Guidance for Industry on Heparin Released by FDA, Bookend to Heparin Scandal

Posted 10 February 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released new draft guidance for industry on ensuring that a company's heparin supply meets quality standards. The draft guidance, Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality, comes just four years after tainted Chinese-sourced Heparin killed dozens of US citizens.

The draft guidance aims to "help API manufacturers, pharmaceutical and medical device manufacturers of finished products, repackers, and others to better control their use of crude heparin that might contain oversulfated chondroitin sulfate (OSCS) or non-porcine material (especially ruminant material) contaminants."

The draft guidance recommends that manufacturers test and confirm the species origin of each batch of crude heparin, test each batch of heparin for OSCS, have a firm grasp of the entire supply chain for the sourced heparin API, utilize ICH Q7 controls, and reject and dispose of any crude heparin found to contain any amount of OSCS.

Comments are due 60 days after the date of publication.

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