Post by A.forall

Innovation is a tool. Expertise is the authority. The US FDA recently issued a warning to a manufacturer for 'inappropriate use of artificial intelligence'. The firm relied excessively on AI to create drug specifications and production records without adequate human oversight. Closer to home, the FAGG (FAMHP) has also raised concerns about the risks of AI in our industry. More specifically about the danger of 'hallucinations' where AI generates plausible but entirely incorrect medical or technical data. This is a critical reminder: technology can assist, but it cannot be held responsible for patient safety. Where the EMA has extended the functionality of its AI-enabled knowledge mining tool, it has also joined forces with the FDA to identify ten principles for good AI practice in the medicine's lifecycle. At A.forall we fully embrace progress while our focus remains on rigorous human-led validation. Mastering complex dossiers and ensuring every detail is right requires expertise and oversight. Whether we are preparing documents for the EU or the US, we ensure that every process is reviewed, verified and compliant with CGMP standards. Our Quality Assurance Director, Sarah Hughes, says it best: “Whether we are preparing documents for the EU or the US, we ensure that every process is reviewed, verified and compliant with CGMP standards.” We supply high-quality and value-adding generics to over 60 countries. There is no substitute for human accountability. There is no compromise on quality. Read more about the followed guidelines, according to the EU GMP Annex 22 on AI: https://lnkd.in/gBSeskcu #FDA #FAGG #EMA #GenericExcellence #AFORALL #FocusToMakeADifference