CMC and MSAT
CMC
Chemistry Manufacturing and Controls (CMC) involves developing, testing, documenting, and registering a new pharmaceutical product, the production process, and the associated analytical methods. CMC project teams with delegates from the Process and Analytical Development, Production, QC, QA, and RA departments are responsible for all deliverables required in Module 3 of the regulatory dossier for a new (bio-)pharmaceutical product.
Even after market approval, the CMC project team can remain involved when process changes and/or scale-up for a commercial process need to be implemented. This also includes new process validation runs and changes to the regulatory dossier that must be approved by regulatory authorities.
MSAT/ASAT
Many (bio-)pharmaceutical manufacturing organizations have implemented Manufacturing Sciences and Technology (MSAT) and/or Analytical Science and Technology (ASAT) departments in their GMP Operations organizational charts.
The MSAT and ASAT departments have a strong supporting role towards the commercial manufacturing departments and the QC department, respectively. By integrating scientific principles and advanced technologies, the MSAT/ASAT department plays a crucial role in optimizing production processes and analytical methods and ensuring the consistent and efficient manufacturing and testing of (bio-)pharmaceuticals throughout the product life cycle.
