FDA Guidance for Drug Components at Risk for Contamination

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FDA issued the subject guidance document in August 2009 to address the potential risk of melamine contamination in pharmaceutical components. This may seem like old news, but with the focus on the supply chain, there is more and more responsibility being placed on the finished drug manufacturer to ensure the incoming quality of components and the outgoing quality of the drug product. FDA considers the presence of melamine in a drug to render that drug adulterated. Melamine contamination was responsible for the tainted pet food incident in 2007 and the contaminated infant formula tragedy in China in 2008. FDA is suggesting that industry determine if their components are at risk, and if so, that the manufacturer of finished drug product test for melamine contamination using methods recommended by FDA.

Read more about these methods here.

FDA expects manufacturers to know and monitor their supply chain and obtain certification from at risk component manufacturers that the components have been tested for the absence of melamine contamination.

This guidance document has a list of at risk components, that is not all inclusive, and still requires manufacturers to perform risk assessment of their components on an individual basis.

Download the guidelines (pdf).