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GMP operations

Even during development it is mandatory to produce Active Pharmaceutical Ingredients (APIs) under defined, controlled and documented conditions applying the requirements laid down in the respective law, international regulations or GMP guidelines. Pharmedartis provides for GMP operations services, from GMP consulting through the manufacture including all quality related activities.

GMP Consulting

As early as possible GMP consulting should constitute the foundation of the project management plan, which provides for the timely supply of clinical trial material right to the customer‘s need. Pharmedartis offers GMP consulting services from the preclinical phase through the “routine“  manufacture of Active Pharmaceutical Ingredients (APIs).

Manufacture

Efficient GMP production of biotechnological APIs requires a highly specific knowledge base and infrastructure, difficult to establish at small biotech and even mid-sized fully integrated pharma-ceutical companies. Pharmedartis as spin-off of the Fraunhofer Gesellschaft has the exclusive marketing rights for its - by the Governmental Control Agency certified - 600 sqm state-of-the-art GMP facility in Aachen, Germany, and serves as a contract manufacturer of API.

Quality System, Quality Operations, and Qualified Person

To reliably achieve the quality objectives and the required API quality, Pharmedartis commits to run an adequately designed and implemented Quality (Assurance) System.

Daily work Quality Operations, i.e. Quality Assurance and Quality Controls, of the API utilizing standard analytical tests as well as more sophisticated methods, are performed.

Our Qualified Person takes over the responsibility for the decision about the acceptability of the APIs and assumes the duty for the batch release according to the relevant regulations.