When an inspection outcome is positive, a GMP certificate is granted by the inspector from the competent authority of the
EU or EEA to the manufacturer. Additionally, EDQM issues an attestation stating that the company has been inspected and found
compliant with GMP and the CEP application dossier.
In the case of major deficiencies or in case of a refusal by the company to be inspected, actions may be taken on the corresponding
CEPs or CEP applications (e.g., suspension or cancellation of the CEP, closure of ongoing CEP applications). The inspector
issues a statement of noncompliance which is also distributed to the appropriate competent authorities. Suspensions and cancellations
of CEPs are reported to all concerned authorities so that action regarding related marketing authorization(s) can be taken.
Suspensions and cancellations are published on EDQM's website. A suspension may only be lifted after the company takes satisfactory
corrective actions and after a re-inspection confirms the implementation of those actions.
EDQM is involved in the international pilot project coordinated by the European Medicines Agency to exchange information on
API inspections with the US Food and Drug Administration and Australia's Therapeutic Goods Administration (TGA). EDQM has
also carried out joint inspections with the World Health Organization (WHO) for API manufacturers covered by CEPs which were
also within the scope of the WHO prequalification program. The WHO prequalification of medicines is a service provided by
WHO to assess the quality, safety, and efficacy of medicinal products to give international procurement agencies the choice
of a wide range of quality medicines for bulk purchase for distribution in resource-limited countries.
Susanne Keitel, PhD, is director of the European Directorate for the Quality of Medicines and Healthcare (EDQM) of the Council of Europe in Strasbourg,
France. EDQM is also responsible for the European Pharmacopoeia (Ph.Eur.), Susanne.Keitel@edqm.eu