FDA Guidance for Industry: Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality
Title:
FDA Guidance for Industry: Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291390.pdf
Content:
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