Host: The Japanese Society of Toxicology
Name : The 47th Annual Meeting of the Japanese Society of Toxicology
Date : 2020 -
Over the past 10 years, Quality Assurance groups within the pharmaceutical industry have changed their approach to developing levels of cross-contamination in drug substances and drug products that are considered acceptable. Beginning in 2010 with the ISPE's Risk-MaPP Guidance document, and continuing in 2014 with the EMA guidance, organizations have moved to Health-Based Exposure Limits (HBELs) that need to be calculated on a case-by-case basis. This is a departure from the older, arbitrary process of dividing the therapeutic dose by 1000. This lecture will examine how companies have developed programs over the past 10 years and will also discuss issues that have been encountered along the way.
