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Pharmaceutical Quality Assurance Group
The most important task of our group is the supervision of the quality management system in connection with the GMP conform radiopharmaceutical manufacturing activity running in our institute. This role not only involves the release of incoming materials and finished products, but also requires the maintenance of an up-to-date documentation system about manufacture, out of specification and deviations, change control and pharmacovigilance.
Furthermore, the Pharmaceutical Quality Assurance Group is responsible for any changes in any existing Marketing Authorisations and for the organisation of the registration procedure of novel radiopharmaceutical agents. Also, the head of the group is the contact person towards the National Institute for Quality- and Organisational Development in Healthcare and Medicines – National Institute of Pharmacy.