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LEACHABLES AND VIRUSES

This article was originally published in The Gold Sheet

Executive Summary

...are two pharmaceutical product contaminants that are drawing close attention from FDA and industry. For both concerns, an effort is being made to develop more meaningful regulatory standards and guidance that will reflect the potential and the limitations of evaluation and control technologies. Public meetings have been held recently to help facilitate this process. Though the risk is considered very low, TSE is another contamination problem area creating regulatory concern particularly for biologic products. The agency has an "action plan" to try and address the dilemmas involved with TSE and recently issued a revised guidance on preventive measures for blood products.

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