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). The HBEL is calculated for the Active Pharmaceutical Ingredients (APIs) or residual solvents, considering all the available clinical, non-clinical, pharmacological and toxicological data.

The HBEL value helps to establish the cleaning validation requirements in the manufacturing facilities, by determining the limits that must be met. The pharmacology (efficacy) data, examination and interpretation of toxicology/safety data, information on the route of administration, and other considerations are the requisites for deriving the HBEL value of a given active substance. Therefore, to identify risks and ensure safety and efficacy, the determination of scientifically proven threshold value is recommended across the global pharmaceutical companies. However, the manufacturers should be aware of the following, to mitigate the risks at an early stage.

  • The History of Health Based Exposure Limit (HBEL)
  • General Methodology and Approaches for Determination of HBELs
  • HBELs for Highly Toxic Substances with Sensitization Potential
  • HBELs for Excipients, Intermediates and Cleaning Agents Used in Cleaning Validation
  • Importance of Experience and Credentials of Toxicologist in Determination of High Quality Scientific HBEL Monograph
  • Regulatory Expectations and Concerns on HBEL Monographs

To give a detailed perspective on HBEL, Freyr has scheduled a free webinar on, “Health Based Exposure Limits (HBELs) - Regulatory Expectations and Challenges”, scheduled on October 13, 2020, EDT/EST – 10:00 AM | CDT – 9:00 AM | BST – 3:00 PM. Would you like to gain exclusive insights? Stay safe. Stay informed.



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