Questions regarding process validation

duff999

Involved In Discussions
#1
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"

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shimonv

Trusted Information Resource
#2
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

Involved In Discussions
#3
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.
 

Ajit Basrur

Staff member
Admin
#5
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.
 

chris1price

Trusted Information Resource
#7
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

Starting to get Involved
#8
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

Involved In Discussions
#9
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

Staff member
Admin
#10
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
 
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