Recording from Tuesday, November 17, 2020
The presenters provided 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.
- Define minimum qualification criteria for an excipient-certification SO and CB.
- Identify minimum information needed by excipient users to qualify a SO as well as the CBs who conduct and issue excipient GMP certificates and audit reports.
- Become familiar with content and use of the template associated with the Guide.