Transcription of Thresholds and Best Practices for Extractable and …
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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)
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
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VOLUME M – METHODOLOGY, Best Practices, PMO Best Practices, PMO) Best Practices, Internal Branding Best Practices Study, Project Management Office Best Practices, Oracle, Best practices for portfolio rebalancing, Vanguard, Best Practices for Incorporating Social Media, Appendix M: Validation Procedures for, Appendix M: Validation Procedures for Quantitative Food