3rd Quarterly Update 2008

Medicinal gases required our thorough attention this quarter. These products were relatively late recognized as medicinal products, similar to radiopharmaceuticals which likewise were unregulated products before 1992. Only in recent years the first marketing authorizations for medicinal gases  have been granted in NL, leading to the uncommon appearance of patient leaflets on oxygen cylinders to be delivered to hospitals, nursing homes and home care patients.

In hospitals this recognition has led to the formal involvement of hospital pharmacists in the supply and distribution of various gases to the operating theatres and wards. We audited one particular hospital to assess the compliance of this involvement with the GM/DP-regulations.
In addition, a leading supplier of medicinal gases in NL asked us to support their regulatory affairs department with respect to both national and European procedures.

With the manufacture of medicinal products slowly moving east towards India and China, we did not submit manufacturing license applications for new plants in the Netherlands very often during recent years. Yet, quite uncommonly, two of those were prepared in this quarter. One of which refers to a new manufacturing plant for radiopharmaceuticals. Such a plant requires the complex interfacing of GMP-regulations and radioprotection guidelines, a challenge not uncommon to us as we have participated in similar projects in the past. The other license regards a packaging facility for secondary packaging of medicinal products including biotech and cold chain products.

Even more manufacturing of medicinal products was at stake this quarter, but not on an industrial level but on a pharmacy level. With the preparation and/or compounding of individual prescriptions gradually disappearing from Dutch pharmacies, due to quality constraints, new entrants appear on the pharmaceutical market which exclusively focus on such compounding and dispensing. These compounding pharmacies, however, will have to comply with specific regulations (GMP-z) which strongly resemble the industrial GMP-regulations but which take into account the very small scale of this manufacturing process. We will support such a new pharmacy with the design and construction of its premises as well as with the implementation of these GMP-z requirements.