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GMP license

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Guest user Created:   Sep 08, 2021 Last commented:   Sep 10, 2021

GMP license

My company doesn’t require this, but I’m trying to understand the difference between being ISO 17025 certified versus having a drug establishment license from Health Canada and letter of Compliance from the FDA.  A third part lab we use does not have ISO 17025  but does have the other 2 items mentioned, they are an approved lab for Pharmaceutical testing and we manufacture for both Pharmaceutical companies and Dietary companies.  Is there anything outside the requirements for a GMP license by Health Canada that ISO 17025 has that would impact the validity of the test results from a lab that doesn’t have ISO 17025.  It is also not a requirement to have ISO 17025 but there can be an equivalent license.  Would the Health Canada license be considered equivalent?

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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Sep 10, 2021

There are differences in requirements for ISO 17025 accreditation and GMP certification. It is outside of the scope of the ISO 17025 Academy to comment on regulatory requirements, for example that of Health Canada. I suggest you contact the regulatory body.

For more information on ISO 17025, have a look at What is ISO 17025 at

https://advisera.com/17025academy/what-is-iso-17025/

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Sep 08, 2021

Sep 10, 2021