The end of this quarter marks our 25th anniversary as the company was founded April 1 1987. A lot of water has gone under the bridge since then but not all has been forgotten and some highlights of that period deserve attention at this memorable moment in time. During the first couple of years I kept on my own but eventually I had to decide whether to stay alone or to give it a try and to build up a team of consultants to face the increasing and increasingly complex workload. Thanks to this decision in 1990 our team is now serving over 80 clients from various countries and continents with all kinds of drug regulatory issues.

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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.
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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 processing and entering adverse event information into the safety database and guaranteeing high levels of data quality and integrity. We look forward to her contribution to the pharmacovigiliance section of our team in the years to come .

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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. Z stands for Ziekenhuis meaning hospital. Such aseptic compounding in hospital includes the preparation of oncolytics, total parenteral nutrition solutions as well as radiopharmaceutical preparations. Radiopharmaceutical preparations usually include labeling procedures for small molecules, peptides or cells and are being used on nuclear medicine departments in hospitals. Interestingly, in the early eighties of the last century nuclear medicine was expected to become extinct for environmental reasons but went through a remarkably recovery due to the introduction of various short-lived new isotopes for positron emission technology like 18F, or various rare metals for labeling of proteins like 177Lu.

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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 FarmaNet who is the legal entity holding these responsibilities. This structure enables us to service non-EU pharmaceutical companies and to provide these with EU market access for their medicinal products. Currently we have a second non-EU client from Asia who is interested in this possibility and may join us in the future. Just have a look at www.farmanet.nl if you want more info on this subject.

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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 classical GDP-issues like facility lay-out and product routing, appropriate Standard Operating Procedures to cover all the essential processes, training and qualification of employees and last but not least; temperature control of the warehouse. It is planned to finalize this project in the first quarter of 2011 enabling one of the major suppliers to audit the upgraded facility shortly afterwards.

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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 since a couple of years the regulatory documentation became digital in nature. So, hundreds of binders from long forgotten clients were collected by some professional archive destruction company leaving no trace of those confidential data. Let’s hope none of these clients ever turns up requesting us to return those files…….

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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 clients increasingly have a need for minor packaging activities to be performed at logistic sites. Minor as they are, they still fit the definition of  “pharmaceutical manufacturing” and therefore a manufacturing license is needed together with an EU Qualified Person to take full pharmaceutical responsibility of the manufacturing operations. Particularly with an increased flow of generics coming from India to the EU, the possibility of a “country-specific” secondary packaging process is a valuable asset for any logistic service provider.

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