What is a GMP certificate and what is the difference between GMP certificates, certificates of medicinal product (CMPs, also called certificates of pharmaceutical products, CPPs) and certificates of suitability to the monographs of the European Pharmacopoeia (CEPs)?
What is a GMP certificate ?
A GMP certificate is a certificate issued following a GMP inspection, by the competent authority (A medicines regulatory authority in the European Union.) 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). Directives 2001/82/EC
and 2001/83/EC, as amended state that after every GMP inspection, and within 90 days of the inspection, a GMP certificate shall be issued to a manufacturer, if the outcome of the inspection shows that the manufacturer complies with GMP.
and 2001/83/EC, as amended state that after every GMP inspection, and within 90 days of the inspection, a GMP certificate shall be issued to a manufacturer, if the outcome of the inspection shows that the manufacturer complies with GMP.
CMPs are product-specific certificates issued by the competent authority that granted the marketing authorisation. The European Medicines Agency issues CMPs on behalf of the European Commission for centrally authorised products.
CMPs are issued in the context of the World Health Organization certification scheme on the quality of pharmaceutical products moving in international commerce, to confirm the marketing-authorisation status of the products. These certificates also confirm the GMP compliance status of the manufacturing sites. CMPs are mainly used by companies to support applications to export their pharmaceutical products to countries with less-developed regulatory systems.
CEPs are certificates issued by the European Directorate for the Quality of Medicines and Healthcare (EDQM) to confirm that a certain active substance is produced according to the requirements of the relevant monograph of the European Pharmacopoeiaor of the monograph on transmission spongiform encephalopathies.
(EDQM) to confirm that a certain active substance is produced according to the requirements of the relevant monograph of the European Pharmacopoeiaor of the monograph on transmission spongiform encephalopathies.
CEPs can be used by companies when submitting an application for marketing authorisation, and replace much of the documentation required for the active substance in the marketing-authorisation dossier. GMP inspections of active-substance manufacturers can be requested by EDQM in the context of the CEP certification scheme.
Source: EMA
Published by: Knowledge
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