Process validation

Hello sir this is Jignesh
my Query is if we planned three consecutive batches validation & suppose only one batch is executed and then production planning not done for the two year then after two year if planning of product manufacturing done then can i considered that one batch executed earlier two years ago?

If all parameters which were applied two years ago remain same then it can b considered

1 Like

It is better take three batches at the same time.

Period or revalidation should also be considered

What if there is no batch in plan for manufacturing?

No activity in mfg area.

Then accordingly you shold prepare the protocol concurrrent validation execute this year one then next year two.