DSM and the FDA undertake joint PAT project
Provider of custom manufacturing services, DSM Pharmaceuticals Inc, and the Food and Drug Administration (FDA) are to collaborate on a project involving Statistical Quality by Design Methodology during Pharmaceutical Manufacturing.
Provider of custom manufacturing services, DSM Pharmaceuticals Inc, and the Food and Drug Administration (FDA) are to collaborate on a project involving Statistical Quality by Design Methodology during Pharmaceutical Manufacturing.
The goal of this project is to recommend changes that support the pharmaceutical manufacturing sector's focus on proactively managing manufacturing processes. This will further enable the sector to reduce waste, enhance efficiency and manufacture drugs with improved consistency and quality.
Dr Barry Gujral of DSM and Dr Maziar Kakhi of the FDA will jointly work to build mathematical models using Quality by Design, Statistical Process Control, Design Space and Risk Analysis methodologies.
The project is in line with the Process Analytical Technology Initiative the FDA released in September 2004 to bring more innovations in Pharmaceutical Manufacturing. "This initiative with the FDA is a big step toward developing more innovative processes in the manufacturing of pharmaceuticals and will benefit current and future customers by improving efficiencies in the manufacturing process," said Terry Novak, president and Business Unit director for DSM Pharmaceuticals Inc.