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Homepage / Certification of Pharmaceutical Substances / Inspections

The Inspections Programme

The EDQM continues its inspections and reinforces its communication and information campaigns in China

The European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe) has recently carried out an inspection campaign of production sites for active substances for pharmaceutical use in China, with the assistance of official European inspectors. More information...

The EDQM inspection program: who carries out inspections?

Recent articles covering issues related to the quality of active pharmaceutical ingredients and medicines published in the media falsely make reference to so-called "EDQM auditors". We therefore wish to clarify who is involved in EDQM inspections.

The inspections run in the context of the EDQM inspection program are normally carried out as team inspections by official inspectors from the competent supervisory authorities of Member States of the European Union (EU)/European Economic Area (EEA), from countries which have a Mutual Recognition Agreement (MRA) with the EU in the GMP sector, or in some cases from WHO, and EDQM-Inspectors. For inspections carried out in non-EEA member states, local inspectors are also invited to participate.

In some countries (e.g. China), EDQM may use interpreters to accompany the team of inspectors in order to ensure accurate communication between company staff and the inspectors. The EDQM does not appoint auditors to carry out inspections. Therefore neither interpreters nor auditors can claim to be EDQM auditors.

Suspension or cancellation of a Certificate of Suitability

The EDQM explains its policy on the suspension or withdrawal of a certification of suitability.  A document describing the scope, the decision making process as well as the resulting actions is now available. More information...

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 - Compilation 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 & Financial Provisions

As of 1st April 2009, the EDQM will charge companies the travel and accommodation expenses of its inspectors and of any experts involved in the inspection, in addition to the inspection fee. The inspection fees will remain unchanged, i.e. an inspection fee of 5 000 Euros is charged for each inspection of an individual site initiated by EDQM, and 9 000 Euros for each inspection of an individual site requested by a company. These fees are independent of the nature of the product, the length of time taken to carry out the inspection and the type of manufacturing operation being inspected.

The EDQM will send an invoice to the company. Full payment is due within 30 days of the date of the invoice. Several payment options are possible: by credit card online via the EDQM Store, by bank transfer and cheque.