Search results with tag "Pqri"
Current Practices in Shelf Life Estimation - pqri.org
pqri.org• Real-life example contributed by one of our PQRI members – 26 stability batches – all on same product – most kept on study for 24 months – assay was measured • will use to study empirical distri butional properties of estimated shelf life using 3- and 6-batch studies Pharmaceutical Stability Shelf Life August 1, 2010 14 Product ...
Process Robustness – A PQRI White Paper
pqri.orgA PQRI White Paper www.ispe.org/PE_Online_Exclusive NOVEMBER/DECEMBER 2006 PHARMACEUTICAL ENGINEERING On-Line Exclusive 3 ©Copyright ISPE …
Risk-based Environmental Monitoring - PQRI
pqri.orgRisk-Based Environmental Monitoring Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI
Thresholds and Best Practices for Extractable and Leachables
pqri.orgOverview 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
Study Protocol – Stage 1 Amendment #1 - PQRI
pqri.orgPODP Issued and Effective Leachables and Extractables Working Group September, 2011 Experimental Protocol for Plastic Material Test Articles, Stage 1, Amendment #1
THE USE OF STRATIFIED SAMPLING OF BLEND AND …
pqri.orgFinal PQRI Blend Uniformity Working Group Recommendation to FDA December 20, 2002 Page 3 of 15 1. The test should be simple to perform, maximizing the use of …
FDA/PQRI Conference on Advancing Product Quality
pqri.orgBiopharmaceutics Classification System • BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal
Harmonization of Requirements Between ICH Q3D …
pqri.orgHarmonization of Requirements Between ICH Q3D and Pharmacopeias Kahkashan Zaidi, USP PQRI/USP Workshop on Elemental Impurities March 31 – April 1, 2015 USP Rockville, Maryland
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PQRI, Process Robustness – A PQRI White Paper, ISPE, Risk-based Environmental Monitoring - PQRI, Risk-Based Environmental Monitoring, Practices for Extractable and Leachables, FDA Conference on Advancing Product Quality, Study Protocol – Stage 1, Protocol, Stage, PQRI Conference on Advancing Product Quality, Harmonization of Requirements Between ICH, Elemental Impurities