BioPhorum member only content. This is detailed consultation response from BioPhorum Supply Partner to USP on draft monograph <1083>.
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This BioPhorum paper contains feedback on the USP bioreactivity monographs to plastics used for manufacturing, and the use of resources. It also comments on the potential in vitro tests that should be included, the removal of the implantation test and safety, the removal of Class I to VI, and the topics for omission or inclusion into the <1031> chapter outline. The expert feedback provided in these documents aims to support the USP and, ultimately, produce documents that improve patient safety – but with adequate use of finite analytical resources, which would not be the case with divergent expectations.
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