Packaging validation / qualification report for medical devices - Example wanted

[Azu2008]

Hello I need your help: Does anyone have a model of rapport of packaging validation/qualification for medical devices?

[Marc]

What packaging specification does the packaging have to meet?

Any ideas, folks?

[Adarsh]

Hello,

Are you looking for examples of specific Packaging equipment qualification like Pouch Sealers, and Tray Sealers?

Thanks,
Adarsh.

[santhosh741]

Company Profile on Process Validation and Control

• You are to choose a product within your company location and:
  • conduct an in-depth study of the product from its design elements through the development and execution of process validation and the subsequent monitoring of the key process and product design output controls
  • analyze and discuss the various controls from components through release and stability
    • your opinion of their adequacy
    • recommendations if appropriate

[dcraig]

As far process validation attached is the GHTF Guidence Document. It discusses IQ/OQ/PQ. This is a good starting point. You have to figure out the critical parameters for what ever type of packaing you are doing for OQ then those are the parameters along with material which must be controlled later. You must also determine how to qualify the package ISO 11607 is good source for this if it is sterile. Hope this helps get you started.

[MIREGMGR]

In Reply to Parent Post by Azu2008

(...) Does anyone have a model of rapport of packaging validation/qualification for medical devices?

I take that to be a request for an ISO 11607 validation/compliance report...not just a production-process validation report.

I can't help out because that info is highly proprietary for us. It's taken us over a year of constant work for two engineers, and a ton of money to a testing-services/consulting firm that has two principals heavily involved in 11607 development, and a separate Ph.D. consultant on our end, to get a handle on how to do it right. Our understanding from our consultants is that doing it right is rare at this point...and a lot of that would be learnable from our documentation.

Anyway, that's what I think is being asked for.

[dcraig]

I agree that is what the poster is asking for. I also agree it is information that is not likely to be given away due to its proprietery nature. I attampted to direct him to the source information as a starting point.