FDA Draft Guidance: How to qualify Heparin Suppliers

The U.S. Food and Drug Administration (FDA) recently published a draft Guidance on Monitoring Crude Heparin for Quality. This document was created as a consequence of the OSCS (oversulfated chondroitin sulphate) contamination of heparin back in 2008. This draft guidance now intends to alert manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical and medical device manufacturers of finished products,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.

In this document, FDA sets out 5 recommendations:

1.) Origin:
The species origin of crude heparin in each shipment should be tested and confirmed before use.

2.) Testing:
Crude heparin should be tested for OSCS

3.) Audit:
The identity and role of the actual manufacturer of crude heparin and any repackers and distributors who handle crude heparin before receipt and use should be known. Manufacturers of drugs and medical devices containing heparin should audit their crude heparin suppliers and heparin API suppliers to ensure conformance to cGMP.

4.) Quality Control:
Controls as described in ICH Q7 should be implemented. Deviations and failures of quality, identity and purity should be fully and promptly investigated and resolved.

5.) Rejection and Notification:
Any crude heparin found to contain any amount of OSCS or ruminant material contaminant should be rejected for use, controlled, and properly disposed of, and the local FDA district office of the finding should be notified.

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

Compiled by:
Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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