Consult Lhasa is pleased to announce the launch of a new service offering for Health-Based Exposure Limits (HBELs), to support pharmaceutical manufacturers manage cross-contamination risks in shared facilities.
When multiple medicinal products are manufactured within the same facility, cross-contamination risks need to be evaluated. Regulatory guidelines, such as EMA guidance Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities, require pharmaceutical manufacturers to demonstrate that any potential exposure to contaminants remains within safe limits. This evaluation is also known as a permitted daily exposure (PDE) assessment, which is a type of HBEL.
Dr Crina Hedges, CEO of Consult Lhasa, explained: “At Consult Lhasa, we are passionate about improving scientific risk assessments for the benefit of human health. Our new Health-Based Exposure Limits service supports pharmaceutical manufacturers in gathering the valuable insights they need to manage cross-contamination risks, ensure compliance with regulatory standards, and create safer medicines.”
The Consult Lhasa HBEL service offers a structured scientific evaluation of pharmacological and toxicological data to define a health-based exposure limit for a product, considering the other products manufactured within the facility. The outcome will be an actionable threshold value, such as permitted daily exposure (PDE) or threshold of toxicological concern (TTC), ensuring compliance with regulatory standards and safeguarding patient health.
Laura Johnston, Director of Global Business Operations at Consult Lhasa, highlighted the importance of this update: “Thanks to our scientific expertise, we have been able to quickly respond to the interest we have seen in health-based exposure limit support. Our new HBEL service offering reflects the dedication Consult Lhasa has to supporting safer pharmaceutical manufacturing and helping clients navigate complex regulatory landscapes.”
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