Process validation


(Jignesh R Paghdal) #1

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?


(Sajjad Ahmad) #2

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


(Sabbineni) #3

It is better take three batches at the same time.


(Sajjad Ahmad) #4

Period or revalidation should also be considered


(Meenakshi Gupta) #5

What if there is no batch in plan for manufacturing?


(Sajjad Ahmad) #6

No activity in mfg area.


(ashok dhondappa karpe) #7

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