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Media fill trials should be carried out over a semi-annual basis for each aseptic approach and extra media fill trials ought to be carried out in the event of any adjust in procedure, methods or products configuration.The intention of this paper is to explain the media fill test process from the context of ATMP manufacturing, in particular of Cytok
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The review prerequisites inside the EU PQR for MA variations, currency of technological agreements, plus the postmarketing commitments tend not to mirror The everyday industry follow for PAR/PQR, and there were sector responses that Many of these review needs appeared to be exterior the scope of the PQR. The review necessities for MA and postmarket
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