EMA Takes Flexible Approach In Setting Exposure Limits for Drugs Produced In Shared Facilities
The European Medicines Agency on April 30 issued a
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The group representing international pharmaceutical inspectorates, PIC/S, has issued new guidance on controlling cross-contamination in shared facilities. It has also transposed several EU guidelines on good manufacturing practice that non-EEA participating authorities can adopt on a voluntary basis.
The European Medicines Agency is inviting feedback on a draft guideline that explains how companies that make different medicinal products at shared manufacturing facilities should review and evaluate pharmacological and toxicological data of individual products to tackle cross-contamination issues1.
Action responds to methanol contamination in hand sanitizers manufactured in Mexico and marketed in the US under numerous brands that followed a loosening standards for the products to drive a swift increase in production and meet surging demand during the coronavirus pandemic.