Module 3 2019

How do we set acceptance criteria? For Example: Specified Impurities

The acceptance criterion for UK-123,456 has been established as 0.7% maximum . This acceptance criterion was based on the following considerations: ● UK-123,456 is a potential process related impurity in drug substance. It is controlled by the drug substance specification to 0.4%. ● UK-123,456 does not form during manufacture of the drug product. ● UK-123,456 is qualified to 1.0% ● UK-123,456 is also a potential degradation product of the drug product and has been observed in stress testing studies on the drug substance. Minor changes in the level of UK-123,456 have been observed during drug product stability studies to date. – Accelerated stability studies using high temperature and humidity and quantified using a modified Arrhenius equation (ASAP) show acceptable shelf life at the acceptance criterion of 0.7%

The Organisation for Professionals in Regulatory Affairs