In 2006, Steinweg Medical GmbH, part of the NOWEDA group of companies, was the first blister center in Germany to be granted a manufacturing authorization for the production of patient-specific medicinal blisters in accordance with § 13 of the German Medicinal Products Act (AMG) and has been supporting numerous pharmacies ever since. Capacities are continuously being expanded and processes refined. The related machine blistering is considered the most modern and safest form.
gempex supports Steinweg Medical GmbH.
The blister centre is to be relocated to a new site in order to increase capacity. As production can only be carried out a few days in advance, the relocation of technical equipment and IT systems must be completed with maximum reliability within the narrow time frame.
Along a process-oriented concept focused on the essential GMP requirements, all trades were efficiently qualified. Protocol, testing and documentation flowed into each other in a well designed manner. Selective consulting on various GMP aspects complemented the tasks.
For IT validation, gempex's CSV concept was tailored, implemented and put into service on the basis of detailed elaborated experience reports. Due to the close interlocking of the individual systems, the interfaces were of utmost importance. In the course of the relocation, IT systems and their data were transferred in a controlled manner to the new qualified IT infrastructure consisting of physical and virtual elements.
Intensive preparation, adept planning and the well-organized data transfer ensured success.
The GMP-compliant production started troublefree and on time for the planned go-live. The authorities immediately issued the manufacturing authorization for the new site.
For questions on this topic, please contact Frank Studt, Managing Director of gempex, at contact@gempex.com.