Marie-Claire Beckers is global subject matter expert for QC Materials and Samples Management at GSK Vaccines.
Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference Standard
September 2nd 2022Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.