C
CalibrationQA
Hello,
First time post so be gentle.
I work for a third party calibration company that calibrates lab equipment for pharma companies. We have a new Operations Manager who is reviewing our SOP's. I should note that his experience is from working in the research side and this is his first time working for a 3rd party vendor.
In meeting with him today, he pointed out that our calibration SOP for balances is wrong because ISO, GMP/GLP and the FDA require that we do an internal calibration before capturing the "As Found" data. This is not how our SOP is written or has ever been performed before. Our SOP states that we are to measure the unit to capture the "As Found" data, perform the internal cal and measure the unit again for the "As Left" data.
Now I'm fairly certain that our ISO 17025 does not call out any specifics to this, as I just went through our audit and it was never mentioned. I also am a little wary to write a new SOP that states we perform an internal calibration prior to documenting the "As Found" data. The unit would always pass and the data would not be accurate if this is the case, in my opinion.
I guess my question and reason for posting is to see if anyone is aware of a regulation that requires this to be performed?
Thank you!
First time post so be gentle.
I work for a third party calibration company that calibrates lab equipment for pharma companies. We have a new Operations Manager who is reviewing our SOP's. I should note that his experience is from working in the research side and this is his first time working for a 3rd party vendor.
In meeting with him today, he pointed out that our calibration SOP for balances is wrong because ISO, GMP/GLP and the FDA require that we do an internal calibration before capturing the "As Found" data. This is not how our SOP is written or has ever been performed before. Our SOP states that we are to measure the unit to capture the "As Found" data, perform the internal cal and measure the unit again for the "As Left" data.
Now I'm fairly certain that our ISO 17025 does not call out any specifics to this, as I just went through our audit and it was never mentioned. I also am a little wary to write a new SOP that states we perform an internal calibration prior to documenting the "As Found" data. The unit would always pass and the data would not be accurate if this is the case, in my opinion.
I guess my question and reason for posting is to see if anyone is aware of a regulation that requires this to be performed?
Thank you!