When new equipment (Blister m/c) is install in area then area qualification is required?

When new equipment (Blister m/c) is install in area then area qualification is required?? If yes , then what is the flow of qualification? 1st we complete IQ OQ PQ then Area qualification perform… please give me suggestion with reference … Thnks in advance …

It is not required to requalify that area. Only we have to qualify new blister packing machine and the associated new utilities (if added) in the area which were not there earlier.

Requalification of that area is required only if major structural changes are done in the layout of that area.

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Also consider that If you had to do major changes or repairs in the area or infrastructure to put the equipment in place, a verification of the area would be useful to verify that its qualification status was maintained, and to update your lay out diagrams and process flow. There could also be some considerations regarding sound and heat transmision by the equipment into the room, if such tests are part of your area qualification.

More considerations would come from a risk assessment as part of the change control system.

I hope these considerations are helpful.

Thnk you so much :blush:

Sir whatv is area qualifications?
Means same parameters like as a AHU?