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
This quarter we have welcomed a new consultant within our team: Elvira Graat, who joined us as of August 1. She has previous experience as a safety-data manager in a Clinical Research Organization (CRO). Subsequently she worked as a Safety Data Specialist in a major pharmaceutical company being responsible for
Radiopharmaceuticals not very often appear in these updates but this quarter they did as we performed a GMP-audit in a nuclear pharmacy to establish their compliance with the GMP-Z guidelines. GMP-Z is a typical Dutch “invention” and combines the regular EU-GMP rules with requirements for aseptic compounding in hospital pharmacies.
After receiving the marketing authorization in late 2010 we have this quarter started the importation of a medicinal product from the USA for which we act both as the EU marketing authorization holder and as EU import and release site. Actually it is not us, but our sister company Baggerman
This quarter we have extended our services to the Middle East welcoming a new distribution company in Lebanon which requires our support with the upgrade of their facility and quality system and to make these compatible with the European Good Distribution Practices (GDP) regulations. Such upgrading will include all the
Finally we have moved to our new offices in early July. It was about time we left our old premises as we stayed there from 1990 till 2010 without ever redecorating the interior. Simultaneously with this move we have said goodbye to twenty years of paper archives as only
tiffany describing the powerful impact of the movie Refill the refrigerant only when necessary. Once you have determined that it is necessary to refill the refrigerant in your car, purchase a can or two of refrigerant. Read the directions on the side of the can and then follow these to
This quarter definitely has been about manufacturing licenses and analgesics. By coincidence we started processing not less than 3 manufacturing license applications for logistic sites in the last months. Or maybe it was no coincidence after all, as many logistic service providers want to extend their service portfolio and their