HVAC qualification by supplier/contractor

In pharma industry, any new installation or major upgrading of HVAC (Heating, Ventilation and Air Conditioning) servicing the processing area requires qualification.

Seems to me that most of our pharma industries adopt a safe attitude by requiring qualification as part of the requirements which a potential supplier or contractor has to comply. This trigger the supplier or contractor to look for a GMP consultant and work with them on the qualification work. Thus, it goes on that the Qualification Plan, URS, DQ, IQ and OQ protocols and reports are all being prepared between the GMP consultant and the supplier. Occasionally, the user is approached for some verification and signatures.

However, this is not a healthy scenario. Industries should be the party directly responsible for the qualification work. If they do not have the expertise, engage a GMP Consultant under them - do not let the GMP consultant be under the 'control' of the supplier.

The reason I say this is due to the fact that the qualification actually ensures that the work done by the supplier or contractor met the approved design and GMP requirements. If the GMP consultant is under the control of the supplier or contractor, he will find difficulty in conveying the problem to the supplier. Worst, if any part cannot be approved (or qualified), the GMP Consultant will face the wrath of the supplier...! How can he then ensure that the HVAC system be well constructed and supplier/contractor do not cut corners....?

Think about it and in your next project, do not allow the GMP consultant to be working under the supplier or contractor.

AJ.