Analytical Procedure and Method Validation Guidance

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] In late July, FDA released a final guidance on “Analytical Procedures and Methods Validation for Drugs and Biologics.” FDA had issued a draft of the guidance in February 2014. The guidance updates the draft guidance FDA put out in 2000, which, in turn, was an update of its 1987 guidance on “Submitting Samples and Analytical Data for Methods Validation.” The 2015 guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. The guidance applies to new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and their supplements, but not to investigational new drug applications (INDs). Changes from the 2014 draft include clarifications regarding: ● appropriate reference standards and materials ● analytical method validation ● verification protocols, and ● differing expectations for methods referenced in BLAs.
[/membership]