Hi Guys,
Please, Can you give me your suggestion about this query?
I have to qualificate a series of machines (or equipment) of a line of production. The equipment are for example, mocrofilter A + tank C + microfilter D + tank E.
Can I consider these series of machines a subsystem?
In this case, the qualification approach is: IQ+OQ+PQ of the subsystem, it means all the machines together. Is it correct for you?
In alternative, must I consider each single machine to qualificate?
In this case, the qualification approach is IQ+OQ+PQ of single equipment.
How do you execute the PQ for both of them approach?
Moreover, what is the difference of “train of machines or equipment” and “subsystem”?
[quote=egizzi]Hi Guys,
Please, Can you give me your suggestion about this query?
I have to qualificate a series of machines (or equipment) of a line of production. The equipment are for example, mocrofilter A + tank C + microfilter D + tank E.
Can I consider these series of machines a subsystem?
In this case, the qualification approach is: IQ+OQ+PQ of the subsystem, it means all the machines together. Is it correct for you?
In alternative, must I consider each single machine to qualificate?
In this case, the qualification approach is IQ+OQ+PQ of single equipment.
How do you execute the PQ for both of them approach?
Moreover, what is the difference of “train of machines or equipment” and “subsystem”?
Thank you in advance,
E[/quote]
Each critical piece of equipment in the line has to be qualified. Whether you choice to do it as individual protocols or one protocol group it is up to your VMP/SOPs.
Thank you very much Seal
anyway, as I am understanding what you have just said in Quality Assurance, it is possible to use a single protocol for single machine or one protocol group for a series of different machines.
If I chose to make a protocol group, what is your opinion about the qualification approach on performance qualification?
I explain, I can make IQ and OQ test dedicated to each single machine, about PQ can I include all the machines together in a single performance qualification?
[quote=egizzi]Thank you very much Seal
anyway, as I am understanding what you have just said in Quality Assurance, it is possible to use a single protocol for single machine or one protocol group for a series of different machines.
If I chose to make a protocol group, what is your opinion about the qualification approach on performance qualification?
I explain, I can make IQ and OQ test dedicated to each single machine, about PQ can I include all the machines together in a single performance qualification?
thank you in advance
E[/quote]
The PQ can be done as a single protocol for all equipment or you can group it into one protocol. When I group the PQ for equipment what I like to do is work with planning and see if I can get the same product to run over the course of the PQ and then I can qualify the product (process) as well. So the protocol would be a pq/ppq and I would state that sampling should be performed after each critical equipment and set acceptance criteria. Then I do finish product sampling at the end of the line as well.
[quote=seal]The PQ can be done as a single protocol for all equipment or you can group it into one protocol. When I group the PQ for equipment what I like to do is work with planning and see if I can get the same product to run over the course of the PQ and then I can qualify the product (process) as well. So the protocol would be a pq/ppq and I would state that sampling should be performed after each critical equipment and set acceptance criteria. Then I do finish product sampling at the end of the line as well.
I hope that helps.[/quote]
Dear Seal,
thank you for your quckly reply
on reading your reply you are saing that the PQ have to be made by the running of the lots (I imagine to run the commercial standard lots, number 3 lots). At the same time you have used the terms PQ or PPQ on approaching the performance, but my question is, this qualification is a PQ (performance qualification) or not?
If you use PPQ (process performace qualification), it sounds like a “proces validadion” and not performance qualification …
[quote=egizzi]Dear Seal,
thank you for your quckly reply
on reading your reply you are saing that the PQ have to be made by the running of the lots (I imagine to run the commercial standard lots, number 3 lots). At the same time you have used the terms PQ or PPQ on approaching the performance, but my question is, this qualification is a PQ (performance qualification) or not?
If you use PPQ (process performace qualification), it sounds like a “proces validadion” and not performance qualification …
can you explain this, please ?
thanks a lot[/quote]
The PQ is a test under load conditions. This is new equipment so therefore you would need to PQ all the equipment. What I am saying is take it a step further and “kill two birds with one stone”. You are going to have to do a process validation on the products as well so I would save the time/effort/money/etc and try to combine the activity of the PQ with the PPQ.