A common question we often get is: How many runs do I have to produce for a Performance Qualification (PQ)?
As always, check the regulations & standards first.
ISO 11607-2 mentions that you have to do at least 3 production runs to assess variability within a run and reproducibility between different runs.
So, does that mean you only have to do 3 production runs?
No, unfortunately not!
The number of PQ batches needs to be justified based on different sources for variation. The batch must be representative for a routine production.
Do you have any further questions on how to do Performance Qualification (PQ) in medical device production?
Let us know in the comments! 👇
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Medical Device Consulting
Quality Management
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Installation Qualification (IQ)
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