PQRI Workshop

Last week our partner Ulrich Köllisch participated in the FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing. In this interactive event regulators and industry shared their thoughts on implementing AI/ML solutions in the GMP environment.

Here are the top 7 take home points from Ulrich:

1. Definitions/glossary are a mess in the GMP-public. Here a need for clarification was clearly identified.
2. The compliant use of dynamic models is not yet set, most solutions presented at the workshop lock the model and train it in defined intervals.
3. Interpretability is key: ML solutions need to be documented/presented/validated in a way that enables quality units and inspectors to understand the concepts and the risks.
4. Training of Quality Units (and Regulators) is one key to success now.
5. You need to have a framework around ML and Data governance in place; one speaker called it “good digital practices”.
6. The responsibility stays always with the human!
7. Make the model as simple as possible but not simpler (following Einstein’s principle of simplicity)

GxP-CC is very happy to bring in our strength in the above-mentioned points 3,4 and 5. Feel free to reach out to us anytime!