1st Quarterly update 2007
“Risks first” is the title of the 2007 Work Program of the Dutch Pharmaceutical Inspectorate which reflects the new approach to give priority to those developments and products with the highest risk impact for society. Four priority areas have been identified with related activities to be performed in 2007. Quite surprisingly, one of these priorities refers to the large-scale production of pharmaceuticals in hospital pharmacies although the risk impact of this production by no means has been substantiated by the Inspectorate. Nevertheless, this will have significant impact for our agency as 30 hospital pharmacies are to be audited this year. I wonder how many of those will subsequently call in our support for the implementation or upgrading of their Good Manufacturing Practices. Already two of them did last month and no doubt more will follow in the course of this year.
We will meet the Inspectorate quite a number of times this year anyhow, as an uncommon number of requests did come in for support with wholesale or import license application’s for SME’s. Some of those extend their portfolio from medical devices only to include pharmaceuticals as well, while others are new affiliates of foreign pharmaceutical companies. Others did find rich sources of generics in India wishing to distribute those in the Netherlands or the Benelux and one of our clients is considering to open a European Distribution Center for pharmaceuticals coming from the Far East and from the USA. There is not much risk analysis involved in those projects as these all deal with EU-registered medicinal products. We only need to “prioritise” our Qualified Person (QP) -capacity to these projects as we must exclude one QP operating for two competing pharmaceutical companies.
Winter time apparently is not a good season for Dutch affiliates of Big Pharma as these seem to run out of staff during these months. Just like the early months of 2006 we now had to assign three consultants to the RA-department of another Top-10 pharmaceutical company to fill in the gaps. Although serious attempts are being made by this company to recruit new personnel, we expect that we will stay on board for another couple of months. So hopefully after that we may get new inspiration from Gershwin, singing “It’s summertime, and the living is easy”.
