Regulatory: Feedback to DMKA questions to critical GXP augmented intelligence

The Danish Medicines Agency (DKMA) is working to define criteria for the application of artificial intelligence (AI) and machine learning (ML) across GxP-regulated areas.  To understand the biopharmaceutical industry’s position, it has been gathering information using questions posed as though asked by an inspector assessing the quality of an AI/ML algorithm used to control and evaluate product quality. To form an industry response, BioPhorum gathered a cross-Phorum collaboration team and the response has now been published as Industry Feedback on DMKA Questions to Critical GxP augmented intelligence, and submitted to the DKMA 

The questions considered the requirements and quality of data used to build, test and validate an algorithm, and how it would respond to biases and deviations in results. This situation may soon arise, especially with the introduction of new platform technologies (e.g. continuous manufacturing) that will increasingly use these algorithms.   The response is a critical step in asserting BioPhorum’s position as the partner of choice for the Danish and other European agencies for the global implementation of AI and ML in the manufacture of biologics. 



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Feedback to DMKA questions to critical GXP augmented intelligence August 2021.pdf
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