Autoclave Revalidation

Validation
#1

Hello to everyone.
I need your view, Suppose for Autoclave(x) the annual revalidation is due on 05/02/18 and due date considering ±30 days is 07/03/18 and i perform study and report prepared after completion of study let 19/04/18, when what should be the next revalidation due for year 2019?
As regular planner should to be 05/02/19
If Considering actual execution is 19/04/19

Meanwhile, let in year 2019 I face Autoclave breakdown, and I revalidated after 3 months as per actual plan 2019, proposing deviation and justifying risk assessment.
And this process continues as is, over period of 4 year, recollecting all I can find a gap of 1 year…So is there is need justification or no as already, I have deviation and assessment done before…!

#2

Hello Asif

We usually plans next requalification’s date considering the initial IQ’s date in despite of the date of the completion of the study or of the report’s approval.
We prefer to shorten the time between the studies that face the possibility of regulatory discussions with some auditor because of delaying qualification studies

Waiting for it to be useful and promote the discussion
Greets you, tania

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#3

Thank you Tania, for the prompt reply and support.

#4

Autoclave validation is done by annually ie… including report approval,if any major down appears with in a short period it shall be qualify as early as possible, if any major break down happens before 2months or earlier,or later it’s better to qualify for break down deviation and after if any shedule appears with in short period it’s better to qualify as shedule to escape from VMP deviation and from an eagle eye from auditor either

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