cGMP describes guidelines for “good manufacturing practice”. The focus here is on the quality assurance of the production processes and production environment for the processing of pharmaceuticals, active agents and medical devices.
Quality management system (QM system)
We employ a QM system that includes the “good manufacturing practice” in accordance with our activities. All in-house divisions concerned with the creation, maintenance and implementation of the QM system are permanently subject to the requirements of the EU GMP guideline.
The Qualified Person checks the batch release and thus the formal and substantive accuracy of the batch documentation in accordance with the EU GMP guideline.