A few interesting soundbites from ExcipientFest 2010, which is being presented this year by IPEC, and held in San Juan, Puerto Rico.
Dale Carter, who a few years ago compared not knowing your supply chain to using a toothbrush found in a public restroom, used the metaphor of the Big Bad Wolf in his talk this year on supply-chain secruity. He pointed out that you may feel safe in a straw house because you can’t see what’s out there (the wolf, ready to blow your house down). It’s important, he said, to understand the full picture of your supply chain–just seeing the CoA, the label marked “USP”, an ID test result, an audit, etc., is not enough. It’s important to understand everything about your supply chain–your house and all its surroundings, if you will.
On the topic of shared audits, Irwin Silverstein of IPEA and Eric Berg, representing the Rx-360 consortium, pointed out that the time is now ripe for industry to share audits during their session. The difference now compared to nearly 10 years ago when IPEA started its excipient audit program, is that Congress is now asking tough questions about why excipient suppliers are not required to be audited, about why FDA does not regulate excipients in the same manner it regulates APIs, and so forth. The fact is, Americans have witnessed first hand the effects of heparin and melamine contamination, and now there is question as to whether the children’s medication recall (Tylenol, Motrin, Zyrtec, etc) involves an excipient (news isn’t out yet on that point). The time for not sharing information–and audits–is essentially coming to an end. FDA’s transparency intiative is a case in point.