IPEC Coalition/Rx360 MelamineTemplates

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Friday, December 11, 2009

IPEC-Americas (International Pharmaceutical Excipients Council) and the Coalition for the Monitoring of Melamine Contamination (CHPA, GPhA, IPEC, PhRMA, SOCMA) has partnered with RX-360 and generated a set of templates that can be used to communicate with suppliers and contract manufacturers and to gather information pertinent to material controls that are in place to prevent melamine contamination of raw materials. Surveying suppliers and contract manufacturers is a method that companies may choose to do as part of addressing the FDA Guidance to Industry: Pharmaceutical Components at Risk for Melamine Contamination. These MSWord templates can be downloaded by clicking on the links below and can be copied onto your company's letterhead. Sample Letter to Request Melamine Information from Suppliers.doc Sample Letter to Request Melamine Information from CMOs.docSample Form to Collect Melamine Information.doc It is recommended that excipient users utilize these templates when initiating a dialog with suppliers and contract manufacturers about the potential for melamine contamination in their products. It is important that you DO NOT just send these templates out to all of your suppliers for every excipient. This will just result in a lot of non-value work on everyone's part. Instead, this letter and form should ONLY be sent to suppliers of excipients which are either listed in the FDA's new guidance on Melamine or are materials where there may be some significant chance of there being a true risk such as the fact that the testing for the product contains a nitrogen assay. It is also recommended that excipient suppliers and distributors put together their responses in the same format as the Sample Form so that all the appropriate questions are adequately answered. This will help to expedite everyone's efforts and will minimize the need for multiple requests for the appropriate information to understand what is needed. These letters and the form are also available on the Rx-360 website at: http://www.rx-360.org/.