Determining the feasibility/scope for FDA IQ/OQ against a very simple application

R

robeen

#1
Hello everyone!

Who am I ? I work as a solution architect in a company that offers hardware & software solutions for supply chain and production quality control automation and mobility.

How simple is the software ? We will install on Hair Product Production Line an out-of-box hardware that will automatically work as a standalone device to determine if each produced item meets some standards or not (Barcode is there, Cap is on, Fill level of the product). we will be using this hardware's API to create a very basic desktop application to show some statistics about the passed products and the failed ones.

Where's this company located ? It's an american company but the software will only be deployed in one of it's distributor's factories in Africa (the production will be done and distributed in Africa only).

So what's my problem ? The end-user requested the software to be IQ/OQ compliant.

Again, so what's the problem ? the answer to that question is based on my extensive 10-hour research so please bare in mind that I'm no expert!
So first of all, why would they request a regulation enforced by an American administration, while all the supply chain will take place in Africa. I thought maybe it's a good practice but yet I can't find a thorough article, template available to talk about implementing such a simple tool, even the cosmetics section always referred to the product itself and nothing about the packaging or quality control.


I'm so sorry for the long post but I thought to be as through as possible to be able to get help and related replies. I can't find any firm, documented proof whether I should or shouldn't follow the FDA IQ/OQ guidelines. So I was hoping to get some answered whether am I right or wrong about the above and of course I need to support my e-mail to my direct manager with some proof on why we should or should not invest in this client's request (the IQ/OQ thing). I would like to add one last thing, the client didn't request a DQ or PQ they just need IQ/OQ and also the URS was very poor and not complying by any means with the FDA which made me start questioning their contact person and whether they really know what they are talking about or not!


Thanks you in advance :cfingers:
 
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yodon

Staff member
Super Moderator
#2
A couple of clarifications...
1) FDA does not sanction IQ/OQ (or DQ and PQ) as the means to validate processes / equipment. Those are just commonly used tools.
2) FDA does not have compliance requirements for URSs.

That said, it does sound a bit sketchy. Clearly they want to confirm that the equipment is installed correctly (IQ) and functions as expected (OQ). For such a system, though, it would sound like (presuming following the IQ/OQ... model) a PQ would be in order to ensure the system can maintain performance.

As you say, IQ and OQ are certainly good practice so I would suggest that you just answer the mail: conduct the IQ and OQ as your client requests. Maybe suggest improvements to the URS to strengthen the OQ but if they're not interested, just cover the bases.

Final point: such validations are generally expected to be risk-based; i.e., the level of effort going into validation should be commensurate with the risks (if the process fails). Are there any risks (to end users) if the process fails? If so, you may want to further strengthen your requirements (and subsequent OQ) with a risk analysis / identification of controls to mitigate the risks.
 

v9991

Trusted Information Resource
#3
I agree with Yodon's comment there. Further,
I can't find any firm, documented proof whether I should or shouldn't follow the FDA IQ/OQ guidelines.
Draft Guidance for Industry: Cosmetic Good Manufacturing Practices

You should evaluate laboratory controls including sample collection techniques, specifications, test methods, laboratory equipment, and technician qualifications
the client didn't request a DQ or PQ they just need IQ/OQ and also the URS was very poor .... not complying by any means with the FDA which made me start questioning their contact person and whether they really know what they are talking about or not!
keeping the documentation & responsibilities aside, I would like to guess that, this is being a inspection system, its minimum requirement to have IQ & OQ in place. its often suppliers responsibility to demonstrate same. (in the interest of efficiency, established documentation and system-unerstanding etc.,)

hope this helps.
 
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