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An Exercise in Quality Risk Management




The terms extractable and leachable (E&L) have almost become a grammatical contraction for some, but this is a mistake. The terms are distinct and must not be blended into one. When fully understood, both are essential and complementary with different roles in quality risk management.

The Difference Between Extractables and Leachables

‘Extractable’, and its accompanying term ‘extractable study’, was coined to describe a wide number of experimental studies conducted on materials used in pharmaceutical packaging, devices, and manufacture to generate knowledge and understanding of the impurities found in these materials under study. Which system one chooses to study is directed by need and experience. This topic area of E&L was created from a realisation that the quality of the packaging system used in some dose forms was a potential contamination source for drug products, and thus a risk to patient safety.

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About the author


Jason Creasey recently set up Maven E&L to provide independent consultant advice in the area of E&L. He has worked in this topic area since the mid-1990s. Prior to setup, Jason was the Director of a team of analytical chemists providing GSK’s global R&D support for E&L activities. This included: biopharmaceutical and small molecules such as inhalation, parenteral, and cell and gene therapy use. He has been a member of several external groups concerned with best practice guides for E&L issues and continues as a scientific advisor to Extractable and Leachable Safety Information Exchange.
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