GxP Processes and Risk Assessment - ICH Q9 Quality Risk Management

v9991

Trusted Information Resource
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.
 

Stijloor

Leader
Super Moderator
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.


Can someone help?

Thank you!!

Stijloor.
 
Top Bottom