Hello everyone,
I'd have a tricky question.
For the controlled room monitoring, we have an agreement with the lab measuring the contamination of air and surfaces (bioburden). This lab has a GMP certificate focused on: 1 Manufacturing operation (Batch certification and Quality control testing) 2 Importation of medicinal products, etc.
For the measurement of the material contamination (bioburden), we have an agreement with the lab which is 17025 certified (for determination of endotoxins, bioburden etc).
And for the measurement of the particle count, we have an agreement with the lab which is also 17025 certified.
My question is, shouldn't we require the same certification from all labs or is this attitude correct? How can we prove the auditor the correctness of this choice (if it is correct). Still, it does'nt seem to be clear for the companies how to choose the testing lab based on the certification.
Thanks a lot!
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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
ISO 17025 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
I gather from your comments that you are the facility having your “controlled room “ monitored for various contamination ?
I do not follow if your facility is GMP or if you are accredited to ISO 17025. In either case your management standard and legal regulations will dictate what accreditation or certification is required of your service providers. ISO 17025 requires a facility to identify what you need, the risks and to select suitable competent providers. Typically you would use ISO 17025 accredited testing laboratories. They need to have the specific test methods on their scope of accreditation as listed on the scope attached to their certificate.
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Dec 21, 2022