Performance Qualification and Process Validation

Schkund

Involved In Discussions
#1
Are these two different things or are they different ways of defining a very similar task (with process validation having a larger overall scope)? I work for a contract manufacturer and when we develop a process for new products, we will work with the customer to validate the production process to their requirements. Is a performance qualification in any way different from this activity? I know a process validation could potentially involve several lines of production whereas performance qualification tends to be associated with one specific piece of equipment, but other than that I am at a bit of a loss and I'm not sure what activities would need to be performed in a performance qualification that aren't addressed as part of our equipment IQ/OQ or process validation.
 
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Tidge

Trusted Information Resource
#2
Caveat: Performance Qualification means different things to the medical device and pharmaceutical industries. There is also a layer of confusion introduced when non-product software validations use the term... a common approach is GAMP 5 which came from Pharma.

In all of the cases I mentioned above, Performance Qualification is one activity in a greater Validation (including "Process Validation").

EDIT: For medical devices, Performance Qualification is pretty much "examination of outputs when the process is run at nominal settings, with natural variability coming from operators and raw materials". The examination should be aligning with the control plans for the process during PQ.
 

Schkund

Involved In Discussions
#3
To clarify, our facility does not operate in the pharmaceutical industry, only the medical device industry.

So would the activities that we are performing as part of our Process Validation be considered the Performance Qualification? (Specifically, the activities taken to ensure that we are able to consistently make parts that meet requirements.) I have suspected that this is the case, but could never find a clear answer.
 

Tidge

Trusted Information Resource
#4
Process Validation in the medical device industry typically consists of
  • IQ - focused on equipment
  • OQ - focused on allowed variation
  • PQ - focused on inherent variation around nominal
The classic GHTF documents are the best starting point.
 

Schkund

Involved In Discussions
#6
Thank you, Tidge, I think I understand better now. The definitions provided in the GHTF document are especially helpful.
 
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