Following a meeting last week, the panel proposed the addition of a heparin molecular weight determination procedure, as well as ramped-up testing for the presence of OSCS, and more control over nucleic acid impurities.
If the planned changes go through, this will be the third lot of revisions to QA/QC (quality assurance and quality control) writ for the controversial blood thinner since it made the first changes in 2008, when the drug first came into question.
The adulteration of heparin batches with the cheaper substance over-sulfated chondroitin sulfate (OSCS), led to the deaths of 100 US patients. Supply chain issues were traced back to manufacturers in China.
“A secure and safe drug supply is something that the public has come to expect and rightfully so,” said Roger Williams, USP’s CEO.
“Quality standards play a significant role in the overall safety net of regulations and controls that protect medicines in the US. Developing and continuously improving standards based on the best science available are paramount.”
USP is now accepting public comments on the proposed changes.
Reform
Since the scandal first hit – when the regulator was found to have made no inspections of the 11 Chinese heparin firms for 20 months – the FDA US FDA (Food and Drug Administration) has waded deeper into Chinese manufacturing inspection.
And it seems the news is just part of the organisation’s increasingly tight grip on heparin supply. In February, the regulator issued an import alert against 22 heparin makers in China, allowing it to seize products from the companies without physical inspections.
In the same breath, the FDA called upon companies to audit heparin suppliers themselves through a new draft guidance.
However many seemed unimpressed by the changes, with Celsus Merck branding them unclear and ambiguous.
The latest draft guidance was prompted by the FDA, which requested the USP to draft the document.