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.
Julie Barthuet
Advertisement
Julie Barthuet is head Regulatory CMC&D Vaccines at Sanofi Vaccines.
Articles by Julie Barthuet
Advertisement
Latest Updated Articles
Advertisement
Advertisement
Trending on BioPharm International
1
Why Flexibility and Commercial Viability Must Be Built-in Early for Scaling CGTs
2
How Rentschler Biopharma’s New Platforms Aim to Accelerate Biologics Development in Asia
3
Analyzing the Safety and Scope of Next-Generation Gene Editing Platforms
4
