Regulatory Open Forum

Hi all,

I woulld like to have your opinion about the necessity to redo a validation for a cleaning process which remains strictly identical to the initial one except that we have change a old tank by a new one with identical specifications (same brand, same reference, same specifications).

Any opinion on this ? Thank you.

Hi all,

I woulld like to have your opinion about the necessity to redo a validation for a cleaning process which remains strictly identical to the initial one except that we have change a old tank by a new one with identical specifications (same brand, same reference, same specifications).

Any opinion on this ? Thank you.

Hi all,

I woulld like to have your opinion about the necessity to redo a validation for a cleaning process which remains strictly identical to the initial one except that we have change a old tank by a new one with identical specifications (same brand, same reference, same specifications).

Any opinion on this ? Thank you.

Seems a risk assessment is available since the actual celaning process is not changed. If no impact to the product safety and effectiveness, no need to redo a validation 

Hi all,

I woulld like to have your opinion about the necessity to redo a validation for a cleaning process which remains strictly identical to the initial one except that we have change a old tank by a new one with identical specifications (same brand, same reference, same specifications).

Any opinion on this ? Thank you.

Hello Quang,

With everything remaining "equal" then documenting a justification for why a full re-validation is not necessary, doing the IQ/OQ of the new tank, visiting the risk assessment as others have mentioned, and then documenting the change, probably would not need a new cleaning validation.  Maybe a "small" cleaning verification could be done just to make sure everything was connected correctly and indeed showing everything is the same.  Because even though the tank is exactly same specifications and such, it is still a different tank - and when you disconnect hoses and reconnect hoses, funny things do sometimes happen.

Seems a risk assessment is available since the actual celaning process is not changed. If no impact to the product safety and effectiveness, no need to redo a validation 

Hi all,

I woulld like to have your opinion about the necessity to redo a validation for a cleaning process which remains strictly identical to the initial one except that we have change a old tank by a new one with identical specifications (same brand, same reference, same specifications).

Any opinion on this ? Thank you.