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Can contract manufacturer exclude validation from their scope?

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Guest user Created:   Sep 24, 2020 Last commented:   Sep 28, 2020

Can contract manufacturer exclude validation from their scope?

I just want to know if it is possible that a contract manufacturer can exclude validation from their scope?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Sep 25, 2020

Validation must be provided for all processes where the resulting output cannot be or is not verified by subsequent monitoring or measurement. Validation can be excluded from the scope, but not from the processes. However, if it is your contract manufacturing, you are responsible for validation of that process so the validation process can be under your jurisdiction. 

For more information, please see the following articles:

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Guest user Sep 25, 2020

This answer/blog is for process/manufacturing.  Can they take exclusion to section 7.3.7  Design and development validation?  If it is not included here then how is this done?

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Expert
Kristina Zvonar Brkić Sep 28, 2020

No, exclusion 7.3.7 Design and development validation is not possible since it is a strict requirement from the standard. They have to have documented validation plans and all other arrangments. However, this can be outsourced to some other company or laboratory, but then this should be explained as such.

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Sep 24, 2020

Sep 28, 2020