From Molecule to Market: How AI is Transforming CMC Strategies

Tue, 26 Aug 2025 07:13:14 +0000

During all stages of drug manufacturing, GMP compliance is necessary. AI-enabled surveillance is capable of tracking environmental data and equipment performance, as well as production records in real-time. Through GMP consultation, partnering with a GMP consultant will also make sure that these AI systems are placed to fit within regulatory environments, with a proactive compliance rather than a reactive one. The lack of coherent documentation and consistency in documentation often postpones regulatory submission. The AI has the potential to automatically extract, arrange, and validate the data originating from various sources, minimizing the number of mistakes and accelerating the process of giving approvals.