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ISO 17025 in pharmaceutical industry

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Guest user Created:   Aug 31, 2020 Last commented:   Sep 02, 2020

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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