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Applicability of 17025 to GMP analytical laboratory

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Guest user Created:   Jul 29, 2020 Last commented:   Jul 30, 2020

Applicability of 17025 to GMP analytical laboratory

The question is about the applicability of 17025 to our operations. We are a GMP analytical laboratory that conducts lot release testing for pharmaceutical and/or biological products used in clinical trials and eventually for commercial.  We abide by 21CFR11.  

We only test these medicines. We do not manufacture. 

Does ISO 17025 apply to our operations?

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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 Jul 30, 2020

Yes, ISO 17025 is definitely applicable for your laboratory. Both the laboratory and customers will benefit from the assurance of technical competency. The context for your laboratory it seems from your question, is that there are other interested parties and certifications involved. They could in fact require your testing laboratory to be ISO 17025 accredited.

The following articles may be of interest:

Also have a look at the 17025 Expert Advice Community topic ISO 17025 for internal quality control laboratory at https://community.advisera.com/topic/iso-17025-for-internal-quality-control-laboratory/
and the free demo of the ISO 17025 Documentation Toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/ to provide further support

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Jul 29, 2020

Jul 30, 2020