EMA Urges Assessment of Cross-Contamination Risks During Manufacture of Drugs
Drugmakers and active pharmaceutical ingredient manufacturers in Europe that produce multiple products in one facility should justify exposure to contaminants and follow specific steps to clean equipment and reduce risks of cross-contamination, according to a new EU guideline.
The European Medicines Agency recommended ways to determine threshold levels of pharmacological and toxicological values that may be present in shared facilities. The formula for determining the permitted daily exposure (PDE) amount is based on a product’s hazards, critical effects and no-observed-adverse-effect levels, as well as uncertainties, the guidance said.
A PDE is a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed to this dose every day for a lifetime.
Risks should be considered on a cause-by-case basis, the agency said. Determination of health-based exposure limits may not be necessary for protein-based products because they can be degraded or inactivated by cleaning equipment with pH extremes and/or heat.
Furthermore, active substances and products must be made in dedicated facilities if scientific data does not support an acceptable level of exposure or handling risks can’t be adequately controlled.
The guidance takes effect in June 2015 for products introduced for the first time on shared facilities, and in December 2015 for products already produced in shared facilities.
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