Official Guides
EURACHEM
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
NATA
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