Tuesday, November 17, 2020 – 9:30am EST – 2:30pm GMT
The presenters will provide an overview of the soon-to-be-published IPEC GMP Certification Scheme and Certification Body Qualification Guide for Pharmaceutical Excipients.
Lack of a unified industry approach to certification body qualification has resulted in pharmaceutical companies independently developing their own approach, which is subject to scrutiny during regulatory agency inspections. This Guide facilitates a consistent approach by excipient users to the qualification of an excipient-certification scheme owner (SO) and certification body (CB). This webinar will present the minimum criteria for the qualification of an excipient-certification SO and CB, which should be useful to excipient users in their own qualification of the GMP certificates issued by a CB.