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.
Thierry Gastineau
Advertisement
Thierry Gastineau is Global Head of Quality Advocacy, Culture, & Innovation at Sanofi Vaccines.
Articles by Thierry Gastineau
A case study discussing why post-approval changes present a very low risk, and therefore can be downgraded from a prior-approval to a notification after implementation and managed in the PQS with immediate implementation effect.
Advertisement
Latest Updated Articles
- Industry 1VQ Solutions: Changes That Bring an Additional Restriction on the Product Compared to Registered Conditions
Published: August 16th 2022 | Updated:
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
