Design of Robust and Sensitive Extractables and Leachables Studies

To ensure patient safety, precise knowledge about potential contamination associated with a drug product container closure systems (CCS) or single use process equipment is critical. As the complexity of materials and construction of CCS or process equipment increases, the risk of leachables being introduced as drug impurities increases significantly. Authorities are focused on accurate determination of leachables present in the real drug matrix and this demands the need for sensitive and robust analytical effort and interpretation of complicated complicates data.

During this presentation, our expert, Dr Tino Otte, Head Consulting at Intertek in Switzerland, focuses on how to design a robust extractables and leachables study design which covers all necessary steps to meet regulatory expectations whilst highlighting potential challenges of such a study with strategies and examples of how to address these challenges.

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