RE: RE: dedicated facilities Contribution from JD Mallet written on 6/27/2008 at 09:48
Original contribution: RE: dedicated facilities written by Jan Schuler on 6/27/2008 at 09:03) To manufacture non-betalactams antibiotics in a multipurpose facility is quite a common situation. To my knowledge there is no absolute requirement to manufcture these products in dedicated facilities/equipment. But, for sure, this will depend on the very nature of these products (pharmacological characteristics like toxicity and industrial characteristics like cleanability) and, moreover, of your cleaning validation program.
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