ABSTRACT
A Good Manufacturing Practice (GMP) certificate is a certificate issued, following a GMP inspection, by the competent authority responsible for carrying out the inspection, to confirm the GMP compliance status of the inspected site. GMP certificates are site specific, but can be restricted to particular activities depending on the scope of the inspection (e.g., manufacturing activities related to a specific product). CEPs are certificates issued by the European Directorate for the Quality of Medicines (EDQM) to confirm that a certain active substance is produced according to the requirements of the relevant monograph of the European Pharmacopoeia or of the monograph on TSE. GMP for inspections of active substance manufacturers can be requested by EDQM in the context of the CEP certification scheme. The EDQM allows raw material manufacturers to submit and secure approval for their active pharmaceutical ingredients besides the approval of the finished products; such approvals are not available in the jurisdictions of the FDA.
