I do not think the processes have to be revalidated because of multiple locations. However, I will add that the quality team may have argued this if they saw that each location would impact the equipment in someway which may change the end results. That is the only way I see the quality team arguing this. If the location influences the end result, then yes the processes would need to be re-validated. I do not have any industry experience so my personal exposure to such cases is limited to none. I may be wrong but thats what I understand from the class notes.

Hi All,

I do not have personal experience in this area however I could see why the quality team would argue that when equipment is moved all processes had to be revalidated. Most likely they were concerned that when equipment was moved it would need to be taken apart and reassembled, which makes room for error. Additionally, if it is simply not setup properly, there may be a change as well. In this case, because the movement to a new location may have caused a change, the process would need to be revalidated.

-Andrew Nashed

If equipment gets moved from one location to another, I do agree that a revalidation would have to occur, but for only certain aspects. There are many validation processes, so I don't believe a full re-validation would have to occur. In this example of relocating the equipment, I believe it would be necessary to revalidate sterility, humidity, and environment checks. Each location is different so I do understand the need to revalidate aspects that deal with the surroundings, but for any software or full operational aspects I don't think it would be necessary.

I had a similar experience, but with the purchase of a 2 identical pieces of equipment, but they were being placed at two different locations. We had to validate each piece of equipment, but with regards to our Test method validation, we only had to do that on equipment due to the fact that they were identical. But with respect to this particular situation, I believe that it depends on the equipment durability and equipment use. For instances, I know certain pieces of equipment can be placed at different locations and don't need to be re-validated they just need to be re-calibrated and a memo for justification from quality could be suffice, if this equipment is used to develop or test an upper level class of device, then I do believe that a revalidation is to be implemented. Ideally, you want to ensure that the equipment is producing the same results like in its previous location.

Chris

I've had similar experiences when moving manufacturing and assembling from one facility to another. Quality will always call for a complete validation for all aspects of the process moving. While you can and successfully argue with and rationalize certain aspects of a complete revalidation, I believe it is always worth mitigating risk and going forth with validation. Rationales can very much so take off much needed time from a relocation project, but in the grand scheme of things the cons outweigh the pros for me personally.
-Tarek

I have actually run into this at a previous job. We had a similar situation where we would move a piece of equipment from a production area to an R&D area. When needed for production, it would be used there and when it was not in use or scheduled for use, it would be used in the R&D area. This was done for two reasons: to save money (equipment cost) and to allow for development to occur on the same machine as production, in attempt to ease the scale up process. Unfortunately, since the machine was moved from one area to another and parameters were changed and parts were tampered with, the quality team often requires a process validation to ensure that the process and machine are still functioning correctly.

When encountering the movement of equipment in production, I believe that a re-validation is a necessary step. However, as some have mentioned above, it must be identified if a full Validation process is required in order to utilize equipment. This is important because the company needs to ensure that the equipment is still able to produce the consistent product. In my experience, there was a time that a equipment had to be moved 1 foot within the cleanroom due to maintenance requirements and it was a subject that was debated for some time due to the re-validation that would need to occur. So there is not set circumstance that would apply to your need Fady since every situation can differ. Even though a re-validation is a time consuming process at times, it is put in place for maintaining the high quality of the manufactured product.

If the equipment gets moved from one location to another, I do not believe that all processes have to be revalidated. The reason the quality team argued that is because if the equipment was assembled in a different location, this might lead to error due to improper setup or a setup in a completely different environment (percent humidity, temperature, etc.). The most important aspect is making sure the equipment is producing the exact same results in every location and making sure the test method that was developed is being followed appropriately.

Hey,
In my company everytime an equipment that has been validated gets moved to a new room it has to be revalidated IOQ/PQ. Similar to what sns34 said it is due to the conditions of the new location, and anything that could of happened to the machine during the move. It is a very tedious process especially since validation can take days so we just try to get everything in the right room and place before we start running qualified assays.

Moving equipment from one place to another,usually requires revalidation .Revalidation is needed to ensure that changes in the process or in process environment do not adversely effect process characteristics and product quality.when equipment is moved to a new location installation and operation should be re-qualified.By comparing data with original IQ and OQ,the manufacturer can determine whether there have been any change in equipment performance as a result of move.changes in equipment performance should be evaluated to determine when it is necessary to revalidate the process.

Hi, I agree with most of you about the fact that the device needs to be validated again once it's moved because you don't know what could have changed during the process.But depends on the condition, you may not need to do the full validation from scratch. I want to add an FDA reference to this (posted in the other thread as well about re-validation).

Quote from FDA
"The extent of revalidation will depend upon the nature of the changes and how they impact upon different aspects of production that had previously been validated. It may not be necessary to revalidate a process from scratch merely because a given circumstance has changed. However, it is important to carefully assess the nature of the change to determine potential ripple effects and what needs to be considered as part of revalidation"

I have come across this issue with a certain gauge that was applicable to several parts of the production process. The manufacturing department argued that it can just be specified that this gauge has several locations but still performs the same process. However, the production manager said that with each time it moves it should be treated like a separate gauge entirely and be qualified for each of those locations. After much deliberation, it was decided that if it can be qualified to be performing the same exact process no matter where it is placed and produce the same exact result, it would not need to undergo individual IQ/OQ/PQ for every individual location.

It would seem a bit tedious to revalidate the equipment each time it is moved to a different location. However, it would be more beneficial to revalidate the equipment every time. Although the new location may reflect the same environment conditions as the original, the equipment should be revalidated to make sure the same results will be given. When equipment is moved from place to place there are possibilities for damages. Some may not be external damages so the only way to determine there are no issues by revalidating the equipment once it is moved. The safer choice would be to revalidate the equipment every time that the equipment is moved to a different location.

I agree with the post above that it can be tedious and time consuming to re-validate all processes. However, the process is very critical to make sure that the equipment is producing the same results in each location. If the equipment is being assembled in different location then the results can vary due to errors. Instead of re-validating each step, the quality team can identify certain critical steps that are most likely to affect the result. If those results are favorable then not all the steps have to be re-validated. I do not experience in this area but it seems more logical to me.