[quote=ilu]Is it regulatory requirment to produce 3 consecutive batches for process validation, if it is can some one provide the reference of FDA/MHRA etc.
If the product is produce once in a year, how it will be validated 3 times or is it saleable in market without producing 3 batches?[/quote]
I know of products where 1 batch is produced once every few years. You apply concurrent validation.
Also the 3 batches approach is no longer acceptable in at least some countries, like Germany. The relevant guidance is only available in German though
The modern approach is risk based
3 batches are statistically insignificant