Medicom Pharma GmbH has been offering products for healthy living since more than 25 years, focusing on premium vital substance combinations. The company distributes its product portfolio across Europe, primarily in the direct business and through the Medicom online shop. Dosage forms range from soft gel capsules to direct granulates and tablets to tinctures. As a pharmaceutical entrepreneur and wholesaler, Medicom is also subject to supervision by the competent authority.
gempex supports Medicom Pharma GmbH with all GDP matters over the years. The initial project was to revise the quality management system, including assistance in communication with the competent authorities. After this was successfully concluded, gempex provided support with all good distribution practice matters over the years in the daily GDP business and as the lead consultant. Further projects such as the warehouse relocation and establishing a new site were successfully implemented. The full range of GDP services offered by gempex was utilised – from consultancy to realization.
The existing QM system had to be fundamentally upgraded and inspection readiness needed to be achieved. The QM system was integrated into routine operations on an ongoing basis, improved in terms of efficiency and tailored to the customer. Communication with the competent authorities was another support focus, for instance during the approval of another operating establishment and the relocation of the external warehouse. Thanks to good preparation and verification through self-inspections, official inspections were successfully passed multiple times at all sites. The accompanying consultancy and support in the day-to-day business were complemented by regular employee training. A stable QM system with clear, efficient processes was realized.
Initial, intensive support for the customer transitioned to ongoing assistance covering all GDP matters. All current QM issues were addressed in regular team meetings and solutions were defined and implemented. For instance, documentation was amended, self-inspections were carried out and the load on QM functions in the daily business was reduced.
Over time, gempex advised and assisted Medicom with all GDP-related matters and provided targeted support for the development of the internal processes. Now the customer is positioned to complete all QM tasks themselves.
For questions about Good Distribution Practice, wholesale of pharmaceuticals and transport validation contact Tim Ohlrich, Manager GMP Compliance Projects, at email@example.com .