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According to the revised chapters 3 and 5 of the GMP guideline, the strategy for preventing cross-contaminations in shared GMP facilities should be based on a toxicological assessment of the products manufactured. The toxicological evaluation including the calculation of Permitted Daily Exposure (PDE) limits should have been completed by December 2015 for medicinal products for human use that are produced in shared facilities.
Our toxicologists and GMP experts are cooperating very closely
We help you evaluate, whether your current cleaning concepts are still adequate in view of the determined Permitted Daily Exposure (PDE) values or whether further action is required.
Our GMP experts have great experience in developing and implementing