Module 3 2019

Why care about quality?

• Why do the pharmaceutical (quality) aspects of a medicine matter?

… Surely demonstration of safety and efficacy is enough?

• Chemistry, Manufacturing & Control … ● Impurity profile, physical characteristics? ● Formulation, manufacture and presentation fit for purpose? ● Stability? ● Assurance of GMPs? ● Robustness / Reproducibility?

The Organisation for Professionals in Regulatory Affairs