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Pharmaceutical Manufacturing and Packing Sourcer

Practical Considerations

Pharmaceutical products interact with a variety of manufacturing and container closure system components during their shelf lives, which may migrate into the pharmaceutical product.

Migratory species may be benign or toxic. They could also react with the active pharmaceutical ingredient (API) or excipients within the product. This could affect product efficacy or, in a worst-case scenario, generate by-products that render it unusable.

The FDA and European Medicines Agency (EMA) require an assessment of these component-product interactions to identify and assess any toxicological risks that consequently arise. These are addressed via extractables and leachables (E&L) studies.

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About the author

Alan Wood has 10 years of pharma industry experience, having worked within the academic and CRO environments. Alan has knowledge across a breadth of analytical techniques and drug product matrices. His primary areas of expertise include method development, investigative LC-MS, and
E&L testing.
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