Leachable Risk Assessment Approaches: A Comparison of USP <665>...

Full title: Leachable Risk Assessment Approaches: A Comparison of USP <665>,Biophorum, and Other Methods For Assessing Leachable Risk In Biopharmaceutical Manufacturing Systems There is currently no agreement on a format for a leachable risk assessment approach when applied to a biopharmaceutical manufacturing system. USP and Biophorum have published some guidelines, however both guidelines have (in the opinion of this speaker) some gaps and flaws. This webinar will provide review of the USP and Biophorum guidance and suggest an alternative approach, which seeks to address these gaps. The approach providing both a consideration of leachable risk in terms of both severity of harm and probability of harm, and its associated uncertainty as a result of a biopharmaceutical manufacturing process and its effect on patient safety. The approach outlined borrows heavily from principles outlined in ICH Q9 and has been presented in part through ELSIE’s whitepapers published to their website. Its key recommendations are to establish a process whereby the leachable risk is clearly identified, followed by a scoring of the risk through a risk analysis then a risk evaluation against a pre-agreed risk matrix that will output a clear decision on whether further risk control is required and the risk is either accepted or needs reduction. Subsequent study design and requirement is thus based on these principles, rather than a pre-stipulated design.