RE: Facility layout for cephalosporin and carbapenem sterile FDFs Contribution from JD Mallet written on 7/18/2008 at 19:46
Original contribution: Facility layout for cephalosporin and carbapenem sterile FDFs written by Marina Oskomic on 7/17/2008 at 16:10) This is a terribly tricky question because they are very few regulatory documents on the topics and a lot of talks... I just wish to launch a debate, here on this forum ! To me the answer would be : not possible on the same production line unless fully validated + tested before starting a new camapaign and, for the second proposal, yes on two different line inside the same building provided the containment solutions are fully validated.
Any other opinion ? Or precise written regulatory expectation for penems ?
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