IMP labeling is considered to be a manufacturing activity according to Directive 2001/20/EC. Based on EU regulations the manufacturer of medicinal products needs to hold Manufacturing and Importation Authorization. The manufacturer’s QP is responsible for ensuring investigational products meet EU GMP.
From 1st Sept 2020, ClinPack Ltd. holds GMP Certificate – MIA number: HU-M-CLIN.
We provide the following QP services:
- QP batch certification: QP confirms that the operations performed on-site has been carried out following GMP, as well as all the procedures specified by the technical agreement.
- QP batch release: after the certification and depending on the scope, our QPs can cover the first step of the release as well. Within its framework, QP confirms that the batch of IMP has been manufactured in compliance with EU GMP, Investigational Medicinal Product Dossier (IMPD) or the Clinical Trial Authorisation (CTA), and the Product Specification File (PSF).
- QP consultation services, participation in meetings and regular conference calls, proactively informing clients about the latest information on EU regulatory updates.