Generative artificial intelligence (AI) and large language models (LLMs) have long since become part of everyday working life – including in the pharmaceutical industry. However, especially in regulated environments, the question is not whether, but how AI can be used safely, sensibly and in compliance with regulations. Between efficiency potentials, the EU AI Act, GMP […]
The use of artificial intelligence (AI) is rapidly gaining importance in the pharmaceutical industry – from increasing efficiency in everyday office work to complex applications in GMP-relevant processes. At the same time, regulatory requirements are increasing significantly. The EU AI Act and the planned Annex 22 to the EU GMP guidelines will provide a clear […]
The regulatory requirements in the GMP environment have changed noticeably in recent years. In 2025, it is clearer than ever that it is no longer enough to formally fulfill requirements. Authorities expect comprehensible decisions, stable processes and quality that is actually practiced in day-to-day work. For many companies, this means a fundamental organizational, technical and […]
The pharmaceutical industry is at a turning point. For decades, traditional batch processes characterized the production of pharmaceuticals. Although these have proven their worth, today they are often considered rigid, slow and resource-intensive. Continuous manufacturing opens up a new path: production no longer takes place in individual batches, but continuously and without interruption. This not […]
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