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© 2023 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Delphine Collete is global subject matter expert for QC Materials Management at GSK Vaccines.
September 02, 2022
Change 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.