Who we are....

The Heidelberg University Hospital's manufacturing facility is a pharmaceutical company that specialises in the research, development and manufacture of human medicinal products for clinical trials. Our close links to the day-to-day running of the hospital give us the opportunity to adapt even more quickly to the individual needs of doctors.
All our services are focussed on the benefits for our customers, especially the patients. Thanks to our experience in patient-specific drug production, we can react quickly and flexibly to changes and requirements, e.g. in the case of applications to the authorities. Our aim is to support investigators in conducting clinical trials by providing high-quality clinical trial samples.

Pharmaceutical companies that operate within the scope of German legislation and manufacture and distribute medicinal products are obliged to comply with and implement the German Medicinal Products and Active Substance Manufacturers Ordinance (AMWHV) and thus the guidelines of Good Manufacturing Practice = GMP. We can draw on ten years of ISO certification in the development, manufacture and distribution of medicinal products and the provision of pharmaceutical services.

We ensure that

• medicines are designed and developed under GMP (Good Manufacturing Practice), GCP (Good Clinical Practice) and GLP (Good Laboratory Practice)
• agreements are made for the manufacture, supply and use of the correct starting materials and packaging materials
• necessary tests and validations are carried out
• medicinal products are properly manufactured and tested
• medicinal products are stored, distributed and subsequently handled in such a way that quality is maintained throughout their shelf life
• self-inspection and quality review procedures are in place to assess the effectiveness and suitability of the quality assurance system

The University Hospital's manufacturing facility fulfils the requirements that apply to all pharmaceutical companies and thus ensures that high-quality medicinal products are produced. Personnel with sufficient professional qualifications are required by law. Chief Pharmacist Dr T. Hoppe-Tichy and Mr Dominic Störzinger are qualified as Qualified Persons in accordance with the AMG. Production and analysis must be strictly separated and are the responsibility of the Head of Production and the Head of Quality Control respectively.

The type, size, number, location and equipment of the operating rooms must guarantee the flawless manufacture, testing, storage, packaging and placing on the market of the medicinal products. An adequate standard of hygiene and controlled temperature and humidity conditions in these rooms are decisive for the quality of the medicinal products manufactured. The manufacturing company uses appropriate controls to prove that this high standard is maintained at all times.

The primary task of the quality management system is to ensure the quality of the products during production and quality control, but also to take precautions in advance and introduce appropriate measures to ensure that problems do not occur or cannot occur again. Examples include the qualification of devices and equipment as well as the validation of processes.