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All come with 10+ Best Practice Documents: SOPs, Checklists, Examples

 

Validation of Analytical Methods and Procedures

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

Recorded

February 28, 2008

Transfer of Analytical Methods and Procedures

FDA Requirements, Strategies and Tools for Implementation

Recorded

 

Verification of Compendial Methods

Understanding the New USP Chapter <1226>

Recorded

 

System Suitability Testing in Compendial Chromatographic Methods

Understanding and Implementing Recent Changes of USP and EP

Recorded

 

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