Conclusions
Regulatory expectations regarding the quality of UFH have increased since the global heparin crisis of 2008. Industry has
witnessed modernization of pharmacopeial methods that demand higher criteria for all quality attributes. Orthogonal tests
have been implemented to identify heparin and to demonstrate lack of contaminants. At the workshop, USP and FDA jointly announced
their intent to further revise heparin monographs to ensure the continued supply of safe and effectve heparin for patients.
USP will update heparin stakeholders about the status of the monograph revisions and will ensure sufficient time for a public
evaluation of the procedures, specifications, and implementation date.
Anita Y. Szajek, PhD, is a senior scientific liaison, Tina S. Morris, PhD, is vice-president of biologics & biotechnology, both at the US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790,
tel. 301.816.8325, aey@usp.org
References
1. USP Heparin Hot Topics Page,
http://www.usp.org/hottopics/heparin.html, accessed Aug. 27, 2009.
2. USP Heparin Workshop Page,
http://www.usp.org/meetings/workshops/heparinWorkshop2009.html, accessed Aug. 27, 2009.
3. FDA, Information on Heparin (2009),
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM112597, accessed Aug. 27, 2009.
4. M. Guerrini et al., "Oversulfated Chondroitin Sulfate Is a Contaminant in Heparin Associated with Adverse Clinical Events,"
Nature Biotechnol.
26 (6), 669–675 (2008).
5. EMEA, Guideline on Similar Biological Medicinal Products Containing Low-Molecular-Weight-Heparins (London, March 2009).
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