Q4 2013 Qualified Person & e-Leaflets

This quarter we welcomed our new colleague Susil Chotoe who brings with him broad pharmaceutical manufacturing experience gained in subsequently biotech, solid oral dosage forms and packaging facilities. Susil will add extensive QP-capabilities to our team which was necessary to accommodate the increasing demands from our customers to provide them with a Qualified Person responsible for the (EU-)market release of pharmaceutical products. However, just weeks before Susil came on board a large project came in from a Top-10 pharmaceutical company aiming at the introduction of an e-leaflet with it pharmaceuticals. So the newly acquired redundancy in our team almost immediately evaporated into thin air as we had to assign Susil to this project for a significant part of his time. Quite an interesting project though with regulatory, logistics an IT-challenges to be solved.

Worldwide supply chains keep on requiring our attention as this quarter we welcomed a new client from the Middle-East who procures his pharmaceuticals within the EU and then ships these to his home country. However, as the invoicing for these shipments together with the storage of part of the shipments is done by a Dutch subsidiary, this subsidiary was spotted by the Dutch Inspectorate as not being compliant to the Dutch pharmaceutical legislation. We then came on board to provide for the required wholesale license and the related quality system based on the EU Good Distribution Practices. Up to this point this project is not different from many other wholesale operations we have supported, but much to our surprise it appeared that also opiods were included in the shipments and opiods are quite a different subject when it comes to licenses.

Our pharmacovigilance-team did an excellent job with the support of a Dutch subsidiary of a global company who had great difficulties with their vigilance processes. An initial audit in April 2013 revealed numerous non-compliances which we were asked to remediate subsequently. The repeat audit in last October then was successfully concluded and we quote from the audit report: Following the audit conducted by me in April 2013, the company has made significant improvements in their PV system to make it more compliant with legislative requirements. Maintaining this progress will depend on developing a collaborative relationship with Baggerman who will need to be fully integrated within the company as the local pharmacovigilance unit.
You will not be surprised that we gladly entered into such a collaborative relationship…….