Groningen, February 6th, 2018: InnoCore Pharmaceuticals renewed the GMP certificate including laboratory authorization converted to manufacturer’s authorization
Compliance to (international) high quality standards is one of the key elements of the InnoCore approach. Our quality system is based on ICH Q7/EU Eudralex volume 4 GMP. It assures the appropriate level of quality for all drug development project phases and fulfills the (inter-)national requirements where applicable. This is not only recognized by our customers during their audits, but also by the Dutch competent authority.
The first GMP inspection of InnoCore was in 2013 based on our laboratory authorization. This successful inspection resulted in the issuance of our first GMP certificate.
As a consequence of changes in the Dutch license system, we have converted our national laboratory authorization into a European manufacturer’s authorization for chemical/physical quality control testing of human investigational medicinal products. Based on this change, the Dutch Health and Youth Care Inspectorate inspected InnoCore again on the 6th of February 2018.
There were no critical or major deficiencies and a new GMP certificate was issued, confirming that InnoCore complies with the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC. Our manufacturer’s authorization is granted based on this successful inspection. Both our GMP certificate (number NL/H 18/2003921) and manufacturer’s authorization (authorization number 7035 F) are available in EudraGMDP.
The successful audit and granting the manufacturer’s authorization are an acknowledgement of our continuous attention to quality.
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