EMA Clarifies Exposure Limits, Risk-Based Models for the Prevention of Contamination in Drug Manufacturing

The EMA clarified agency expectations on the implementation of risk-based models and exposure limits to prevent cross-contamination during manufacturing in a Q&A guideline, telling manufacturers that all products should have health-based exposure limits (HBEL).

The Q&A guideline supplements a draft document from 2013 on setting health-based exposure limits to identify manufacturing risks — clearing up what products and active substances the EMA deems highly hazardous and how the HBEL model applies to investigational medicines with limited data and facilities manufacturing both pediatric and adult therapies. Furthermore, it spells out the connection between HBEL and GMP requirements and the establishment of cleaning limits.

The EMA identified the following compounds as highly hazardous: genotoxic compounds, such as mutagenic, that are highly likely or known to be carcinogenic to humans; compounds that can produce reproductive or developmental effects at low dosages; compounds that can produce serious target organ toxicity or other significant adverse effects at low doses; compounds with a high pharmacological potency; and compounds a high sensitizing potential.