Revalidation of Process Equipment for Equipment Transfered to New Facility.

#1
Hello All!

We are currently moving some of our exisiting processes to another facility and I have been tasked with determining what the industry best practices are for requalification of production equipment. I have read ISO:13485 and it only states that revalidation will have to be completed if the equipment is moved to another facility. I have read other sources and they state it should be a risk based approach to determine as to what extent an IQ/OQ/PQ needs to be performed. I am curious if anyone could provide some insight with transfering processes to a new facility? Thank you!
 
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somashekar

Staff member
Super Moderator
#2
Hello All!

We are currently moving some of our exisiting processes to another facility and I have been tasked with determining what the industry best practices are for requalification of production equipment. I have read ISO:13485 and it only states that revalidation will have to be completed if the equipment is moved to another facility. I have read other sources and they state it should be a risk based approach to determine as to what extent an IQ/OQ/PQ needs to be performed. I am curious if anyone could provide some insight with transfering processes to a new facility? Thank you!
ISO 13485:2016
7.5.6 f) revalidation, including criteria for revalidation
What does your validation procedure say about this .....
If you have included moving of the process to another facility as a criteria for revalidation, then you have the answer, Please revalidate, ie IQ/OQ/PQ
If your procedure does not state this as a criteria to revalidate, then update your validation procedure, and follow the same., as moving an existing process to another facility is a major trigger to perform the revalidation. You may use all the learnings from the existing validation records to re establish the revalidation, and assure that the process is good and stable as before.
 
#3
Thank you for your answer!

Currently we have no mention of a revalidation procedure in our validation master plan. I have been looking for guidance to establish a revalidation procedure that will be followed once we move processes over to a new location. I was thinking of just having some sort of risk assessment to establish as to what level the revalidation will be performed. Would that be suffcient enough?
 

somashekar

Staff member
Super Moderator
#4
Thank you for your answer!

Currently we have no mention of a revalidation procedure in our validation master plan. I have been looking for guidance to establish a revalidation procedure that will be followed once we move processes over to a new location. I was thinking of just having some sort of risk assessment to establish as to what level the revalidation will be performed. Would that be suffcient enough?
Not the validation master plan ....
The standard asks you to establish documented procedures for validation of processes. If you have 5 processes that are validated, you will have 5 procedures, as the 5 processes would be different in terms of what is said in 7.5.6 a) to g)
You know your processes best, and you will have technical experts as well as competent personnel who are involved in managing your proceses to deliver consistent outputs.
Just to emphazise, a table top process equipment may need to be revalidated if its moved from one table to another. Think about it and discuss with your process managers. Address the criteria for revalidation first in your procedures
 
#5
To my best knowledge, you must first initiate a change proposal listing all equipment, system or Document (ownership/location, if any) being removed and moved to a new facility. Perform the same original procedure to validate the process including IQ/OQ/PQ at the new location, justifying the need for such relocation and establish an objective evidence for each category.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#6
For your own protection a full revalidation is appropriate: IQ, OQ PQ.
for sure IQ as you are hooking it all up to new stuff in a new place.
OQ for equipment parameters for sure - you don't know the effect of the knew place or the move on the equipment.
PQ can probably be concurrent.

The 'risk' with a risk based approach is that most people just guess at the probability that something will go wrong and that is usually biased to the "what can possibly go wrong" side and then catastrophe hits you in the back of the head. IF you look only at the severity of the things that could go wrong (with the assumption that it will) and you only include the high severity items in the validation plan then you could get your plan to a more smaller set of tests. Unless your regulatory reviewer deems otherwise.
 
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