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Pharma Industry stance on ISO 17025 Accreditation - In-House Calibration Laboratories

1

10133129

#1
From what I've been able to determine is the FDA does not require in-house calibration labs to be 17025 compliant. Anyone aware of what the pharma industry stance is on this? Right now my shop is not accredited but if we outsource work, the 3rd party must be accredited.
Thanks
 
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Stijloor

Staff member
Super Moderator
#2
Re: Pharma Industry stance on ISO 17025 Accreditation - In-House Calibration Laborato

From what I've been able to determine is the FDA does not require in-house calibration labs to be 17025 compliant. Anyone aware of what the pharma industry stance is on this? Right now my shop is not accredited but if we outsource work, the 3rd party must be accredited.
Thanks
Can someone help with this?

Thank you!!

Stijloor.
 
T

The Specialist

#3
Re: Pharma Industry stance on ISO 17025 Accreditation - In-House Calibration Laborato

I am by no means a calibration guru; however, my understanding is that you only require test instrumentation/materials to be traceable to national standards.
That is to say that you will be required to have your test equipment calibrated, traceable to your national standard, by an accredited laboratory.

Your in-house instrumentation is then tested (by a trained, competent person) using said test instruments which provides the traceability.
 
T

The Specialist

#4
Re: Pharma Industry stance on ISO 17025 Accreditation - In-House Calibration Laborato

I should add that I have assumed that you are ISO 9001...

Essential to conducting in-house calibrations:

Effective QMS
Appropriate plans and procedures
Appropriate methods
Competent, trained personnel
Unique identification of instrumentation
Appropriate schedule of calibration (risk/criticality based)
National/International Standard traceability
 
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