For many enterprises in the Life Sciences sector, the validation of their processes for quality assurance becomes increasingly pivotal. Qualification according to the guideline "Good Manufacturing Practice" (GMP) is being more and more enforced Europe-wide.
For the elaborate GMP qualification process to be successful, DERU has been offering consulting service in this sector for many years now. DERU specialists analyse internal processes on an individual basis, they identify potential risks and restructure the procedures with the client if necessary. A validation master plan represents the guideline for the qualification since it structures the entire qualification programme. According to individual demands, audits for technical systems or the compilation of GMP relevant standard work instructions may be included.
The GMP qualification may parallel a new construction or conversion project as well. The required validation and qualification plans, specifications or check lists are then compiled during the planning phase and construction supervision. The compliance with the GMP requirements is monitored until the project's completion; it is documented and double checked within the scope of the initial commissioning. The final qualification report forms a trustworthy basis for any possible QM audits.