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Thresholds and Best Practices for Extractable and …
Thresholds and Best Practices for Extractable and leachables PQRI-PODP Working Group Recommendations: Parental Drug Products (PDP) Ophthalmic Drug Products (ODP) 3rd PQRI/FDA Conference on Advancing Product Quality Washington DC, 22 March 2017 Overview of Thresholds and Best Practices for Extractable and leachables (L&E) 3rd PQRI/FDA Conference on Advancing Product Quality Washington DC, 22 March 2017 Diane Paskiet Chair of PQRI PODP L&E Working Group Director of Scientific Affairs, West Pharmaceutical Services Objectives PQRI L&E Mission and Scope Threshold Concept and Extraction Studies Safety and Quality Points to Consider 3rd PQRI/FDA Conference on Advancing Product Quality 3 Mission Statement The Product Quality Research Institute (PQRI) is a non-profit consortium of organizations working together to generate and share timely, relevant, and impactful information that advances drug product quality and development.
Overview of Thresholds and Best Practices for Extractable and Leachables(L&E) 3rd PQRI/FDA Conference on Advancing Product Quality Washington DC, 22 …
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