Michel Crevoisier

Six years after the guidance, it’s time to change our quality assurance vocabulary.

The industry needs a single standard cleaning limit at 25 mg/m2.

Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.

The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.