Alert / Action Limit in Cleaning Validation

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…

  1. How many batches trend taken to fix the alert/action limts
  2. What is the criteria for fixing the range [Is it applicable asper 3 sigma calculations]
  3. What is the re evaluation criteria [One time activity / periodical assessment for range]
  4. How you derive the limits for action and alert respectively?
  5. If the result exceeds action limits, the equipment will be cleared for next product
  6. If one of the equipment carryover result exceeded action limit, what action would be
    taken, Is it eliminate from equipment train? Carryover calculations of other
    equipemnts would be effected?

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…


Dear Jyopravel,
what should we do when the testing results are out of alert limit and action limit?

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!