Nudelman ChemTox
Consulting
Qualification of Extractables & Leachable (E&L)
This service addresses the risk of chemical contaminants from packaging or manufacturing components migrating into drug products. Key elements include:
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Comprehensive evaluation of E&L study reports to identify potential and actual compounds that may migrate from the packaging or manufacturing components.
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Evaluating the toxicological impact of identified compounds to ensure they meet safety thresholds.
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Recommend which compounds identified in extractables studies need to be followed in leachables studies.
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Set limits for identified compounds and compare to regulatory accepted limits (e.g. PQRI limits).
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Consider regulatory discussions for E&L being developed in the ICH Q3E guideline working group.
This service ensures the safety of drug products by controlling packaging and manufacturing-related impurities, aligning with emerging ICH Q3E guidelines.