I am interested in understanding the what is the sequence of Area Qualification, HVAC Qualification and equipment qualification. Which is first?
What is the definition of area qualification and room qualification ?
During validation activities which activity is performed first?
Area Qualification
HVAC Qualification
Utilities Validation
Equipment Qualification
As far as I know, there is no defined order. What you have to consider is what the dependencies are. For example, if you do Equipment Qualification (that relies on the utilities) and then find that the Utilities failed, you obviously don’t have data on the equipment qualification that you can rely on / use. Map out the dependencies as part of your overall Validation (Master) Plan and then just follow the plan!
Hi Jay, it’s a question of logic only. You’ve to consider the impact of one step on the other one.
Some example.
Can you start utilities qualification before HVAC group validation ?
Yes you can execute IQ(s) in parellèle but you need to closed ur PQ Environnemental monitoring before starting utilities validation which need to be executed in clean room.
In our case (and this need to be planned and clearly detailled in the validation plan i think) :
1 - IOQ HVAC with all C&M activities depending on the Grade)
2 - IOQ utilities
3 - PQ Environnemental monitoing for Room and Laminar flow if applicable
4 - PQ utilities
5 - then IOQ and PQ equipement
regards
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