There are a lot of old pharmaceutical companies which have not adapted themselves to new GMP regulations or have been modified over many years without regulated change controls. In these cases there is a tendency to evaluate current situation in terms of compliance with latest GMP regulations.

PDI Co has a very good experience and knowledge to help clients who likes to have a real assessment of their current situation in their hands. Our subject expert engineers are able to provide architectural as built drawings and evaluate mechanical and electrical infra-structures.

At the next step current situation will be compared against one or several GMP guidelines such as PIC/S or EU-GMP and finally a GMP risk assessment will be done. We have a very good experience with this approach to convinced investors for renovation. Once the renovation process is approved by client, a preliminary conceptual design will be done and project phases and steps are defined together with cost estimation and a timetable. The output of this process is a road map for company renovations.

When there is a need for a third party to evaluate the current installations, which may have been modified over many years without regulated change controls Telstar can assist. For example if there are problems such as malfunction of equipment or GMP related deviations in pharmacopeia waters systems, process equipment, HVAC system, or even in the control systems. Our subject expert engineers will be able to assess all of these problems and propose improvements and long term solutions.