Early in January 2011, the International Pharmaceutical Excipients Council of the Americas (IPEC–Americas) updated its 2000
GMP Audit Guideline for Distributors of Bulk Pharmaceutical Excipients and renamed it the IPEC–Americas Good Distribution Practices Audit Guide for North American Distribution of Pharmaceutical
Excipients. Although the new good distribution practice (GDP) audit guide is meant for distributors, brokers, and traders
of excipients in North America primarily, it also can be a resource for the audit of distributors worldwide. For the purposes
of this article, distributor is defined as encompassing the following: distributors who take possession of an excipient and may conduct a range of activities
from repackaging and storage through warehousing and shipping; brokers who arrange for a transaction between an excipient
manufacturer and an excipient user but never take physical possession of the excipient; and traders who contract with the
excipient user before finding a source of the excipient for the pharmaceutical manufacturer and also never takes physical
possession of the excipient.
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).