Hi All,
Based on the calculation factors [maco], we are deciding a limit in cleaning validation & doing analysis with respect to that for equipments.
Is the OOT concept [Alert / Action] level in cleaning validation required ??
Opinions please !
Hi All,
Based on the calculation factors [maco], we are deciding a limit in cleaning validation & doing analysis with respect to that for equipments.
Is the OOT concept [Alert / Action] level in cleaning validation required ??
Opinions please !
Dear Mr.Ashish
Generally out of trend limits applying for regular analysis and trend range fixing from past history. In this case we were fixing the acceptence criteria based on the carryover calculations and the fixed limits has been validated.
I am appreciating your approach to fix the alert limits for cleaning results, its a new approach and it will be implemented for better control in the cleaning process and carryover.
but the following concerns i am having are…
So many complications will be arrived for implementation of OOT procedure for cleaning of equipments and no specific guideline insisting for the same.
However if it will be get implemented, its highly appreciated. All the best…
Regards
Dear Jyopravel,
what should we do when the testing results are out of alert limit and action limit?
Thanks,
Thuy
You should start a deviation or exception or investigation (whatever your company calls a OOS) and investigate the cause of the OOS, correct it, and documente everything you do. This is a process upset and needs to be handled as such.
No, it a matter of compliance. It either is or isn’t. No alert or action limits required!