Hi Guys,
Can someone help me with the following query:
I have 2 new medical device packaging machines that will be validated soon. If both machines will run the same materials, the same products at the same parameters do we have to PQ both machines. Products from both machines will be subjected to burst, pull and dye test. If we run a lot of 2500 sealed kits on each machine what is the minimum number of samples I should submit for AA studies.
Cheers
Regarding the question of whether you should run PQ on both, I would say yes. Machines are machines and IQ/OQ can only tell you so much. I would think you could do a limited PQ on the second machine; i.e., reduced number of runs, reduced parameter set ranges, etc. Document the rationale for any such reduction, of course.
This is a recurring issue. in my opinion based on our corporate guideline, you Should:
1 - Perform a risk analysis to assess whether the reduction of lot size does not affect the process.
2 - If it was not affected, divide the lot 50% and 50%, then a defined AQL and inspection level ANSI calculated by taking the sample for each sublot (which will differ from the total sum for sure), having defined the critical defects, major and minor.
3 - It would take the machine to the status of “worst case” (eg maximum speed) and run the PQ with the sampling plan specified in paragraph 2.
I hope this helps and if you need help you can tell me to write it.
Thanks guys for the reply, ISOPHAR can you explain point two a little better for me.
Regards