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Gxp versus 13485

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Guest user Created:   Nov 10, 2022 Last commented:   Nov 10, 2022

Gxp versus 13485

I am working an a pharma company with haveing a some combination products - medical device with pharma. We want to have in addition to GxP System the 13485.
Could we implent the 13485 with a mixture of good running GxP SOP (e.g. change control) and new ISO SOP?s

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Kristina Zvonar Brkić Nov 10, 2022

Yes of course that you can.

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Nov 10, 2022

Nov 10, 2022

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