The regulation of Pharmaceutical Excipients

Abstract

Pharmaceutical excipients are vital components of drug formulations and are generally considered pharmacologically inert. Control of excipient manufacturing and distribution is now considered a key priority by regulatory authorities and pharmaceutical manufacturers, because adulteration of pharmaceutical excipients has resulted in adverse effects in patients. Furthermore, with the emergence of novel excipients and delivery systems, better quality and supply control of pharmaceutical excipients becomes increasingly important in the context of in vivo performance. Recognizing the critical role that excipients play in pharmaceutical dosage forms necessitates that excipient suppliers meet the quality requirements of the pharmaceutical industry and the pharmaceutical industry as a whole must work to assume integrity of the supply chain.