FDA Issues Draft Guidance on Heparin
The guidance is intended to alert manufacturers of APIs, pharmaceutical and medical device manufacturers of finished products, re-packers, and others on the potential risk of crude heparin contamination.
The US FDA has issued a Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.
The guidance is intended to alert manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical and medical device manufacturers of finished products, re-packers, and others on the potential risk of crude heparin contamination. The industry would need to revert with the comments by April 1.
The manufacturers have been asked to have better control on their use of crude heparin that might contain oversulfated chondroitin sulfate (OSCS) or non-porcine material which are ruminant material contaminants.
The development of methods set forth in the
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