IQ Requirements

Milas

Starting to get Involved
#1
Hi

Is IQ required for equipment which is being used to build samples for a customer ?

I have been informed that IQ is only required for samples which are required for clinical trials, but not sure how accurate this. Additionally, how far do you go with an IQ, does it depend on the complexity of the equipment ?

Thank you in advance
 
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Tidge

Trusted Information Resource
#2
IQ "Installation Qualification' is a term that only has a precise meaning in the context of the manufacturing of medical devices for which the manufacturer wants to establish objective evidence that the manufactured devices consistently match design outputs.

Additionally, it is possible that some manufacturing equipment (e.g. sterilizers) are necessary to make the devices safe (per the 14971 definition), and would need to be installed correctly.

If neither of the two cases above apply, then I wouldn't require an IQ... but I'd still need to have evidence that the manufactured devices met design outputs (*1) and that the manufactured devices were safe.

(*1) even if the devices are not finalized, they still need to be built to some specification.
 

Ronen E

Problem Solver
Moderator
#3
The main (and first) question in this case is: What are these samples meant for (and also useful: what they are NOT meant for / excluded from)?
 

Milas

Starting to get Involved
#4
Hi

These sample are produced to validate the design against the drawing & specifications and used for different testing and trials by the customer.

We build components and sub assemblies for medical devices on equipment which haven't had a IQ completed. But now been told that all equipment used to build samples need to have an IQ completed which is in line with FDA and GHTF requirements. Not sure how far we go with the IQs without it having an impact to our sample building process. Can we categorise the equipment to determine what needs an IQ and what doesn't ?
 

Ronen E

Problem Solver
Moderator
#5
Hi

These sample are produced to validate the design against the drawing & specifications and used for different testing and trials by the customer.

We build components and sub assemblies for medical devices on equipment which haven't had a IQ completed. But now been told that all equipment used to build samples need to have an IQ completed which is in line with FDA and GHTF requirements. Not sure how far we go with the IQs without it having an impact to our sample building process. Can we categorise the equipment to determine what needs an IQ and what doesn't ?
Thank you for the clarification. That's an interesting twist in the discussion.

From the sound of it, you are not the designer / developer / design owner of the device, so not directly responsible for Design Control and other QA processes, e.g. Process Validation (of which IQ can be a part). You are merely a supplier / subcontractor, not a finished device legal Manufacturer. It seems that your customer is the one bearing these responsibilities, and they are trying to meet some of them through asking/instructing you to complete certain elements. Whether or not this is appropriate depends on the nature of your agreement with them. Do you have a Quality Agreement? What does it say?

Whether a formal, full-on IQ is required in this case is not a clear cut. It also depends on the nature of the components / subassemblies, and the role they play in the finished device (how significant / critical they are, in the bigger picture).
 
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