Hi all,
I am currently qualifying a new packaging system.
The client would like to execute the PQ with commercial lots of a product.
But I believe that falls under the process validation and they are mixing two distinct processes.
I thought that the PQ was just testing the equipment under normal operation (speed, packaging material, temperature, etc.) for a representative amount of time or units.
And this to allow the proper examination of defects, printed parameters, etc…
In addition, packaging a commercial product with an equipment which is not completely qualified/validated is not advisable.
I was just wondering if someone has any advice on the topic.
To me the PQ should represent a good proportion of a routine lot (maybe more than 50%) to cover all issues, personnel changes, material changes with a placebo.
If this is conclusive and thus closing the qualification of the equipment than a routine lot can be performed on a commercial product.
Thank you for all comments and help.
Have a good day…
[quote=toneb021]Hi all,
I am currently qualifying a new packaging system.
The client would like to execute the PQ with commercial lots of a product.
But I believe that falls under the process validation and they are mixing two distinct processes.
I thought that the PQ was just testing the equipment under normal operation (speed, packaging material, temperature, etc.) for a representative amount of time or units.
And this to allow the proper examination of defects, printed parameters, etc…
In addition, packaging a commercial product with an equipment which is not completely qualified/validated is not advisable.
I was just wondering if someone has any advice on the topic.
To me the PQ should represent a good proportion of a routine lot (maybe more than 50%) to cover all issues, personnel changes, material changes with a placebo.
If this is conclusive and thus closing the qualification of the equipment than a routine lot can be performed on a commercial product.
Thank you for all comments and help.
Have a good day…[/quote]
You can packaged product and perform a PQ at the same time. The lot the should put on hold until the PQ is approved. The difference between the PQ and PPQ is that the PQ looks at each piece of equipment while the ppq looks at the process as a whole (we look at finished results not so much the results at each step). I like to run my PQ under normal conditions that is if I know the equipment is going to run 100,000 bottles every run I would use 100k bottles.
It depends on the company’s policy (budget constraints as well) and comfort with the level of risk whether or not they want to use live product for PQ’s or placebo.
But if you use products for the PQ, would you perform 100% inspection or still keep using AQL?
Does it come down to the decision of the client to risk a commercial lot failure?
It’s not risky to manufacture a commercial product with an equipment which not completely validated and to defend it in front of regulatory bodies?
Thanks again for your inputs.[/quote]
100% inspection is too labor intensive in my opinion. However, it depends on the risk levels involved as well. Typically I would just increase the AQL from normal sampling to tighten and use that sampling to assure a high level of confidence. Also, if the test is destructive a different sampling plan would need to be evaluated.
During my past life I have used commercial product for the PQ in OTC products and have had the whole validation process review and they (FDA) had no negative comments (no 483s) with the methodology and justification.
[quote=seal]100% inspection is too labor intensive in my opinion. However, it depends on the risk levels involved as well. Typically I would just increase the AQL from normal sampling to tighten and use that sampling to assure a high level of confidence. Also, if the test is destructive a different sampling plan would need to be evaluated.
During my past life I have used commercial product for the PQ in OTC products and have had the whole validation process review and they (FDA) had no negative comments (no 483s) with the methodology and justification.[/quote]
I did not know it was possible…
Thanks again for your help!
