Inspection Readiness and Many Years of GDP Consultancy as Lead Consultant from gempex to United Pharma Partners

UPP United Pharma Partners is a medium-sized company specialized in (pre)wholesale of temperature-sensitive medicines for human use for rare and orphan diseases. UPP is a pan-European distribution specialist offering its various partners individually tailored solutions for the logistics of pharmaceuticals under GDP conditions. 

gempex has been supporting UPP, formerly Med-HS, in all important GDP issues since 2016. From consultancy for new GDP projects to direct presence and on-site support, the flexibly retrievable services range. Goal-oriented, efficient and good teamwork ensures a high level of trust.

The initial project of the long-term cooperation was the optimization of the Quality Management system, which was completed with the successful GDP certification. Since then, gempex has been the contact whenever GDP topics are touched upon. With a view to economic efficiency and compliance, individual solutions for sometimes very specific products are required.

In an initial gap analysis, the need for adaptation and optimization as well as possible solutions were identified. Based on a derived to-do-list, process-describing documents had to be revised and supplemented, and work instructions for the wholesale routine had to be created. In a subsequent inspection, the measures proved their worth and were further optimized selectively. 

This was followed by the development and implementation of regular GDP training courses for employees on topics such as regulations, the QM system, storage areas and transport, processes and documentation, claim management and the special features of international shipping. 

Another project was the qualification of the IT infrastructure.

UPP is safely positioned in the field of GDP and goes relaxed into the following inspections and customer audits with a strong consulting partner at its side.

For questions about Good Distribution Practice, optimization of quality management systems and Inspection Readiness GDP contact Tim Ohlrich, Manager GMP Compliance Projects, via