Regulatory requirements for Robotic applications in Aseptic Manufacturing.

Since the first publication of the EU GMP Annex 1, the topic of automation with robotics has increased significantly. Employees and their possible contamination when working on or close to the sterile product are seen as a major risk in Annex 1. The chapter Principles mentions the use of robotics as a measure. However, in order to implement the filling of sterile liquid pharmaceutical products fully automated and with robotics, a lot of knowledge in the areas of design and GMP is required to implement this. It is also necessary to develop new methods and technologies to automate manual processes. Especially when introducing the filling path or how the stoppers are transported without a sorting bowl. How should automatic viable monitoring work and what measures are necessary to work with highly active substances. The presentation explains all the important points and also points out possible mistakes that can be made. The presentation is also supplemented by the global regulatory authorities training on the topic of robotics and their feedback the presenter did in 2023/2024