Handling Changes in IQ Stage


(Md.Asif Hussain) #1

Dear All,

How do you handle any changes or modification in IQ stage of an equipment?

Thanks.


(dushyant) #2

Can be handle through unplan deviation as we already review & pre-approved IQ qualification of any instrument/machine/system which is part of IH SOP document or part of vendor qualification document as few organization accept qualification document of vendor only.

Before freezing any conclusion over all assessment required as it is opinion only.


(Md.Asif Hussain) #3

Thanks Mr. Dushyant, 1st of all congratulation as per announcement.

As my concern here was, since the machine is still in qualification phase,still IQ/SAT is going on,machine not release for regular production and the machine is not yet included as a pharmaequipment in your VMP.
i dont think its appropriate to handle the changes/modification in machine through QMS.

It can be handled by mentioning in IQ report itself regarding the changes as outstanding point,ok?

Thanks