IPEC Federation Publishes Position Paper on Third Party Audit and Certification Programmes

Problem statement

Pharmaceutical manufacturers are facing increased regulatory demands to ensure that the raw materials used in their medicines – including excipients – are safe, of high-quality, and sourced from reputable suppliers who adopt appropriate good practices. In turn, excipient suppliers are facing escalating numbers of site audits and related information requests to ensure their facilities and products meet the expectations of regulators. The audit burden on both parties is becoming insupportable, with many suppliers declining audits or only agreeing to host audits on a commercial basis.