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 Department 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.
The inspections are carried out by teams composed of official inspectors from the competent authorities in the EU/EEA (or in countries which have a Mutual Recognition Agreement with EU in GMP sector) and EDQM inspectors having the same qualification. Typically, they last 3 days. 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.
** EMA/572454/2014, current version - Compilation of Community Procedures on Inspections and Exchange of Information.
Compliance: when the conclusion of an inspection is favourable, EDQM provides 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. GMP certificates can be found on the EudraGMDP database;
Non-Compliance: in the case of major/critical deficiencies noticed during an inspection, or in case of a refusal to be inspected, actions may be taken on the corresponding CEPs or applications for CEPs (suspension, closure, withdrawal). Additionally, information of non-compliance is issued in the EudraGMDP database by the inspector from the competent authority of EU/EEA member state. Suspensions and cancellations of CEPs are reported on the EDQM's website and circulated to all concerned authorities, including international authorities with which bilateral confidentiality agreements have been established, so that the necessary actions regarding related marketing authorisation(s) can be taken. Holders are also obliged to inform their customers.
This approach is also applicable in case of non-compliance for an inspection carried out by an EU/EEA inspectorate.
A 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
EDQM inspections are subject to payment of fee, which 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.
In addition, the EDQM charges companies for travel and accommodation expenses.
International collaboration and optimisation of inspection resources
The EDQM is committed to optimise the inspection resources as much as possible. For this reason it has been a member the International API Inspection Programme since 2008. More information on this programme is available here.