(Kopie 8)
We are happy to announce the article by Elke Wieser and Stefan Pauli on “Bridging AI and GMP Standards in the Future of Pharma” which was published in issue 5/2024 of the international magazine “Chemistry Today”.
In their article, the authors examine the integration of Artificial Intelligence in pharmaceutical manufacturing, especially with regard to GMP standards. Regulatory bodies like the FDA and European authorities are in the process of incorporating AI into GxP standards, but formalized guidelines are still under development. The article spotlights a proposed validation framework and real-world examples of AI successfully enhancing GxP-compliant production. Despite the rapid progress, AI adoption in pharmaceutical manufacturing needs a cautious approach to safeguard product quality and ensure patient safety.
Read the article here (in English)