Transcription of Thresholds and Best Practices for Extractable and …
{{id}} {{{paragraph}}}
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.
OINDP Safety Thresholds and Best Practices 3 rd PQRI/FDA Conference on Advancing Product Quality 5 • Safety Concern Threshold ( SCT) Low Risk Leachables Not Identified
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document:
{{id}} {{{paragraph}}}