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Diane Paskiet, Director, Scientific Affairs, recently published, “The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP),” in thePDA Journal. PQRI is a non-profit consortium involving industry organizations, academia and regulatory agencies that together provide recommendations in support of regulatory guidance to advance drug product quality.
This article provides an overview of extractables and leachables in drug products and biologics, and discusses the PQRI Work Plan and Protocols developed by the PQRI Parenteral and Ophthalmic Drug Products Leachables and Extractables Working Group.
Read the full text here: http://journal.pda.org/content/67/5/430.full
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