The pharmaceutical industry is going through a period of intense transformation. There is a growing trend to use Artificial Intelligence (AI) and Process Analytical Technologies (PAT) in the production of drugs, with in particular a continuous acceleration of manufacturing processes.
Based on this observation, it is useful to have a global strategy serving R&D, Industrialization and Pharmaceutical and Chemical Production.
Combine the pragmatic approach of "Quality by Design", to define the critical sources of process variability, with PAT (including NIR & RAMAN spectroscopy), to monitor, manage and improve processes to ensure that finished products are manufactured with the desired quality.
- Implementation of a "Quality by Design" approach for the development and control of processes, from R & D to routine operations.
- Implementation of effective process monitoring via PAT systems using NIR technology tools.
- Assistance on control methods and their modifications so that they comply with EMA and FDA requirements.
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