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hyperopia

05/19/24 2:59 PM

#692619 RE: Doc logic #692279

Doc, I personally don’t think the MHRA will inspect Charles River Labs' (formerly Cognate’s) or Fraunhofer’s manufacturing facilities, since they are not currently being used (or immediately planned) for initial DCVax commercial production.

I think, but I’m not sure if the MHRA is like the FDA, in that they will generally schedule a pre-license or pre-approval inspection of the intended commercial manufacturing facility after the midpoint in the review process, and request to view all phases of the production operations for the selected product under review in the marketing application.

Shutting down operations of a GMP facility for construction, maintenance, cleaning, and disinfection is complex, but routine, and would not effect anything unless a significant change to the plant and equipment occurs, which would usually require requalification. (except that a pre-approval inspection obviously could not be scheduled during the shutdown)