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Aims of the Programme
The programme is aimed to check compliance with both current Good Manufacturing Practices (GMP)* and the Certificate of Suitability (CEP) application dossier (and any updates) at the manufacturing/distribution sites covered by CEPs. The EDQM Certification Division is responsible for the organisation of the inspections and their follow-up, including the implementation of any subsequent action regarding the related CEPs and communication with the concerned authorities. The annual programme of inspection is elaborated based on prioritisation in accordance with the EMEA/EU recommendations** and is adopted by the Certification Steering Committee.
*Vol 4 of the Rules Governing Medicinal Products in EU
**(trigger doc. Ref. EMEA/INS/GMP/3351/03/Rev 5 - Compliance of Community Procedures on Inspections and Exchange of Information)
The Procedure
The EDQM's Certification Division is responsible for co-ordinating any inspection. The inspections are run by official inspectors from the European Pharmacopoeia member states. For inspections in non-European Pharmacopoeia member states, local official inspectors are invited.
When the conclusion of the inspection is favourable, an attestation of compliance with GMP and CEP dossier is issued by the EDQM.
In the case of major/critical deficiencies notices during the inspection, the corresponding CEPs may be suspended. In such case, the suspension is reported on the EDQM's website and all the authorities concerned are immediately informed so that any necessary action regarding related marketing authorisation(s) can be taken. The holder has to inform all their customer(s). The suspension will end only when the company takes satisfactory corrective actions and the implementation of the corrective actions is confirmed by a re-inspection.
Fees
The fee for an inspection is 5,000 Euros. An invoice will be sent to the applicant with the letter of notification of the inspection. Full payment is due within 30 days of the date of the invoice. Applicants can pay by credit card online via the EDQM Store, by bank transfer and cheque.
How do I pay EDQM invoices?
7 allée Kastner, CS 30026, F67081 Strasbourg, France - Tel. +33 (0)3 88 41 30 30 - Fax +33 (0)3 88 41 27 71
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