CASE STUDY & EXPERIENCE ON SANOFI’S & SGS’S IMPLEMENTATION OF BPOG’S LEACHABLE RISK ASSESSMENT MODEL

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of E&L at SGS.
A brief review of the BPOG’s Leachable Risk Ranking model. A case study of the leachable risk model implementation in Sanofi will be presented. All changes to specific risk factors and weight changes will be discussed. Finally, the lesson learns and experiences of the risk model performances on several projects will be shared.
Followed by Case Study and Experience in Extractables and Leachable Studies of Plastic Process Materials - a CRO perspective
Extractables and leachables (E&L) from the plastic process materials used during pharmaceutical and biopharmaceutical manufacturing can potentially pose risks to the safety, efficacy, and stability of pharmaceutical and biopharmaceutical products.
The USP risk assessment model will be briefly reviewed. Challenges regarding the design of extractions and analytical evaluation threshold (AET) calculation for process materials will be discussed. A few case studies regarding the E&L studies of process materials will be shared.