Q4 2011 Positive GMP-audit

This quarter we witnessed an unusual number of inspectorate visits to pharmaceutical distribution companies for which we hold Responsible Person positions as required according to the Good Distribution Practices guidelines. Two of these companies distribute medicinal oxygen to health care facilities as well as to home care patients. Medicinal oxygen has only since a few years been registered as a medicinal product and its delivery directly to patients by distribution companies, not being pharmacies, is something which is not compatible with the Dutch Medicines Law as only pharmacies have this authority. Therefore, additional requirements have been established by our Ministry of Health to harmonize this typical situation with our laws. Contact us in case you are interested to learn more about this peculiar position of medicinal oxygen in our regulatory framework.

Two longlasting projects came to an end in this quarter one of which required our involvement in finding a new Regulatory Affairs Director for the regulatory department of a major OTC company. Although you would expect that ample candidates would be available for such a position, surprisingly it took us months to find these. This search involved some staffing companies who helped us in spotting suitable candidates, but only after quite a few “unfulfilled promises” there was a perfect match. Luckily for this company an experienced expat returned to the Netherlands from the North-American continent and appeared the ideal candidate for this job.

New pharmaceutical manufacturing companies are hard to find at present time but we guided such a company through the GMP-compliance landscape during more than one year. And eventually in this quarter it was audited by our pharmaceutical inspectorate with a positive outcome, meaning the assignment of the GMP-certification to be expected shortly. This will enable us to build the marketing authorization application for their new oncolytical product, an application which by nature needs to taken through the EU centralized procedure. So there’s not only “doom and gloom” for the pharmaceutical industry where so much is to be read about in your professional magazines, but there is still the occasional bright star enlightening new therapies for hitherto unmanageable diseases.