Drugmakers need to pay closer attention to the quality and source of their excipients as regulators are likely to enforce new quality standards that trade groups are drafting, a former chair of the International Pharmaceutical Excipients Council (IPEC) says. IPEC is working with regulators, industry, stakeholders and academia to develop uniform good manufacturing practices (GMPs) for excipients, David Schoneker, director of global regulatory affairs at excipient maker Colorcon, said.
Washington Drug Letter