Should There Be Mandatory Audits for All API Suppliers?

Should There Be Mandatory Audits for All API Suppliers?

November 14th, 2012 // 2:25 pm @


A European trade group that represents chemical manufacturers believes that European Union efforts to safely oversee active pharmaceutical ingredient production in other regions is sorely lacking and now wants inspections of all API manufacturing facilities around the world to become mandatory.

The European Fine Chemicals Group argues that recent legislative efforts, including those aimed at reducing the supply of counterfeit medicines, have failed. Inspections may cost about $3.3 million over a three-year period, but this “would be a small price to pay to guarantee the quality of APIs meets the EU standard, irrespective of its global source,” the group says.

The recommendation comes amid heightened concern over the global supply chain for pharmaceuticals as more drugmakers rely on low-cost suppliers, especially those located in countries such as China, where the heparin scandal originated and led to 81 deaths in 2007 and 2008 (back story).

Earlier this year, for instance, the State Food and Drug Administration in China found that 254 pharmaceutical companies, or 12.7 percent of all capsule makers, turned out unsafe capsules in a recent month-long inspection. Of the 11,561 batches of drugs tested, 5.8 percent were found to contain excessive levels of chromium (see this).

In a position paper issued this week, the EFCG maintains that a recent directive aimed counterfeiting actually “accepts that the continued risk to EU citizens is the normal situation, adopting the safe solution only as an exception, to be used when there is a lack of key medicines needing APIs from non-EU sources.”

The group worries that the directives do not require inspections of API facilities outside Europe and, instead, require importers to assure quality and compliance with good manufacturing practices through audits. “There is a big difference in the quality of an audit and an inspection performed by a national authority,” the ECFG writes.

“Most current suppliers in such third countries will take a very long time to achieve EU standards of API manufacturing and, until they do, the risk control mechanisms to protect the EU public – a written confirmation and/or an audit by a Marketing Authorisation Holder – are less reliable than that provided by an inspection by an EU, or equivalent, authority” (here is the EFCG position paper).

Whether mandatory inspections will occur remains to be seen, of course. The supply chain is certainly a problem, but coordinating such an effort may be challenging. And the cost estimates of $3.3 million annually may well prove to be insufficient, given the difficulties in ferreting out suppliers in some countries and the number of ‘feet on the ground’ required to conduct inspections and monitoring.

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