Qualification of excipients for use in pharmaceuticals

IPEC has published Qualification of Excipients for Use in Pharmaceuticals detailing processes for developing and sourcing excipients and discusses issues that must be resolved for development of a commercial agreement. The document is divided into the Excipient Supplier's Process, the Users Process, and concludes with the Negotiation Process. The guideline provides a framework for suppliers and users of excipients to better understand the barriers to the introduction of new excipients and alternate sources of existing excipient grades. This dialogue provides for easier resolution of technical, safety, and regulatory issues concerning excipients. in December 2008, IPEC published Qualification of Excipients for Use in Pharmaceuticals. This guide of international applicability details processes for developing and sourcing excipients from the perspective of both the excipient supplier and user and provides a discussion of the issues that must be resolved to allow for development of a commercial agreement between the two parties. This article presents an overview/summary of the IPEC guide. IPEC is an international industry association formed in 1991 by manufacturers and end-users of excipients. It is an association comprising four regional pharmaceutical excipient industry associations covering North America, Europe, China and Japan (which are known respectively as IPEC-Americas, IPEC Europe, IPEC-China and JPEC). IPEC's objective is to contribute to the development and harmonisation of international excipient standards, the introduction of useful new excipients to the marketplace, and the development of best practice and guidance concerning excipients.