@Risk

The US Food and Drug Administration has released new recommendations designed to help pharmaceutical manufacturers better control the use of at-risk components that may be contaminated with melamine.

The 8-page industry guidance document, Pharmaceutical Components at Risk for Melamine Contamination, includes a list of potential at-risk compounds —several of which are rather commonplace (gelatin, guar gum, lactose, e.g.).

The FDA also outlines these specific recommendations:

• Manufacturers of finished pharmaceuticals should test for melamine in at-risk components before they are released for use in the manufacture or preparation of the drug products.

• Manufacturers of finished pharmaceuticals should “know and monitor” their supply chain for any at-risk components. According to the FDA, that includes knowing the identity and role of the actual manufacturer of such components and any repackers and distributors who handle the components before receipt by the manufacturer. Manufacturers should also obtain certification that these components are tested for the absence of melamine and audit their component suppliers to ensure compliance.

• Likewise, the FDA also advises distributors of finished pharmaceuticals to obtain certification by the manufacturer that the products are tested for the absence of melamine contamination.

Of course, all of these suggestions are fundamental to a well-aligned supply chain. But, the heparin contamination scandal last year showed that pharmaceutical companies can be unbelievably lax regarding basic risk management strategies, such as on-site inspection of  their suppliers.

Melamine is a common ingredient in plastics, fabrics, glues, housewares, and flame retardants. But, you don’t want to ingest it. Melamine ingestion is linked to reproductive damage, serious kidney problems, and death.

Back in 2007, the compound was at the center of a pet food recall. Then, in 2008 melamine-contaminated infant formula killed several babies in China and sickened thousands (nearly 300,000 by some estimates) more.

In China, melamine has been an adulterant in feedstock and milk because it’s a relatively inexpensive compound that can mimic protein in certain simple protein tests.