News about GMP/cGMP

20.07.2021

PIC/S: Guidance on Risk Assesment of Routine on-Site Inspections with COVID 19

PIC/S: Guidance on Risk Assesment of Routine on-Site Inspections with COVID 19

PIC/S published a new guidance COVID-19 Risk Assessment for Routine On-Site Inspections” (PI 055-1) which entered into force on 15 July 2021.

The guidance is addressed to inspectors and covers the actions to be taken during the planning phase of an inspection, in consultation with the site to be inspected.


Following, the site must confirm that the necessary measures identified in the risk assessment are implemented before inspection. The document lists all points to be considered for the risk assessment of an inspector while planning. This includes a risk rating into three categories from low to high risk (unacceptable).

If facing an inspection during COVID-19, check out the required measures.


Source:

PIC/S: PI 055-1

 


 

Comments