When compared to the typical chemical-physical API synthesis, the manufacturing of biological APIs requires highly specialized processes, including the use of live organisms.
This is why the legislative bodies have laid out special requirements for the production of biological APIs and drug products. Yet the regulations often fall behind the actual realities in this rapidly growing market. This is why guidelines in force need to be carefully interpreted and gaps have to be filled with risk-based concept approaches.
We are well acquainted with these requirements and are happy to support You regarding the following tasks and questions:
- Risk analyses for identification and definition of qualification, calibration and cleaning validation to be done
- Planning, conceptioning and realization of cleaning validation
- Qualification and calibration of biotechnological installations and facilities
- Conceptioning of clean rooms and containment areas (zoning concepts, differential pressure concepts)
- Design and review of personnel and material flows (including lock concepts)
- Set-up of monitoring systems
- Optimization of quality assurance systems