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Multiple Machine Validation

Our company is starting the process of validating packaging equipment. We have one area that has 20 sealers that are “identical”. Do we have to perform an IQ, OQ and PQ on each of the 20 machines or can we validate one packaging machine and use that information to justify the validation of the other 19 machines?

This is a sterile medical device product

Interesting question and interesting problem!

Different companies deal with this scenario differently.

I have seen a similar situation where one instance of a machine was validated
fully and a risk assessment was generated to detail the level of testing that was required for the other 10.

In your case I would certainly do a full IQ on all 20 instances. If the OQ is mainly functional in the sense that there is software associated with the machine then I would demonstate like for like and perhaps some kind of partial OQ.

Are there labels assocaited with this machine, how critical are they and have you the resources available.

Some questions I would ask myself.

[quote=David]Our company is starting the process of validating packaging equipment. We have one area that has 20 sealers that are “identical”. Do we have to perform an IQ, OQ and PQ on each of the 20 machines or can we validate one packaging machine and use that information to justify the validation of the other 19 machines?

This is a sterile medical device product[/quote]

Dear David,
My opinion is:
That although there is a rational on your question however an auditor would demand by you to prove that by validating one equipment you can verify that the rest 19 would operate under their spcefications.

Since such a rational is rather difficult for you to justify / satisfy auditors and taking into account that each one of the equipments are different units that will operate and you will have to evaluate them, I would perform separate qualifications for each one of them.

Best regards,

[quote=David]Our company is starting the process of validating packaging equipment. We have one area that has 20 sealers that are “identical”. Do we have to perform an IQ, OQ and PQ on each of the 20 machines or can we validate one packaging machine and use that information to justify the validation of the other 19 machines?

This is a sterile medical device product[/quote]

Dear David,
although there is a rational on your question, however you should bear in mind that at the end of the day your rational (on validating one equipment) shall be fully justified and should satisfy your auditors.

On the other hand, it is my strong belief that such a rational would not provide enough evidence and since we are discussing about several items (although identicals) I would proceed with all the triplet of IQ/OQ/PQ for each one separately.

Especially on PQ I would three runs of all the products passing by the specific equipment.

Best regards,

I agree, a risk assessment performed upfront would help with the decision, otherwise

A full IQ on all 20 units to confirm that the same hardware/software, critical components, etc are identical on all units. Only then can one assess the possibility and/or the extent of a partial OQ, remembering that one still has to have a fully qualified (completed IQ,OQ,PQ) piece of equipment to base your partial OQ assessment on.

To get to the point, answer these 2 questions.
Do you have full confidence and evidence that ALL items are EXACTLY the same? and
that all 20 units will perform EXACTLY the same?

If not, full qualification is the only way to go.
Hope that was some help.

A couple of thoughts

  1. The straightforward answer is: If you want to “gold plate” your validation and minimize your chance at negative audit feedback do IQ, OQ, and 3 PQ on all machines. Of course this comes with a large opportunity cost in terms of material and personnel resource.

To me this is the starting point though. It is on me as a validation professional to consider if I can present good scientific rationale that would lessen that amount and while still meeting the requirements of regulatory authorities

  1. Your requirement is to establish documented evidence whcih provides a high degree of assurance that a specific process will consistently produce a product meeting it’s predetermined specs and acceptance criteria. Can you do this by doing 1 PQ batch on each machine? Can you do less than that?

The way to accomplish this is by having strong understanding of your process and understanding the risk associated with the step. Is failure of the process resulting in patient injury? Is it going to result in an inconvinience for the patient but no safety issue? Is it only a matter of business risk?

  1. I think it is critical to draw the distinction between the qualification of equipment and the validation of processes. No matter what you do to validate the process all your machines should be qualified in my opinion. If the machine uses a common software package perhaps that could be validated and then the version confirmed on each machine to save work.

Nice thread - more great advise.

I would say that whatever way you choose to do this, make sure that you justify your decision perhaps in the Risk Assessment document.

If you can prove that all these pieces of equipment are indentical (which is key) then I would go for the full IQ on each machine (This must be done in my view) then I would go for the partial OQ, if it has been justified that each equipment is like for like.

Performing a full process run as part of the PQ is also good practice and will give confidence that all machines work as intended.

Excellent discussion guys!

Just found this forum the other day and want to thank all that responded to my question. Excelletn feedback from all of you and it definitely helps in “charting” our way through the issue. Thanks again