When submitting a trial application for a clinical trial in the EU/EEA using an Investigational Medicinal Product (IMP) manufactured in a 3rd country (a country not a member of the EU or EEA), a Qualified Person’s (QP) Declaration is required.
This declaration is intended to guarantee that the IMP has been manufactured to standards at least equivalent to EU-GMP.
The European Medicines Agency (EMA) has provided a standard template for the declaration covering the following points:
- The EUCT number. This number identifies a specific clinical trial.
- The name of the IMP(s) covered by the declaration.
- The Manufacturing and/or Importation Authorisation (MIA) number under which the declaration is made.
- The name and address of the manufacturing site(s) and the activity(-ies) performed at these sites. Site to be included in the QPD include but are not limited to sites performing packaging, labelling, storage, testing and release.
- A statement that the person making the declaration is a QP.
- A statement that the IMP has been manufactured in compliance with GMP at least equivalent to EU GMP.
- A list of the manufacturing sites previously mentioned and the basis of the QP’s verification of their compliance with GMP.
- The preferred method of verification is an audit of the quality system of the 3rd country site – the auditing party and date of completion of the last audit must be recorded.
- If an audit has not been performed, a brief justification must be provided, explaining how the QP knows that standards at least equivalent to EU GMP have been adhered to.
- Finally, the QP must sign and date the declaration.
Audits should have been completed within the previous three years. The QP should either perform an on-site audit in person or review the report of an audit conducted by a third party. In the case of a third-party audit, a detailed review of the audit report, including a review of the auditor’s CV, should be conducted. The QP must satisfy themselves that the audit has established compliance with EU-GMP, and that the auditor is suitably qualified/experienced.
The expectation of the regulatory agencies is that an in-person audit be conducted. Therefore, if an audit report is not available, a sound and robust justification must be provided.
If you have an upcoming audit or would like to support our oversight and qualification of your suppliers, we have a European wide panel to support your project. Please contact us at email@example.com for more information.
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