0      0

2021 APAC Pharmaceutical Manufacturing Conference and Global Regulatory Summit

VL21CEJUN1/SESCS1 - CASE STUDY 1: Practical Applications for OOS Investigations/Assessments

Jun 17, 2021 5:00am ‐ Jun 17, 2021 5:40am


CASE STUDY 1: Practical Applications for OOS Investigations/Assessments | Background to case-studies that will be addressed: Issues observed included observations of repeat testing until a better and/or passing result is obtained; maximum number of retests NOT specified in SOP; vary based on variability of method and is adjusted during OOS Investigation; multiple attempts of retesting and different definition of “retesting”; disregarding OOS results and failure to thoroughly review unexplained discrepancies; product quality failures are ignored without scientific justification. Testing into Compliance: averaging of failed replicates; finding a flaw in the analysis after the run (e.g., Analyst failure/error/ SST/ QA oversight/ Decision making in QC); failure to extend investigation to other batches.


  • Georg Singewald, PhD, VP, Head of Global Quality Control, Genentech, A Member of the Roche Group
  • Aditi S. Thakur, Senior Pharmaceutical Quality Assessor, FDA/CDER/OPQ/OPF

You must be logged in and own this session in order to post comments.