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5 Aug 2013

Rx-360's Summary of FDA's New Guidance for Industry, Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality

This guidance is published as a final version. The Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM) and Center for Devices and Radiological Health (CDRH) developed the guidance.
This guidance represents an ongoing focus on heparin arising out of the 2008 incidents involving adulteration of heparin with over-sulfated chondroitin sulfate (OSCS) which resulted in deaths in the US and several European countries. The guidance highlights the importance of testing for contamination in crude heparin in addition to conducting tests that are identified in USP for testing of heparin sodium API. The guidance provides context on the need for the guidance and the regulatory authority of FDA with regard to the sourcing and manufacture of heparin. Section III describes five recommendations that drug or device manufacturers should take if they receive crude heparin that will be manufactured into drug product or that will be used in medical devices. Establishing the species of origin and freedom from OSCS are the most critical elements expressed in the recommendations. 

To view or download the FDA Guidance, click here

To view or download the Rx-360 Summary, click here

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