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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)
Thresholds and Best Practices for Extractable and Leachables PQRI-PODP Working Group Recommendations: Parental Drug Products …
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