Guidance for Industry: Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.

摘要

This guidance is intended to alert manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical and medical device manufacturers of finished products, repackers, and others to the potential risk of crude heparin contamination. This guidance provides recommendations that will help API manufacturers, pharmaceutical and medical device manufacturers of finished products, repackers, and others, to better prevent the use of crude heparin that might contain over-sulfated chondroitin sulfate (OSCS) or non-porcine ruminant material contaminants.