Another scandal involving melamine adulteration of milk hit China this month as referenced by the Rx-360 website.
Because of similar incidents with other raw materials, this represents a not so subtle reminder as to why the FDA issued its guidance document for assessing melamine risk in pharmaceutical components, and further cited testing methods for that purpose. Methods for cleaning up complex samples to be tested have also been published.
I think all reputable suppliers applaud the FDA intent. Clearly, it is in everyone’s interest that the integrity of the supply chain be maintained. But, like many things, sometimes the devil is in the details.
The Coalition for the Monitoring of Melamine Adulteration (IPEC Americas, IPEC Europe, PhRMA, GPhA, CHPA, SOCMA) did issue a response citing some concerns and recommendations that should be considered prior to implementation (Download IonConsolidatedCommentsonMelamineGuidance9-9-2009(Final)) IPEC further provides suggested templates to request information from suppliers in an attempt to standardize both the requests and responses with the intent of minimizing non-value added work.
Given the new situation, it is not surprising that suppliers and customers alike are feeling their way forward as to how to best address the FDA’s guidance. We’ve surveyed the scene and have the perhaps unique perspective of being both a supplier and a customer for a wide variety of raw materials used in a host of industries – not just the pharmaceutical industry. Certainly, the responses we’ve seen are mixed too.
Accordingly, we’ve tried to take a risk-based approach that helps us to concentrate our testing efforts on those materials that would have the biggest risk of melamine contamination and that would otherwise go undetected, and those materials that would have the biggest potential impact on product safety.
Our Risk Assessment concept follows. I would like to receive feedback on this from our customers, suppliers and the market generally.
Don't be shy in weighing in.
Posted by Bruce Lehr Jan 13, 2010