Good Manufacturing Practice (GMP) Production Site
The production of radiopharmaceuticals for human application under a marketing license, manufacturing authorization or in a clinical trial must follow international GMP guidelines (as with pharmaceuticals in general). The purpose of GMP is to confirm identity, strength and purity and to ensure the uniform quality and safety of a pharmaceutical product. GMP, based on quality assurance of the system, encompasses everything that impacts the quality of the (radio-)pharmaceutical product (i.e., premises, personnel, equipment, raw materials, hygiene and monitoring, quality control and documentation). Our GMP-based facility for radiopharmaceutical production, put into operation in 2016, meets the highest standards of the current GMP requirements in order to satisfy modern demands for products that meet the highest standards for availability, reliability and patient safety.
Regulatory Aspects for Human Application
In Germany, radiopharmaceuticals can be produced and applied in the context of four legal frameworks which fall under either the ‘Medicinal Products Act’ (Arzneimittelgesetz, AMG) or ‘regulation on radioactive or ionizing radiation treated medicinal products’ (AMRadV)
• Marketing license (AMG §21 ff)
• Clinical trial (AMG §40 ff)
• Clinical use of a compound known in the literature (AMRadV §2 Abs. 1)
• Production and use for dedicated patients under direct responsibility of a nuclear medicine physician (AMG §13 Abs. 2b).
For the first three regulations, a manufacturing authorization from the local authority is mandatory, and GMP rules have to be followed. A marketing license is granted by the federal institution (BfArM) and allows for commercial distribution of a product.
Our products and what they are used for
Our radiopharmacy produces tracers and radiolabeled drugs not only for diagnostics (PET) but also for therapy, utilizing all four of the above mentioned possibilities. Products are used in-house for PET/CT and PET/MRI and are also offered to external customers outside Tübingen and to scientific collaboration partners. Under AMG §13 2b, external physicians may also produce a nonlicensed product for their patients in our laboratory with support from our staff.