Validation of 3 batches

In validation of product 3 batches required . During validation if one batch fails ( 2 nd batch ) due machine problem. is it reuired to take next two batches to show 3 bathces consistency ?
Or one batch is sufficent to show consistency between 1,3 & 4 th batch.


In my point of view, if any GMP deviation occured duirng validation batches, we can disqualify the particular batch and go ahead with one additional batch.If any process related deviation observed, then we have to go for next three consecutive batches.In you case, since there is a failure in the machine, we can take one additional batch to complete the validation. This deivaiton to be discussed and justified in Validation report.


Three batches is a rule of thumb -not a CFR 210/211 requirement. You can get by validating one batch if you have a sound scientific explanation. -but it better be good! :smiley:

In view of your case due to machine failure, you can take another fresh batch as third validation batch and make failure report for 2 nd batch.In view of another people responce there is no such guideline to take three btaces to complete the validation but for any final conclusion we required sufficeent data which is not possible from by taking only one batch.