Commissioning and Qualification
Progress-PME has already actively helped many companies to develop and implement new (bio) pharmaceutical processes. We are well acquainted with upscaling from lab scale to production facility, implementation of new production processes and optimisation of existing processes. We have also earned our stripes in the related qualification projects, for example qualification of installations, (QC) equipment, cleaning processes, computer systems and, of course, the actual production processes. We use a risk-based approach according to ICH Q8 and Q9 for the qualification.
Can Progress-PME help you?
To determine the critical processes, installations or functionality in your organisation, we conduct a risk analysis using various risk analysis methods based on ICH Q8 and Q9. We then use the results to assess critical processes, installations or functions in closer detail. The final results of the risk analyses help us set up the right development, implementation and qualification strategy. Before doing so, we map all the possibilities and impossibilities and risks, resulting in better planning and budgeting.
Our staff are experts in this method and guide your projects through the various phases according to schedule and budget. They do this from the following roles:
- Project Manager
- Process Engineer
- Construction Manager
- Qualification Engineer
During the whole project, Progress-PME obviously uses the applicable guidelines and advisory documents, including ISPE, GMP, FDA and GAMP.