This quarter we welcomed our new colleague Jasper Vink who brings with him broad experience with the manufacturing and quality control of radiopharmaceuticals including many years of Qualified Person responsibilities. This experience was obtained within a global manufacturing company and included various multi-site QA harmonization projects. Jasper will add extensive QP-capabilities to our team which has become necessary to accommodate the increasing demands from our customers to provide them with Qualified Persons responsible for the (EU-)market release of (radio)pharmaceutical products as well as to provide for radiosafety support to logistic processes covering such products.
But it is not only QP-capabilities which we need within our team, as QP-responsibilities usually also include obligations to audit third party contractors involved in the manufacture or quality control of medicinal products. In recent months we have performed a record number of such audits including a packaging facility, a logistics service provider as well as three separate quality control laboratories. These laboratories included a microbiological laboratory in NL, a contract laboratory for ethylene oxide sterilization residue testing in the UK as well as a pharmaceutical laboratory for final product testing in NL. And there is even more to come in Q2, as we then also need to audit another sterility testing laboratory in the UK, a dispensing set manufacturer in Italy as well as a contract manufacturer for empty sterile glass vials in Italy.
On the regulatory affairs frontier we have got the green light for two significant international projects including projects from Asia and South Africa. The first one will include two generic projects to be marketed within the EU and which will need a Decentralized Procedure to obtain a marketing authorization, not to mention the set-up of the EU importation and retesting processes. The second project is about a radiopharmaceutical 68Ge/68Ga – generator which will be processed through a centralized procedure. For this latter project we will have to start from scratch, building the eCTD gradually over the coming months, while at the same time eliminating all the administrative hurdles related to a centralized procedure such as SME-status, product eligibility, PIP waiver and introductory meetings. However we have been through this process before and we expect to successfully reach the finish again in the near future.