The Programme

The EDQM inspection programme is an integral part of the Certification procedure and is elaborated in the context of the mandate given to the EDQM by the European Commission in application of Directive 2001/83/EC and Regulation (EU) 2019/6 as amended.

It aims 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.

As part of the CEP application, the manufacturers involved in the manufacture of active substances (API) and their intermediates are requested to declare that they manufacture according to EU GMP Part II and also their willingness to be inspected. Based on these declarations and a risk-based approach, the EDQM may or may not inspect the sites, and if they do, the inspection takes place either before or after the CEP is granted.

Every year, a programme of inspections is elaborated based on risk assessment and in accordance with EU recommendations**. This programme is adopted by the CEP Steering Committee.

The EDQM Certification Department is responsible for the establishment of the annual programme, the organisation and performance of the inspections and their follow-up, including the implementation of any subsequent actions regarding the related CEPs and communication with the authorities concerned.

The EDQM inspections are normally carried out by teams composed of an official inspector from the EU/EEA competent authorities (or from countries having a Mutual Recognition Agreement (MRA) with the EU in the sector of GMP for APIs) and an inspector from EDQM. They typically last 3 days. About 40 inspections are performed every year, including re-inspections.

For inspections carried out in non-EU/EEA/MRA member states, local official inspectors are invited as observers. Interpreters may be hired by the EDQM 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.

* 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.

Inspection Outcomes

Compliance: when the conclusion of an inspection is favourable, the EDQM provides an attestation stating that the company has been inspected and found to be in compliance with GMP and with the information submitted in the CEP application. The issuance of an EU GMP certificate is the responsibility of the competent authority of the EU/EEA member state having taken part in the inspection. GMP certificates can be found in the EudraGMDP database.

Non-Compliance: in cases where critical/major deficiencies are identified during an inspection, or in the case of a refusal to be inspected, actions may be taken on the corresponding CEPs or CEP applications (suspension, closure, withdrawal, removal of the non-compliant site if other manufacturers are involved at the same step). Issuance of a statement of GMP non-compliance is the responsibility of the participating competent authority of the EU/EEA member state. These are available in the EudraGMDP database. Suspensions and withdrawals of CEPs are reported on the EDQM's website (CEP database and Certification web pages) and circulated to international partners so that the necessary actions regarding related marketing authorisation(s) can be taken. CEP holders are also obliged to inform their customers and provide them with any information that will allow them to make an appropriate risk assessment and take any necessary actions. 

The EDQM may also take actions on CEPs or CEP applications (suspension, closure, withdrawal) in cases where a statement of GMP non-compliance is issued in the EudraGMDP database, without the EDQM having been involved in the inspection, where the manufacturer concerned holds CEP(s).

A CEP suspension will only be lifted when the company has taken satisfactory corrective actions and the implementation of the corrective actions has been confirmed by a re-inspection, either by the EDQM or by an EU/EEA inspectorate.

In the case of withdrawal of a CEP as a result of GMP non-compliance, if the applicant applies for a new CEP, the issuance of the CEP is subject to confirmation of the GMP compliance of the manufacturing site, e.g. via a re-inspection.

It should be noted that if a company refuses to be inspected after being notified by the EDQM, the CEPs in which it is involved will be withdrawn (or the site will be removed from the list of approved manufacturers).

Fees & Financial Provisions

EDQM inspections are subject to the payment of fees and travel expenses, which are indicated in the document "Fees and Inspection costs".

International collaboration and optimisation of inspection resources

The EDQM is committed to strengthening its collaborations and optimising inspection resources as much as possible. In particular it is involved in the following activities on an international level:

• Member of the International API Inspection Programme since 2008; more information on this programme and reports are available here.
• Associate partner of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), in particular, the committee of officials, the API expert circle coordinating committee and various working groups; more information on PIC/S can be found here.