Moving Equipment (Injection Molding Machines) in the Plant - Revalidation Required?

[ATrenz]

Hi folks. I work for an organization that is planning to move several injection molding machines to a different location within the facility.

The guidance documents that I have been able to find regarding process validation, (GHTF Process Validation Guidance is the most comprehensive that I have found) does not clearly define the reval requirements.

It is pretty well left for interpretation of what is required. We have some folks that say just ensure that the installation utilities are the same, basically an IQ. We have others that say, just get it there, and make sure that it still functions per the manufacturer's specifications (a different portion of IQ). We have others that say skip that, and perform an enhanced sampling > 30 pieces to serve as a mini PQ during the first run. Finally, we have some that say "all of the above". The only thing that no one has mentioned is testing the process control limits as you would during OQ.

The guidance that I am referring to reads:

6.4 Examples of reasons for revalidation
Revalidation may be necessary under such conditions as:
· change(s) in the actual process that may affect quality or its validation status
· negative trend(s) in quality indicators
· change(s) in the product design which affects the process
· transfer of processes from one facility to another
· change of the application of the process
The need for revalidation should be evaluated and documented. This evaluation should include
historical results from quality indicators, product changes, process changes, changes in external
requirements (regulations or standards) and other such circumstances.
Revalidation may not be as extensive as the initial validation if the situation does not require that all
aspects of the original validation be repeated. If a new piece of equipment is purchased for a
validated process, obviously the IQ portion of the validation needs to be repeated. However, most of
the OQ aspects are already established."

So, what is the general consensus? I can see an auditor reading the above in any of the fashions that my colleagues have interpreted the guidance. Again, it is a guidance doc, not a requirement.

The FDA guidelines from 1987:

There should be a quality assurance system in place which requires revalidation whenever there are changes in packaging, formulation, equipment, or processes which could impact on product effectiveness or product characteristics, and whenever there are changes in product characteristics. Furthermore, when a change is made in raw material supplier, the manufacturer should consider subtle, potentially adverse differences in the raw material characteristics. A determination of adverse differences in raw material indicates a need to revalidate the process.
One way of detecting the kind of changes that should initiate revalidation is the use of tests and methods of analysis which are capable of measuring characteristics which may vary. Such tests and methods usually yield specific results which go beyond the mere pass/fail basis, thereby detecting variations within product and process specifications and allowing determination of whether a process is slipping out of control.
The quality assurance procedures should establish the circumstances under which revalidation is required. These may be based upon equipment, process, and product performance observed during the initial validation challenge studies. It is desirable to designate individuals who have the responsibility to review product, process, equipment and personnel changes to determine if and when evalidation is warranted.
*************************Original Page 13********************
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.


Soooooo, any thoughts on what is required for us to perform? It is all up to interpretation, and the auditor's mood in my eyes.

Thanks so much in advance!
Adam

[Ajit Basrur]

Welcome to the Cove

We typically do a abbreviated requalification covering -

1. IQ for connecting the Utilities and some disassembly of machine,

2. OQ for verifying the functioning of the Utilties, check some important Injection Molding machine parameters and

3. PQ by running a previosuly validated process parameters for a part to demonstrate that the IMM functions properly.

[MIREGMGR]

Our approach is similar to Ajit's. The guidance only requires a full reval if the equipment or process has changed...so we do a mini-val to determine if change has occurred. If not, we do a memo to file to document the sequence of events.

I don't think the exact steps you take in your mini-val are critically important as long as your file includes a comprehensive justification for their combined effectiveness at detecting whatever changes might have occurred in your circumstances.

[ATrenz]

Thanks folks. I agree with verifying the utilities are present and per the manufacturer's specifications upon re-install at the new location. I also agree with ensuring that the critical process parameters still function per the manufacturer's specifications to ensure that any unseen damage has not occurred during relocation. These in my eyes are two points that we cannot overlook or assume is okay.

One can argue that your process inputs are the same, and that the outputs will be the same as they were before. But, then I swing back to the definition of process validation, and then I agree that based upon the definition that is universal to all standards and guidance documentation that objective evidence is required.

"Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined requirements."

Therefore, I will suggest the following:

IQ, verify utilities are per manufacturer's specifications

equipment OQ, verify that critical process parameters function pert he manufacturer's specifications (this should be aligned with the original acceptance criteria of the validation at the previous location)

Process OQ, no need assuming successful abridged PQ.

Mini-PQ, subgroups totaling to no less than 30, with good process capability indices and display of process control. I would expect this to be quite comparable to the ongoing capability collected from production runs. I would hate to say that it "must be equal to or greater than" as I could really tie my hands with that statement in a protocol.

I would hate to call it IQOQPQ, but will title the documents "equipment relocation validation" protocol or report respectively.

Anyone see any flaws with this approach?

Additionally, for argumentative sake of the colleagues that are bound to push back and say that this approach is too time consuming, and is overkill...., what MUST be performed, and per what requirements/guidance/regulation...is there anything particular that I could cite?

It all seems common sense to me, "what changed, what is the impact, is everything still ok? Prove it!, Oh yeah, document it too!!!!"

Thanks again!

[gholland]

We just moved our machinery in our building due to renovation... our process was:

- IQ for everything, some items could be abbreviated (no need to ensure all the paperwork/training is in place for example) but the requirements of the machine and the surrounding environment must be considered.
- OQ only for machinery that was disassembled
- PQ for everything

The thought being that you must prove that the facility location you have selected meets the requirements of the process (IQ). If the inputs to the process haven't changed you can skip OQ, otherwise if you have disassembled the machinery you may have affected the machine and therefore some settings may not be valid (OQ). We then ensured that moving the machine did not affect the ability of the process to produce product to the requirements (PQ).

I don't know how you would talk your way around doing at least an abbrevieated IQ and PQ for a piece of equipment that has been validated and then moved.