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NP-014 Development of new production when neither packaging nor some of the raw materials conform to european standards
  1. K Bødker Rubach-Larsen,
  2. A Rungø,
  3. A Eskildsen,
  4. L Skovhauge


What was done?A new MR-scanning technology, hyperpolarisation, for the quantification of metabolic processes with an extremely high sensitivity enables physicians early detection of treatment effects in e.g. cancer and diabetes. A so-called Pharmacy Kit is used in the hyperpolarisation process and consists of a specially designed packaging with tubes, vessels and filters containing the contrast agent and buffer solutions. The objective for the hospital pharmacy 1 was to manufacture Pharmacy Kits complying with Good Manufacturing Practice (GMP), though neither packaging nor two of the raw materials conformed to European standards.

Why was it done?A research team at the MR Centre (MRC 2 wished to set up a production of Pharmacy Kits, but had no prior experience with, or licence to, manufacture drugs). Thus, the hospital pharmacy was asked to participate in the development of such a production.

How was it done?The MRC research team presented the hospital pharmacy with the desired combination of compounds and the packaging required for Pharmacy Kit production. The task for the hospital pharmacy was then to set up a manufacturing process that met these requirements and complied with the guidelines for GMP. A production complying with GMP was developed in close collaboration with the MRC and an ongoing contact with the Danish Medicines Agency. During the process the hospital pharmacy executed its own microbiology test in order to determine if, and for how long, the non-CE-marked packaging could store the contrast agent and buffer solutions. Risk assessment of the raw materials not found in the European Pharmacopeia were conducted. The method investigated by the MRC already takes place in a few other places in and outside Europe. Experiences from these production sites were implemented and expanded with process optimisation and a specially designed equipment for the production.

What has been achieved?Due to a strong inter-professional collaboration between the MRC and the hospital pharmacy and due to qualified risk assessments, it was possible to set up a production of Pharmacy Kits according to GMP.

What next?When researchers contact hospital pharmacies with new ideas, we have to be willing to work with GMP in a different way by applying knowhow and risk assessments in order to ensure developments within the healthcare system.

References and/or acknowledgements Hospital Pharmacy Central Region, Production, Aarhus, Denmark.

MR Centre, Aarhus University Hospital, 8200 Aarhus N, Denmark.

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