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.
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ISO 17025 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 17025 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
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:
- Six key benefits of ISO 17025 implementation at https://advisera.com/17025academy/blog/2019/10/18/six-key-benefits-of-iso-17025-implementation/
- What is ISO 17025? at https://advisera.com/17025academy/what-is-iso-17025/
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/
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Jul 30, 2020