Q3 2012 MRP finalized

This surely was a “long time, no see” quarter as two previous clients from ages ago, twenty years to be more precise, now returned to us and called in our support for a second time around. One of these regards a pharmaceutical wholesaler with its main activities in international medical (emergency) relief programs. Such programs have intensified their quality focus significantly over these twenty years, nowadays necessitating vendor qualification to be an essential part of the quality system of this distributor. One of our consultants will take care of this project and due to his earlier experience in a similar organization he will be ideally qualified for this job. And although much has changed in this company, it is still the same CEO at the helm, whom I met during our first visit.

Quite the opposite was the case with our second client from 20 years ago: a nuclear pharmacy in an academic hospital. In the past we implemented a GMP-program in relation to the compounding of radiopharmaceuticals and this time we will support this pharmacy in getting a license for the manufacturing of medicinal products for clinical investigations. All pharmacists involved in 1992 are gone and so are almost all the technicians responsible for the day-to-day operations. And I even wonder if investigational products together with medical-ethical boards were an issue in those early days. Now, we will establish new relationships with all new employees involved and we will upgrade the pharmacy-oriented GMP-system to a manufacturer-oriented GMP-system. We even might get lucky to stay on board as one of the Qualified Persons for this manufacturing site.

But in addition to these tales from the past we also reached a very significant new milestone in this quarter which is the finalization of a Mutual Recognition Procedure for a medicinal product under our custody on behalf of a USA pharmaceutical company. Refer to www.farmanet.nl for more details of this product. Now this has been finalized, we will soon start shipments of this medicinal product to the countries involved, in addition to shipments to the UK which we have been practicing for more than a year already. This is all a perfect demonstration of how we can support non-European companies with their entrance on the European market allowing them to focus on marketing issues while leaving all the regulatory obstacles for us to overcome.