In routine working after how many years process revalidation is recomended?
Atlest once in year
why?
any guidlines?
As per PDA TR 60, Continuous life cycle approach can be usedā¦
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.
Sir,plz refer
WHO annex 3,TRS 992
US FDA 070776
once in a year and maximum can be extended up to 3 yrs.
in routine practice once in a year is not followed,why?
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it should be followed once in a year.
any guidlines?
Revalidation for the equipment which are criticalāsupposed to be revalidated every yearā¦
As a process revalidation every year is not feasibleā¦
Yearly revalidation for products Either you can cover with APQR or as continuous verification approachā¦
Thanks
5 years