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.

QP declaration template

Download the latest version of QP declaration template provided by European Medicines Agency (EMA).

qp declaration template preview

 

 

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.

Read more about our service: EU QP DECLARATIONS or contact us for more information.

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