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ISO 17025 in pharmaceutical industry

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Guest user Created:   Aug 31, 2020 Last commented:   Oct 17, 2022

ISO 17025 in pharmaceutical industry

I would like a brief overview of the linkage of ISO 17025 and GMP
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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 02, 2020

While ISO 17025 is an international standard to ensure the consistent and competent performance of testing and calibration laboratories; Good manufacturing practice (GMP) is a an internationally recognised system specifying the minimum standard to ensure that products are produced and controlled consistently to meet a number of quality requirements.

GMP compliance is mandatory, being legislated and enforced at a national level.  This means that countries could have variations (versions) of GMP. Exporting of products will dictate whether for example, the GMP must meet FDA GMP standards. ISO 17025 per se, is a standard adopted voluntarily by most laboratories. In certain sectors which have a mandatory GMP system in place (including testing of pharmaceuticals) the inhouse testing laboratory is required to have ISO 17025 accreditation.

Pharmaceutical GMPs generally specify the laboratory controls for testing. ISO 17025 is a compliment to GMP in this context, as it provides assurance of valid testing results and therefore confidence in the GMP control measures. For example while GMP may as a minimum require laboratories to control measurement uncertainty, ISO 17025 requires laboratories to evaluate and estimate measurement uncertainty.

Have a look at a similar question Applicability of 17025 to GMP analytical laboratory at 
https://community.advisera.com/topic/applicability-of-17025-to-gmp-analytical-laboratory/ which also include the links to the following articles that may be of interest:

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Naomi Jan 11, 2022

Hi, My question is if you are a ISO 17025 certified lab, do you need to have GMP? 

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Tracey Evans Jan 13, 2022

You asked

if you are a ISO 17025 certified lab, do you need to have GMP?

No, GMP is not a requirement for laboratories to be ISO 17025 accredited. GMP is sector specific. Testing and calibration laboratories support GMP certified organisations and in certain cases need to / can be GMP certified, independent of ISO 17025 accreditation. Pharmaceutical GMPs generally specify the laboratory controls for testing. ISO 17025 is a compliment to GMP in this context.

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Naomi Jan 14, 2022

Thank you so much that is what I thought, so being ISO 17025 accredited enough and we don't need to get FDA compliance to GMP. We are a test house and our customers think we need to be GMP compliant because they have named us on their drug licence does that change anything? 

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Tracey Evans Jan 17, 2022

Yes this does change your Quality management system (QMS) requirements. My response previously was that an ISO 17025 laboratory does not need to meet GMP as a mandatory requirement. However if your client as a company needs a GMP license to say produce pharmaceuticals, then as their testing lab they have specific GMP compliance requirements of you. Your client needs to communicate clearly what they need and the laboratory needs to understand what additional requirements you need to meet and include them in you QMS. There are country specific regulations, depending on the reason for GMP (e.g medical devices or pharmaceutical), so you should establish from the client what is specifically required of you.

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Naomi Jan 18, 2022

That's great, thank you for clarifying, I'm getting a better understanding and your advise really is helpful. 😊 

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Marie Oct 17, 2022

How is a pharmaceutical company performing it's own drug stability testing in their own lab required to be certified?

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Aug 31, 2020

Oct 17, 2022

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