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Is ISO 17025 required for a third party lab that is FDA and Health Canada Licensed?

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Guest Created:   Aug 30, 2021 Last commented:   Sep 01, 2021

Is ISO 17025 required for a third party lab that is FDA and Health Canada Licensed?

During a GMP audit, it was noted as a non-conformance that the third party lab (used for testing of raw materials and finished excipient products) did not have ISO 17025 accreditation.  The lab is licensed by Health Canada and the FDA through on site inspections and the license indicates that chemical and microbiogical testing is authorized.  Is licensing through the government bodies sufficient for testing on its own or is the lab required to have ISO 17025 certification as well?

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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Sep 01, 2021

If compliance to GMP requires that the third party testing laboratory is ISO 17025 accredited, that is a mandatory requirement that must be met, irrespective of any other professional registration or certification.

See the article, Six key benefits of ISO 17025 implementation, for general information at

https://advisera.com/17025academy/blog/2019/10/18/six-key-benefits-of-iso-17025-implementation/

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