The presenter discussed what a pharmaceutical company should do when their excipient supplier won’t allow an on-site audit. For various reasons, excipient manufacturers are not always able to accommodate site audits by all their customers. However, the FDA encourages - and may soon expect - that pharmaceutical companies include site audits as a part of their excipient supplier qualification process. Currently site audits of excipient manufacturers are encouraged by the Falsified Medicines Directive, which has recently been adopted as guidance by PIC/s. So, what is a pharmaceutical company to do?
This webinar introduced several alternatives to 2nd party audits that should satisfy current and emerging regulations in this area.