Health-based exposure limits (HBELs) were introduced in the European Union in 2015 with very strict deadlines, and followed the introduction of acceptable daily exposures (ADEs) defined in SIPE's Risk-MaPP Baseline Guide in 2010. These limit guidelines were established identify exposure risk in facilities that manufacture multiple products.

It has since become apparent to the inspectors that manufacturers were slow to adopt the guide approach and many did not have the expertise within their organizations to deliver HBELs.

Additionally, due to difficulties and inconsistencies in the application of previously used approaches in setting cleaning validation limits to the variety of pharmaceutical dosage forms, there was lack in consistency and consequently a lack in a proper risk assessment associated with carry-over.

This webcast will review:

• What are health-based exposure limits and why is this method better than previous methods used in cleaning validation?
• What are connections between HBELs used in GMP manufacturing and occupational exposure limits (OEL) used in industrial hygiene?
• What are good practices in applying HBELs to small- and large-molecule pharmaceutical manufacturing operations?

• Describe the applicability of health-based exposure limits (HBELs), such as occupational exposure limit (OEL) and permitted daily exposure (PDF).
• Identify the key ingredients of HBEL documentation.
• Use the HBELs in risk assessments for carry over and worker safety in multipurpose drug manufacturing.

Professionals who work or are involved in GMP manufacturing and occupational health including:

• Manufacturing associates and managers
• Laboratory associates and managers
• Production managers
• Quality assurance associates
• Project leaders
• GMP inspectors
• Toxicologists