It’s Official – A New Guidance Document for Analytical Method Validations

Last week, the FDA released a Guidance entitled Analytical Procedures and Method Validations for Drugs and Biologics (here)  which replaces the 2000 Draft Guidance document “Analytical Procedures and Method Validation” and the 1987 Guidance document “Guidelines for Submitting Samples and Analytical Data for Methods Validation”. The new Guidance covers the required information relating to submissions/supplements for analytical methodologies and analytical method validations for drug substances and drug products covered in new drug applications (NDAs), abbreviated new drug applications (ANDAs) regulatory submissions, biologics license applications (BLAs).

The document provides guidance for analytical method development where it states that development data should be included within the method validation section of the filing if the data supports the validation. This is the case for robustness which should be assessed during the early stages of method development.

Analytical procedures will include sufficient detail to allow a competent analyst to follow and obtain acceptable results. The procedure will contain the following: Principles/Scope; Apparatus/Equipment; Operating Parameters; Reagents/Standards; Sample Preparation; Standards Control Solution Preparation; Procedure; System Suitability; Calculations; Data Reporting.

Included within the Guidance are expectations for the use and characterization of reference standards along with reference standard comparability studies when qualifying a new lot of an existing reference standard.

The Guidance includes recommendations for when utilizing statistics for the analysis of analytical method validation data.

Lifecycle Management of Analytical Procedures is discussed, which includes trend analysis of method performance. When revising analytical methods there is a recommendation to use reserve samples for comparative studies. For questions in applying the new Guidance or on validation principles or analytical methods, please contact Jim Davidson at j.davidson@LachmanConsultants.com.