RE: dedicated facilities Contribution from Jan Schuler written on 6/27/2008 at 09:03
Original contribution: dedicated facilities written by john on 6/26/2008 at 16:44) From a GMP perspective it should be assured that a cross contamination can not occur. I think it would be very difficult to show that this can not happen in a multi-purpose API facility. So from a risk evalualtion point of view, which is required today, I would have doubts that this would be accepted by your customers and or regulatory authority Answers to this contribution:
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