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Avrupa Komisyonu’ndan Kalifiye Kişiler Bildirisi – İyi Klinik Uygulamalar

Avrupa Komisyonu, İyi Medikal Uygulamalar çerçevesinde Kalifiye Kişiler Bildirisi taslak şablonunu hazırladı (İng)

 

QP Audits necessary for IMP Export in EU

The European Commission has published a draft template for the Qualified Person’s (QP) declaration concerning GMP compliance of investigational medicinal products (IMPs) manufactured in non-EU countries: http://ec.europa.eu/health/files/gmp/2013-02_cons.pdf
The template would be part of the dossier submitted with a request for authorisation of a clinical trial.

In this template, the QP should confirm that the IMP manufactured in a third country meets EU GMP standards for IMPs. This could be proved by either a personal on-site audit or an audit conducted by a third party or by another QP employed by the importer. If no audit has been performed, a brief justification and explanation should be provided, describing how the QP knows that standards at least equivalent to EU GMP are being followed at the site.

QPGMP Declaration indir…