The European Directorate for the Quality of Medicines & HealthCare (EDQM) establishes and provides official standards for the manufacture and quality control of medicines in all the signatory states of the ‘Convention on the Elaboration of a European Pharmacopoeia’ (an international treaty adopted by the Council of Europe).
As part of the quality evaluation programme for active ingredients and excipients used in the manufacture of medicines, the EDQM also runs an inspection programme for CEP (Certificate of Suitability) holders, targeting their manufacturing and/or distribution sites. A CEP applicant must also agree to comply with the relevant EU Good Manufacturing Practice guidelines and to accept an on-site inspection at any time at the request of the EDQM.
Metina provides complete support for Inspection preparedness, overseeing the actual inspection and facilitating the same, verification of technical observations with inspectors and query response.
Additionally we provide complete services for API Regulatory.