Please look at the following below attached file which may help you in your issue.

Thanks

Depends on the regulatory framework of each country.

However, nowadays they try to harmonised them and to be oriented to quality risk management, with a quality systems at all stages of the manufacturing process life cycle:

e.g. https://www.ema.europa.eu/en/process-validation-finished-products-information-data-be-provided-regulatory-submissions

Thank you Sir for your response. Once i will read and come back on this issue.

As Mr. Molteni mentioned ,it depends of regulatory frame work.

If you want to perform process validation based on WHO GMP requirements, 3 consecutive batches are sufficient .In FDA requirement you may need to perform 5 batches.

Hi Nagaraju Rajana

three batches based on which regulatory framework or guideline?

Hi Nagaraju Rajana

Thanks a lot, it is always good to give references.

Please consider "The number of process runs for validation should depend on the complexity of the process or the magnitude of the process change being considered. For prospective and concurrent validation, three consecutive successful production batches should be used as a guide, but there may be situations where additional process runs are warranted to prove consistency of the process".

Three batches should be used but depend on the above consideration.