Recording from Thursday, February 20, 2020

This webinar addressed the impact of multi-sourcing of excipients on the manufacture, quality, safety, and efficacy of drug products. The webinar covered assessment of each excipient source (for equivalency/comparability) in terms of fitness for purpose in a given drug formulation/product, and the potential impact of changing source from a pharmaceutical formulator's perspective. Reliance solely on specification equivalence may miss differences in other excipient properties, such as composition profiles. Impurities may be a misnomer especially if minor components contribute to the functionality of the excipient. Other supplier considerations include GMPs, process capabilities and reliability.

Supplier inequivalence in finished product performance is a Critical Material Attribute awaiting specification!

Learning Objectives
> The implications of excipient variability and sourcing and the means by which risk can be minimized.
> How excipient from different manufacturers can perform differently in a drug formulation and could have an impact on a user’s quality systems
> How excipient complexity contributes to unpredictable product performance
> How to mitigate excipient-related risk