The EDQM inspection programme is an integral part of the Certification procedure and is elaborated in the context of the mandate given to EDQM by the European Commission in application of the Directives 2001/83/EC and 2001/82/EC as amended.
It is aimed to check compliance with both Good Manufacturing Practice (GMP)* and the Certificate of Suitability (CEP) application (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.
Every year, a programme of inspections is elaborated based on prioritisation, in accordance with the EU recommendations**. This programme is adopted by the Steering Committee for the Procedure for ‘Certification of Suitability to the Monographs of the European Pharmacopoeia'.
The inspections are carried out by official inspectors from the competent authorities in the EU/EEA, or in countries which have a Mutual Recognition Agreement with EU in GMP sector, as well as EDQM inspectors having the same qualification. For inspections carried out in non-EU/EEA/MRA member states, local official inspectors are invited as observers.
Interpreters may be used in some countries (e.g. China) to accompany the team of inspectors in order to ensure accurate communication with the company's staff. The EDQM does not appoint auditors to carry out inspections. Neither interpreters nor auditors can claim to be EDQM auditors.
* Vol. 4 of the Rules Governing Medicinal Products in EU.
** (trigger doc. EMA/INS/GMP/459921/2010 - Compilation of Community Procedures on Inspections and Exchange of Information).
Compliance: when the conclusion of an inspection is favourable, EDQM issues an attestation stating that the company has been inspected and found in compliance with GMP and with the information submitted in the CEP application. Additionally, a GMP certificate is granted by the inspector from the competent authority of EU/EEA member states having taken part in the inspection.
Non-Compliance: in the case of major/critical deficiencies noticed during the inspection, or in case of a refusal to be inspected, actions may be taken on the corresponding CEPs or applications for CEPs (suspension, cancellation, closure). Additionally, information of non compliance is issued by the inspector from the competent authority of EU/EEA member states. Suspensions and cancellations of CEPs are reported on the EDQM's website and to all concerned authorities so that the necessary action regarding related marketing authorisation(s) can be taken. Holders are also obliged to inform their customers. The suspension will only be lifted when the company takes satisfactory corrective actions and the implementation of the corrective actions is confirmed by a re-inspection.
Fees & Financial Provisions
The fee for an individual site inspection initiated by the EDQM depends on the number of days taken to carry it out. Typically, an inspection lasts 3 days and costs 5,000 Euros. For shorter durations, the fees are indicated in the document "Fees and Inspection costs". They are independent of the nature of the product and the type of manufacturing site being inspected.
For a site inspection requested by a company, the inspection fees are 9,000 Euros regardless of the time taken to carry it out.
In addition, the EDQM charges companies for its travel and accommodation expenses. Companies are also requested to pay the costs of and to organise transfers for the inspectors and any experts to and from the hotel and the site.
The EDQM sends an invoice. Full payment is due within 30 days of its date. Several payment options are possible: payment by credit card via the EDQM Online Store or by bank transfer.