Hello, does anyone have experience with having to Terminally Sterilize a lyophilized product? We have received conflicting opinions from Sweden and Germany and suspect this is a misinterpretation of the
Draft guideline on the sterilisation of the medicinal product, active substance, excipients and primary container' (EMA/CHMP/CVMP/QWP/BWP/850374/2015).
Can you shed any light or experience with TS on a lyophilized product that is already sterile?
Many thanks!!
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Cynthia Wojtaszek
US Regulatory Liaison
Jackson NJ
United States
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