As posted in the PharmTech Talk blog, there is a good liklihood that the FDA will continue to raise the bar on the quality requirements associated with the manufacture and supply of excipients. Recent issues with heparin, melamine and now final products Tylenol, Motrin and Zyrtec all but assure this will occur.
Speakers at this year's IPEC meetings in Puerto Rico advocated that the time is now for us to really get into the details of our supply chain. Just seeing a CoA, the label marked USP, an ID test result, and an audit are not enough. It is important to understand everything about it.
Speakers from IPEA and from RX-360 also said it is well past time for companies to begin sharing results of supplier audits -- particularly for excipients. They noted that Congress is now asking tough questions about why excipients are NOTaudited like API suppliers. It can be expected that the public servants (& public) and the FDA will require much more transparency in the supply chain - and the time has arrived for sharing audit information.
Again, this greater emphasis on knowing what is in your raw materials and how these will effect your process & ultimately your product is the essence of our Raw Material Characterization Intitiative. I would strongly support the notion of shared audits in addition to enhanced selection and testing of all key raw materials.
Posted by Bruce Lehr May 9th 2010.
Comments