1)in order to define the applicability of qualification to equipments, do you group or categorize the equipments? if yes, what is the general suggested practice?
2)similarly, do you define the examples of scenario which does not trigger re qualification, if yes, what is general suggested practice. (viz., situations, where calibration is adequate, vs where re-qualification is required)
do we define any criteria for “of the shelf”(viscometer, pH) kind of used equipment vs. semi-configured equipment.(hplcs, dissolution etc.,which consists of multiple&optional components and are virtually assembled during installation)
Normally there are three categories, GMP-Critical, GMP-Noncritical, and Non-GMP. Qualification mainly applies to Critical and non-critical. Keep in mind that is up to the overall quality strategy how you treat Non-Critical equipment. Additionally there are levels of customizations that are use to define the level of qualification/validation activities. Usually there are 3 categories at the equipment level and 5 at the computer system level. Examples are 1. off the shelf (equipment you buy, plug it and start using it), configurable (only parameters have to be set), and customized (completely designed and customized for one application). These three examples are applicable to equipment and computer related systems. Qualification activities depend on the company approach. You can use ASTM E2500 and GAMP 5 to expand you understanding on this approach.
the company I work for is bound to EU GMP. In these GMP’s it is stated that re-qualification should be done when making changes to the system. There is no other mentioning of separate requalification.
so what we did is, as soon as an equipment didn’t have any changes for a certain amount of time (e.g. 5y) then an assessment will be made.
But I see you are more talking about analytical equipment.
Once IQ and OQ or done on such equipment you do not redo them as long as you do not make any changes to the system.
Your routine calibration or system suitability testing should cover the aspect of re-qualification. Your maintenance (service level or own maintenance) should provide full detail on what they did so you can estimate the impact and the need of re-qualification. Most of the times the supplier knows in what cases of maintenance a (partial) re-qualification is needed.
best wishes for 2014
I presume you are talking about moving equipment to other places.
Depending on the equipment and the degree of disassembling and re-assembling you need to do requalification as well.
for instrument it can be that you just recalibrate.
For whole machines that need to be disassembled and re-assembled it might even be a hole IQ/OQ again.
So not easy to say. Just think logically. What can go wrong and would have impact on the good fonctioning (quality) of the equipment when you will move it to another place.
Use that as start point and you’re haflway your risk assessment which can help you identify the things to retest/requalify.
So no straightforward answer as all depends on the systems complexity.
For relocation perform a risk assessment of what can go wrong and emphasize the -revalidation to high risk areas. Low risk areas may not be re-validated.
If you didn´t make changes in equipment, you don´t have redo IQ/OQ, haven´t you? What kind of assessment you do at 5y? How do you document this? What if any changes were made but the change control system failed? Is the requalification the opportunity to detect these little changes that weren´t documented? So, we have to do IQ/OQ again anyway… because is the best way to detect if equipment is “the same” as original qualification… I’m right?
your question is quite complex and touches different quality systems. I will approach them question bu question,:
Moving Equipment
If no changes are made to the equipment when it is being moved then in theory one should not do anything. Yet equipment can be complex. Based on the extent of disassembly and reassembly errors can be made.
So a risk based approach is required in which you state what is pulled out and dismantled, and then it will become more clear what you have to test. Compare it to moving your microwave from the kitchen to the garage , or have your kitchen completely moved. (appliances, sink, water, hood,…) you see what I mean?
Microwave is like plug and play cause nothing is touched and all can be moved as one thing. A kitchen is far more complex to move.
Requalification :
I did not say anywhere if it has to be 5 years, this is company policy and should be aligned with auditors and take into account the kind of systems you have.
Different companies, different approaches cause the APR might cover a part of it. At least one should assess following things
[LIST=1]
review of maintenance log (preventive and incidental)
review of calibration of its instruments
review of changes (and documentation --> validation , maintenance log or equipment log)
review of changed GMP's that might affect the system
for system that perform critical processes as sterilising , take into account the revalidation result. Normally there is always a loop between bad validation results, changes and requalification of the equipment.
I think with this you can make the conclusion whether the system is A) still fit for use B) still in a qualified state.
The other two questions are covered by what I wrote above. We are still humans and sometimes due to time pressure things do not get noted down while they have been done. But for the auditor’s point of view : if it is not documented it is not done. I know it is sad that we have evolved to having a small paper saying whether it is done or not. But there is a reason for it. Especially when patient’s safety is at risk.
So in this case it is not 100% sure that a periodic review will catch all not documented changes. Normally along the proces of maintenance somewhere there should be a document saying that something has been done to a system. But even that can be forgotten. If you want to be sure you need to do a complete requalificcation.
But if your change control is failing , and not because of time pressure or lack of resources, then first of all; you should tackle this point, because change control is the driving force to have changes implemented in a controlled way.
All your answers were so clear! And very useful too. I’m in time for equipment requalification (our plant is so young!) and this opinions are a great help. Thanks again for taking time answering me!
no problems… we are there for sharnig knowledge.
Concerning my last post. I always re-read a bit later to see whether I don’t make too many errors when trying to write things in a more condensed way.
So for the moving of equipment. Most of the times there are basic tests to see basic operations still function. Like for motors testing the direction (especially when you have 3 phase power supply.
But this should normally come out of the risk assessment. When doing this assessment also focus on the critical, vulnerable and other mechanical parts of the system that can sustain damage during the move.
With the quote “So in this case it is not 100% sure that a periodic review will catch all not documented changes. Normally along the proces of maintenance somewhere there should be a document saying that something has been done to a system. But even that can be forgotten. If you want to be sure you need to do a complete requalificcation.” I mean,
If you have an electronic system in maintenance which issues the work orders for maintenance, then normally incidental interventions should also be reported in this system (if not forgotten by the responsible person. And with the complete requalification I mean that if you are not able to depend on the information of your supporting quality systems, then instead of doing an assessment you always can do a complete requalification of teh system (time, cost… ) don’t forget to tae into account any changes in the regulatory rules…
My first case is an autoclave. And the questions were about the IQ. In the initial qualification the whole plant were in construction, so was easy to do the IQ as the same time it was assembly. But now some parts are difficult to see, so I have to do an analysis about what parts I can to inspect. Some changes were documented in Maintenance System and Equipment log, but I have to inspect to be sure that these are ALL the changes…
I’ll be in contact with you if there is any another question! You are very clear to explain!