An outstanding setup – Quality Control at Nordmark
At Nordmark, Quality Control unites all the necessary analytical activities to assure the quality of our active pharmaceutical ingredients, drug products and clinical trial preparations in compliance with the relevant regulations. To take account of the breadth of Nordmark’s services and the Company’s demands on quality, the Quality Control Department enjoys outstanding personnel and equipment resources.
More than 60 staff in six GMP laboratory units and work groups focus their expertise to service Nordmark’s production operations – continuously building an expertise from which long-term customers and cooperation partners can also benefit.
Work Groups and GMP Laboratory Units of Nordmark’s Quality Control
Analytical Services Laboratory Unit / Work Group
The Work Group is involved both upstream and downstream of the laboratory level. This is the Work Group, where for example specimens for the samples are organised. At the same time, the Work Group team is responsible for storage of the required reference samples and to ensure that specimens are sent to the laboratories together with the relevant research contracts from a Laboratory Information and Management System (LIMS) and processed there. The entire sample management work takes place in this Work Group.
Stability Testing Laboratory Unit / Work Group
The team is responsible for the entire stability testing management, i.e. for the planning, performance and documentation of the stability tests.
Starting Materials / Pharmaceutical Product Testing Laboratory Unit / Work Group
Services: The chemical and physical testing of starting materials and pharmaceutical products following Pharmacopoeia requirements.
Instrument Analysis Laboratory Unit / Work Group
Services: Testing of starting materials and pharmaceutical products with instrument analysis methods, for example, Thin Layer and High Performance Liquid Chromatography.
Natural Substance Analysis Laboratory Unit / Work Group
Services: Biological activity determination of active pharmaceutical ingredients and drug products with biological activity, for example, enzyme activity or blood coagulation inhibition activity.
Microbiology Laboratory Unit / Work Group
Services: Microbiological testing of starting materials, pharmaceutical products and samples for hygiene monitoring, for example, testing for bioburden.