Issue Date: June 25, 2013
Issued by: Center for Veterinary Medicine
Topic(s): Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality
Status: Final
Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality: Guidance for Industry
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.
Download the Guidance Document
