Process validation when changing location

[snoopy2017]

Hello everyone,

I am having trouble wrapping my head around the concept of process validation. A company used to use a contract manufacturer to make a device. In this process, it is not very clear to me whether process validation was completed before the contractor began manufacturing. . Now that the company brought this manufacturing in house, do they have to complete process validation, assuming it was completed by the contractor?




Thanks.

 

[Bev D]

Rather than simply providing an answer, let me ask you what the standard says about process validation? What purpose do you think process validation serves?

This path of discussion will help you understand process validation rather than simply remembering what we might answer...

 

[Marc]

Just to add - Whether medical devices, automotive, or other industries, process validation requirements are typically quite similar or the same. Yes, see what your relevant standards say, but there are also customer specific requirements and there are "good manufacturing practices" to consider.

I have seen this asked (and discussed) in a number of ways in discussions here, such as "What if we move a production line from one site (facility) to another?", and "What if we move a line from one location in our plant to another location in our plant?"

Some thoughts: Process Validation - Production Line Transferring to a Different Facility

You also may want to read through some of these: Various Elsmar process validation discussions

 

[Golfman25]

Frankly, a lot depends on what manufacturing processes your talking about. We moved a bunch of stamping dies and presses. And of course our customers wanted "re-validation." It was a complete waste of everyone's time.

 

[Marc]

I have gone through the same, and several times we had to completely remove and replace the factory floor where the presses were to be relocated. The assumption that all areas of the factory floor were the same was false. If it's a small press it may not matter. Bigger presses - They're a different animal.

 

[Golfman25]

I have gone through the same, and several times we had to completely remove and replace the factory floor where the presses were to be relocated. The assumption that all areas of the factory floor were the same was false. If it's a small press it may not matter. Bigger presses - They're a different animal.

Like I said, it depends. People shouldn't apply the same criteria to an 800 ton press that they do to an 80 ton press. Two different animals, should be subject to different criteria.

 

[ScottK]

Like I said, it depends. People shouldn't apply the same criteria to an 800 ton press that they do to an 80 ton press. Two different animals, should be subject to different criteria.

With that in mind one should have a risk analysis and rationale for equipment that is not to be re-validated/re-qualified to be ready to defend the decision.

 

[ScottK]

So I was in med device and we moved an entire facility so I have some experience with this...

This sub-contractor you purchased - what I'm not clear is are you moving any of the equipment or just absorbing the existing site in to your QMS?

 

[snoopy2017]

Thanks for the reply. We are not absorbing the site. The manufacturing operations were previously done at a local contractor. But we decided not to outsource this and set up manufacturing operations in house.

 

[Bev D]

If you are bringing the process in-house, process validation is the right thing to do regardless of what the standard or your Customers require. You will have different facilities, different operators, and potentially different equipment with different parameter settings. If you are changing raw material suppliers you will have to validate the different sources of material.


I still advise you to read the standard - and any Customer requirements - to further your understanding of the requirements. Then return if you have questions regarding the requirements. A simple response as to what is required will only help you ‘remember’ what to do, but it won’t help you truly understand the requirement.