Dear All,
I have a query regarding the calibration of IPQA instruments. Can anyone suggest as to who has to perform Calibration of instruments Production or Quality Assurance? And the logic or any guideline to support the choice?
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calibration is done by outside party who has approval NABL certified that party can be done the calibration of instrument…
Thanks for your valuable suggestion. But would further like to know if the calibration is to be done in-house then , who is responsible?
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if possible in-house calibration by engineering but its very skillful and time consuming work and also be Required standard instrument calibration with NABL certified so as per your scope what type you can do…
My suggestion like that you have to do by external agency…
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In Process Quality Assurance (IPQA) is the responsibility of QA function to ensure that manufacturing activities on the production floor are conducted according to CGMP as well as product batches are manufactured according to the insructutions in Batch Records (BMR & BPR) and internal SOPs, in-process samples are tested in IPQC / IPQA lab on the production floor as per specifications and established test methods. Therefore, in principle the responsibility of calibration of instruments is with Quality Assurance (or Quality department). QA can get the calibration wotk done through internal Engineering department or external calibration laboratory accredited by NABL or equivalent standard.
While, the tests of in-process samples during production which are performed by production personnel, the calibration of such instruments is the responsibility of production. However, production can get this done through either internal Engineering department or external calibration laboratory.
In any case QA has to approve the external calibration laboratory (Vendor qualification) as well as review the calibration certificates (both internal and external).
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