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.

 

[Melissa]

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

What about if you are looking for the speeds on the settings on a pouched product. How would you go about that?

 

[LUFAN]

What about if you are looking for the speeds on the settings on a pouched product. How would you go about that?

Your OQ might make X number of parts on the fastest, slowest, and middle speed settings and confirm that regardless of the speed, the verification activities performed on each of the speeds produced results materially similar (within defined tolerance) to each other.

 

[Ajit Basrur]

What about if you are looking for the speeds on the settings on a pouched product. How would you go about that?

If you are referring to the heat sealing process there are typically three important parameters, namely, sealing temperature, contact pressure, and sealing time/speed (dwell). The contact pressure and dwell are generally set by the equipment manufacturer, and the user responsible for establishing the sealing temperature.

In OQ, sealing samples must be produced at the respective lower and upper limits and checked for the quality attributes as listed in ISO 11607- 2 standard. Typically, intact seal for a specified seal width, no channels or open seals, no punctures or tears , and no material delamination or separation.

The ISO 11607 standard series is a great resource

ISO - ISO 11607-1:2019 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems

ISO - ISO 11607-2:2019 - Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes