Health Based Exposure Limits (HBELs) - Regulatory Expectations and Challenges An Informative Webinar
Pharmaceutical companies sometimes manufacture the products using multipurpose manufacturing facilities to develop different medicinal products. Production at such facilities may create potential cross-contamination and pose a risk on products’ safety and efficacy. Hence, toxicological risk assessment is of utmost importance, to evaluate the possible risks of cross-contamination for medicinal products. The risk assessment is done by establishing a cleaning validation program, which comprises a scientifically based threshold value - Health Based Exposure Limit (HBEL).