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3Q certification refers to IQ (installation confirmation), OQ (operation confirmation), and PQ (performance confirmation)
Which instruments require 3Q certification?
Instruments that are simple in design and have no direct impact on test results do not need validation. For non-precision instruments whose condition still directly affects test results, a simplified validation can be conducted, i.e., only performing OQ (Operational Qualification) and PQ (Performance Qualification). However, for precision instruments such as chromatographs and mass spectrometers, a full 3Q validation is required, including IQ (Installation Qualification), OQ, and PQ.
There is a wide variety of laboratory instruments and equipment. If classified by their calibration attributes, they can be broadly divided into three categories:
Any equipment used for pharmaceutical measurement and other matters related to product release falls into this category. For these devices, it is necessary to
For this type of instrument, users are required to calibrate it before use. Users must verify the instrument using reference standards or calibration reference standards, and record the instrument's condition in the laboratory logbook as part of the data for sample analysis.
There is another category of instruments that do not require calibration, as they are neither used to generate data nor for submitting official inspection documents, so calibration is unnecessary.
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