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ISO 17025 requirements for Pharmaceutical organization

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Guest user Created:   Jan 05, 2021 Last commented:   Jan 05, 2021

ISO 17025 requirements for Pharmaceutical organization

What are ISO 17025 requirements for Pharmaceutical organization?

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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 Jan 05, 2021

ISO 17025 requirements apply to all laboratories for all testing, calibration and sampling. The Pharmaceutical sector, as for any other sector or accreditation program such as, e.g. Veterinary or Pesticide analysis for product registration; have national and perhaps international regulatory requirements. The requirements depend on what the “Pharmaceutical organization” activities are. A production QC laboratory might. for example, be ISO 17025 accredited as per “general” requirements for Chemical Testing. Typically an accreditation body would have a program for Pharmaceutical Laboratories or include Pharmaceutical biological, microbiological and biochemical testing and measurement under the Biological Programme. The requirements would depend on the scope which could be, for example,  Drug testing, Chemical Analysis or Pharmaceutical Testing.

I recommend you look at your accreditation body website or call them to obtain specific requirements.

For a list of accreditation bodies have a look at https://ilac.org/signatory-search/

For more information on ISO 17025 see

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Jan 05, 2021

Jan 05, 2021

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