Questions regarding process validation

[duff999]

Can anyone help me at a very high level what is meant by this flowchart with regards to process validation.

What is meant by "is Process Output Verifiable" I am trying to understand my trigger to perfrom IQ, OQ, PQ but cant wrap my head around what would be a "Yes"

 

[shimonv]

The phrase "Is the process output verifiable?" means can you be assured that the tasks were completed successfully without altering, damaging or or destroying the product. Some task can be 100% verifiable by visual inspection, measurements or some kind of jig or software tool.
Some tasks like sterilization, soldering, or sealing a pouch cannot be verified without damaging the product. For these you need process validation.

Shimon

 

[duff999]

Thanks for the information Shimon. If we perform a QC check for every product at various stages throughout the process and all checks pass, is process validation required.

 

[shimonv]

If you can show that every requirements is met in every unit you produce then you don't need a process validation.

Shimon

 

[Ajit Basrur]

Thanks for the information Shimon. If we perform a QC check for every product at various stages throughout the process and all checks pass, is process validation required.

Remember that the QC check is a "sample" and not "100% verifiable". As Shimon explained earlier, if you can not demonstrate 100% verification, the validation is required.

 

[duff999]

Another quick question. Would a certificate of analysis, or certificate of conformance serve as verification?

 

[chris1price]

Almost certainly not, unless the CoA specifically referenced every individual product and covered every step in the process.

Also, don't forget that testing itself is a process, so your test method needs to be validated.