Thursday, 12 November 2015

FDA revised guidance for analytical method validation – reviewed

Analytical method validation is an important requirement to support the package of information submitted to international regulatory agencies in support of new product marketing or clinical trials applications. Back in 1987, the US Food and Drug Administration (FDA) issued its first guidance on analytical methods. The document was subsequently revised in 2000 and, despite the advancement in analytical methods, there were no further updates until 2014, when a new draft was issued for public comment. Following the period of review, in July 2015, the FDA issued a new version of the guidance. The third edition is titled Analytical Procedures and Methods Validation for Drugs and Biologics.

A new article assesses the main points and the key changes in the document.

The reference is:

Sandle, T. (2015) FDA issues revised guidance for analytical method validation, GMP Review, 14 (3): 8-10

For a copy please contact Tim Sandle

Posted by Tim Sandle