3rd Quarterly Update 2009

Building projects dominate our list of new projects this quarter as two companies requested our support for the construction of their pharmaceutical production laboratories. One of these concerns a facility for the production of radiopharmaceutical parenterals, requiring the careful integration of GMP requirements and radiological safety requirements. The other facility is a compounding pharmacy where dermatological formulations will be developed and dispensed. For both facilities we will be involved in the design, construction and validation process. Subsequently we will act as Qualified Person (QP) for both facilities for an as yet undefined period. 

Letters from the Pharmaceutical Inspectorate startled some of our clients in this quarter. One of them was notified for an upcoming inspection visit in relation to the licenses which have not been updated for quite a few years. As a consequence experience with the inspection process is completely lacking in this company and therefore we were asked to assist in the preparation of the inspection visit. Another letter of the Inspectorate was more generally addressed to all marketing authorization holders requesting them information about their Pharmacovigilance processes and their designated Qualified Person for Pharmacovigilance (QPPV). Some smaller companies who do not have any resources available to implement or maintain a pharmacovigilance system called upon our support and outsourced their pharmacovigilance process to us.

The summertime traditionally is the season for interim QP-assignments and so it was this year again. Five pharmaceutical companies, three of which are Big Pharma companies, had us coming in these months to replace their Qualified Person going out for holidays. For some of those this is our yearly return and likewise it is not uncommon for us to have a more long lasting relationship with the company than the QP him/herself. Quite clearly such long duration is of benefit to our clients, at least someone should watch over the historical perspective of the quality processes implemented.