Process Revalidation


(Sajjad Ahmad) #1

In routine working after how many years process revalidation is recomended?


(Rakesh Kumar chowdhary) #2

Atlest once in year


(Sajjad Ahmad) #3

why?
any guidlines?


(Md.Asif Hussain) #4

As per PDA TR 60, Continuous life cycle approach can be used…


(Madeeha batool) #5

re validation of process is done after any change made in the process. routine re validations of different processes involved in overall process are done according to the defined protocols i.e. once in a year or twice a year.


(Rakesh Kumar chowdhary) #6

Sir,plz refer
WHO annex 3,TRS 992
US FDA 070776


(Sajjad Ahmad) #7

once in a year and maximum can be extended up to 3 yrs.
in routine practice once in a year is not followed,why?


(Madeeha batool) #8

it should be followed once in a year.


(Sajjad Ahmad) #9

any guidlines?


(Md.Asif Hussain) #10

Revalidation for the equipment which are critical—supposed to be revalidated every year…
As a process revalidation every year is not feasible…
Yearly revalidation for products Either you can cover with APQR or as continuous verification approach…
Thanks


(Muhamad Haziq Bin Haslan) #11

5 years