ISO 17025 requirements for Pharmaceutical organization

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

• The whitepaper Clause-by-clause explanation of ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/clause-by-clause-explanation-of-iso-17025/
• The ISO 17025 toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/