EMA RELEASES GUIDELINE ON REAL TIME RELEASE TESTING

BY KEITH NUTHALL THE EUROPEAN Medicines Agency (EMA) has released guidance for pharma manufacturers on using real time release testing (RTRT) assessments of processes rather than end product testing. Its advice expands existing advice - which has covered sterilised products to - medicines and biomedicines. Noting RTRT systems need to give "assurance that the product is of intended quality, based on the information collected during the manufacturing process, through product knowledge and on process understanding and control," EMA argues they can be more ...


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