Growing security concerns
Expectations for auditing excipient distributors have grown significantly in recent years. In June 2009, FDA held a conference on economically motivated adulteration (EMA). FDA's working definition of EMA is "the fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production (i.e., for economic gain)." EMA is a concern for excipients, in particular, because their supply chain from the manufacturer to end-user frequently involves multiple distributors and, thus, weakens their supply-chain security. FDA investigators also have recently been inspecting supplier-qualification programs at pharmaceutical manufacturers with the expectation that drug manufacturers qualify their distributors and the excipient manufacturers they represent. Industry expressed great interest in the qualification of distributors at two recent conferences, IVT's November 2010 Life Sciences Forum Supplier Audits and the American Society for Quality's January 2010 Northeast Pharmaceutical GMP/Quality Conference. Attendees discussed how certain audit tools could help assess distributors and their excipient suppliers.The IPEC–Americas audit guide supports the IPEC GDP Guide for Pharmaceutical Excipients issued in 2006. The audit guide provides open-ended questions that are meant to help the auditor begin a dialogue with the distributor and thereby enable the auditor to obtain objective evidence from which to establish conformance of the distributor to applicable provisions of the GDP guide. The audit guide also provides information on how to develop an excipient distributor certification program (see section below).