Upkeep of the production license for pharmaceutical products in small quantities

The pharmaceutical laboratory of the pharmacy Dr. Kreyenbühl in Switzerland specialises in the production of small quantities of pharmaceutical products according to “GMP for pharmaceutical products”. After the pharmacy moved to its new location in Horn on Lake Constance, the new premises had to meet the GMP requirements.

With the help of the GMP experts from gempex, all quality-relevant facilities and processes were extensively checked in order to be able to make appropriate adjustments. The current status was analysed and suggestions for improvement were written down in a list of measures, which should contribute to the continuation of the GMP status. Master plans and various document templates were drawn up and employees in GMP training courses were made aware of the topic.

A GMP consultant from gempex temporarily took over the function of head of quality assurance in order to support the project´s smooth running. Therefore the cantonal pharmacist renewed the production license for pharmaceutical products in small quantities and also improved the understanding of GMP and GMP-relevant processes. This is an enormous advantage regarding the revised Therapeutic Products Act (Art. 30), which has been in force since January 01, 2020, because it is now mandatory that pharmacies must have an appropriate quality assurance system in terms of personnel, medication, services and infrastructure.

Further information on this topic and how gempex can support in the introduction of a quality management system according to ISO 9001 can be looked up at GMP and Pharmacies.

Project details to Topwell can be found on the gempex website references.