Performance Qualification per GHTF Guidance

DamienL

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#1
Hi, I'm trying to develop a Process Validation SOP for a Medical Device startup based on the GHTF guidance. My last experience with Process Validation goes back quite a while and is probably way out of date. It was with a multi-national who qualified the output of each sub-assembly process individually (what they referred to as PQ/Process Qualification); then additionally qualified the output of the overall manufacturing line (what they called PPQ/Process Performance Qualification). PQ was usually verified against specifications on the sub-assembly drawing. PPQ on the other hand typically verififed against finished device specifications and done on sterilized devices. Both usually involved 3 batches run on different shifts, different operators, different raw material batches, etc.

My question is what is typically done for PQ/Performance Qualification described in the GHTF guidance? I get the bit on Operational Qualification, but am confused about the subsequent elements of PV. From reading up on it, consensus seems to be that even if all processes are 100% verified (i.e. no validation needed for the individual processes), that you would still need to validate the overall manufacturing line. So even though the terminology has changed, I'm wondering if current practice is still what I described above - i.e., if you can't verify the output of an individual process, then validate those processes, and additionally qualify product that has been through the entire manufacturing line, including sterilisation, against finished device specfications (what I've called PPQ above). It looks to me like you need to do both of these in order to satisfy the requirement for Performance Qualification. Can anyone put me straight on this? Thanks
 
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indubioush

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#2
It seems that everyone does process validation a little bit different. However, if all your processes on your manufacturing line are able to be verified, and verification alone is sufficient in terms of risk and cost, then you would not have to do process validation of that manufacturing line. Of course you would have to document this decision, but you would not have to do PV.
 

DamienL

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#3
OK, so you're saying that if the output of all your processes are verified, then no need to do any OQ/PQ activities. I like the sounds of that, it suits my end goal here, although I've come across a few articles suggesting that (with FDA anyway) you would still need to validate the overall manufacturing process.

Anyway, the more usual situation for our company will be that we won't be able to verify the output from all our processes. So I'm wondering what standard practice is in these situations? Do you validate the output of the individual processes AND ALSO validate that product which has been through the entire process meets finished device specifications (what I used to call PPQ)? I'm really unclear as to what is typically done during Performance Qualification - is it just qualifying the individual processes vs sub-assembly specifications, or does it involve qualifying that product which has seen the full manufacturing process meets finished device spec's? Or maybe both?
 

indubioush

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#4
If your finished device is able to be 100% verified that it meets finished device specifications, you would not be required to validate that process. This does not apply to you though. Usually, it is best to focus on each process. If you have a subassembly that is a result of three different processes, you may need to validate each one, and you may need to validate them in a certain order. You don't want to be in a situation where you are doing one test to validate multiple special processes.
 

indubioush

Quite Involved in Discussions
#5
although I've come across a few articles suggesting that (with FDA anyway) you would still need to validate the overall manufacturing process.
Can you tell me which articles these are? If I was manufacturing a device that was able to be 100% verified, I would still have a master validation plan that provided justification for each process that did not require validation. I will still perform IQ and possibly OQ for equipment if needed.
 

DamienL

Involved In Discussions
#6
Can you tell me which articles these are? If I was manufacturing a device that was able to be 100% verified, I would still have a master validation plan that provided justification for each process that did not require validation. I will still perform IQ and possibly OQ for equipment if needed.
As I'm new to the Cove, I can't post links, but if you google "Jeff Boatman a comparison of process validation standards" you should be able to find a PDF. In section on "Validation Of Overall Process" he seems to be saying that the overall manufacturing process always needs validation, irrespecive of the ability to verify individual processes or the final finished product. Would you agree with him on this?

Anyway, in my case validation is needed as we won't be able to 100% verify the output of either the individual sub-assy processes or the overall process (because of tensile and some other requirements). For this sort of situation, he then goes on to say that a combined "PQ/PPQ strategy of performing PQ on individual processes and then an overall PPQ to make actual finished product may well be a waste of time and effort". So I'm struggling with this last bit the most. Maybe a simplified version of my scenario will help get my question across clearer:

We will have a number of bonding processes at the sub-assembly level. The sub-assy specifications will have tensile requirements written on them so that we have something to validate against. The finished device specification will also have analogous tensile requirements, although they may be offset to account for impact of sterilisation and other processes encountered along the way.

So my past experiences would have us OQ'ing and then PQ'ing the individual bonding sub-assy processes. We would also be doing a separate protocol (which I used to call PPQ), which would be qualifying that product which has seen the full manufacturing process incl. sterilisation meets the finished device tensile specs:
- OQ individual sub-assy processes (against sub-assy tensile specfications)
- PQ individual sub-assy processes (against sub-assy tensile specfications)
- PQ full line (against finished device tensile specifications)

But based on this article, I'm wondering if I should be doing something like the following:
- Have no sub-assy tensile specifications, just finished device specifications
- OQ individual sub-assy processes against finished device tensile specfications (may require the OQ units to be fully assembled)
- Skip PQ of the indivivual bonding processes (becasue this article suggests a waste of effort if you have to PQ the full line anyway)
- PQ full line (against finished device tensile specifications) and use this to say that the overall process is validated

Any thoughts on this or a different approach?
 

TWA - not the airline

Trusted Information Resource
#7
I also have seen different approaches to process validation throughout my career. I'm still not sure if that is because products and companies differ in ways that inevitably lead to these differences or rather come from different philosophies or different understanding of the topic and the requirements.
From my experience FDA is typically happy if the SOP for process validation is based on the GHTF document. But, based on the preamble to the CFR820, they also expect some kind of qualification and control for all processes and tell manufacturers to not solely rely on 100% inspection. However this does not mean validation; an OQ that determined the correct nominal settings and defined the necessary maintenance of the equipment etc. might suffice.
What I'm struggling with right now is, that the example is a bonding process with specs for tensile strength. This would in my understanding always be a special process needing validation as I cannot think of any reasonable 100% inspection. A proof test might show that a particular device passes the spec without being destroyed, but as you would not notice any trends towards lower strengths in the process, your control over the process would be very weak...
 

DamienL

Involved In Discussions
#8
Thanks very much TWA. For the example given I'm not trying to suggest getting out of PQ. My question is about how much validating I should do at the individual sub-assy process level versus on the finished device - ie. option A or option B below? Or maybe some other approach?

OPTION A
- Create a sub-assy tensile specfication to validate against
- OQ individual sub-assy processes (against sub-assy tensile specfications)
- PQ individual sub-assy processes (against sub-assy tensile specfications)
- PQ full line (against finished device tensile specifications)

OPTION B
- Have no sub-assy tensile specifications, just finished device tensile specifications
- OQ individual sub-assy processes against finished device tensile specfications (may require the OQ units to be fully assembled)
- Skip PQ of the indivivual bonding processes (becasue this article suggests a waste of effort if you have to PQ the full line anyway)
- PQ full line (against finished device tensile specifications) and use this to say that the overall process is validated
 

pziemlewicz

Involved In Discussions
#9
Anyway, the more usual situation for our company will be that we won't be able to verify the output from all our processes.
"Special Processes" cannot be verified and must be validated:
  • sterilization
  • clean room
  • heat treat
  • plating
  • injection molding
GHTF gives a list on pg 7, or you can look at the things NADCAP certifies.
 

DamienL

Involved In Discussions
#10
Thanks. I'm not trying to get out of doing a Valildation, I understand the need for it in this case. My question is more about the specfiics of what the PQ portion of that validation should look like - option A or B above or something else altogether?
 
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