Due to our international and interdisciplinary work, we are often involved in advisory consulting, project and inspection activities simultanoulsy. Through this we are continuously engaged in the most recent GMP-regulations and their interpretation concerning process and cleaning validation in API manufacturing. This is also what keeps our expertise up-to-date and what allows us to provide Your company with a customized and risk-based solution to Your needs. We also gladly support You in the practical concept implementation.
- Definition and optimization of validation concepts (manufacturing processes and cleaning procedures), including Your validation master plan
- Preparation of master SOPs for process validation and cleaning validation
- Risk analysis in order to determine validation gaps and needs
- Strategy development for minimization of time and effort for cleaning validation, employing intelligent bracketing concepts
- Planning, organization and realization of process and cleaning validation
- Training of employees on all aspects of process validation and cleaning validation