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Due Diligence for Leachables and Extractables in a Modern GMP Environment
extractables

Due Diligence for Leachables and Extractables in a Modern GMP Environment

Regulatory guidance for extractables and leachables exists, but only provides general recommendations for ensuring patient safety. Diane Paskiet, Laura Stubbs and Heike Kofler at West Pharmaceutical Services provide an overview of extractable and leachable science.

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