Why Center of excellence?
OctoPlus is globally acknowledged as a Center of Excellence for formulation & process development of complex injectables
What makes OctoPlus a Center of Excellence is the full implementation of the Operational Excellence Program (OEP) which guarantees a high level of quality and an increased operational efficiency and agility. The operational excellence team consists of certified Six Sigma Black Belts. Consequently, risks and costs are significantly reduced and the regulatory compliance is ensured.
Operational Excellence program
The focus of our OEP program is on People, Process and Technology.
Our employees are trained with Lean Six Sigma methodology
We fully implemented the Quality by Design methodology (QbD) so ensuring the development of high quality and efficient processes. QbD is strongly advised by regulatory agencies EMA, FDA and ICH.
We use advanced statistical tools like Design of Experiment (DoE), Robustness by Design and our own OctoDesign are used to develop cost-effective, scalable and robust processes and analytical methods.