Are there any GxP relevant processes which can be assessed low on risk?
'Risk'' i mean by the ''ímpact'' part of the risk described in ICH Q9.
risk = severity/impact x occurrence[O] x detection/control[D].
My perception is that, overall risk (SxOxD) could be definitely evaluated to be 'LOW" but all GxP relevant process can't be always assessed low on impact!
thanks in advance for your thoughts.
'Risk'' i mean by the ''ímpact'' part of the risk described in ICH Q9.
risk = severity/impact
My perception is that, overall risk (SxOxD) could be definitely evaluated to be 'LOW" but all GxP relevant process can't be always assessed low on impact!
thanks in advance for your thoughts.