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If you are in the instrument industry, it is no stranger to the term 3Q certification. Let Jingda explain the 3Q certification for you:
Because the instruments used in the laboratory are all designed and developed by instrument manufacturers, DQ (Design Confirmation) may not be used in instrument verification. Therefore, 3Q mentioned in this paper refers to the above IQ (Installation Confirmation), OQ (Operation Confirmation), and PQ (Performance) confirm). In other words, the laboratory equipment verification starts from IQ (installation confirmation), and then OQ (operation confirmation) and PQ (performance confirmation) are performed, and a complete set of instrument verification data is completed.
The purpose of doing 3Q certification: through the series of activities such as DQ (design confirmation), FAT (manufacturing factory test), IQ (installation confirmation), OQ (operation confirmation), and PQ (performance confirmation), the data and conclusions provided can prove that Equipment in the production can meet the needs of the production process, equipment performance in line with design requirements, product standards and national GMP requirements.
Purpose of IQ verification: Provide a series of test data through on-site installation, commissioning, and verification activities to prove that the installation documents, installation conditions, and installation results of the drug stability test kit meet the design requirements. The data and documents meet the GMP management requirements.
The purpose of OQ confirmation is to first check the inspection report of the instrumentation provided by the verifier, check and test the technical parameters of the equipment operation, confirm that the operational performance of the stability test box meets the design requirements, and comply with the relevant requirements of GMP.
Purpose of PQ verification: Based on the installation confirmation and operation confirmation, according to the specific production process of the manufacturer, similar test products are added for testing to confirm that the equipment performance meets the design requirements and meets the relevant requirements of GMP. Detailed text data is provided during on-site verification.
Which products need to do 3Q certification:
3Q certification is a quality system certification, the most common in some precision instruments. If it is a complete instrument (or equipment) verification program, it will include 4 parts, namely 4Q, which are:
DQ, design confirmation. Confirm that the design of the equipment meets the user's requirements and related regulations.
IQ, installation confirmation. Confirm instrument files, parts and installation process
OQ, operation confirmation. Make sure that the instrument can run normally within the limit of the operation when it is idle.
PQ, performance confirmation. Verify that the instrument is running in accordance with the standards.
Because the instruments used in the laboratory are all designed and developed by instrument manufacturers, DQ (Design Confirmation) may not be used in instrument verification. Therefore, 3Q mentioned in this paper refers to the above IQ (Installation Confirmation), OQ (Operation Confirmation), and PQ (Performance) confirm). In other words, the laboratory equipment verification starts from IQ (installation confirmation), and then OQ (operation confirmation) and PQ (performance confirmation) are performed, and a complete set of instrument verification data is completed.
The purpose of doing 3Q certification: through the series of activities such as DQ (design confirmation), FAT (manufacturing factory test), IQ (installation confirmation), OQ (operation confirmation), and PQ (performance confirmation), the data and conclusions provided can prove that Equipment in the production can meet the needs of the production process, equipment performance in line with design requirements, product standards and national GMP requirements.
Purpose of IQ verification: Provide a series of test data through on-site installation, commissioning, and verification activities to prove that the installation documents, installation conditions, and installation results of the drug stability test kit meet the design requirements. The data and documents meet the GMP management requirements.
The purpose of OQ confirmation is to first check the inspection report of the instrumentation provided by the verifier, check and test the technical parameters of the equipment operation, confirm that the operational performance of the stability test box meets the design requirements, and comply with the relevant requirements of GMP.
Purpose of PQ verification: Based on the installation confirmation and operation confirmation, according to the specific production process of the manufacturer, similar test products are added for testing to confirm that the equipment performance meets the design requirements and meets the relevant requirements of GMP. Detailed text data is provided during on-site verification.
Which products need to do 3Q certification:
For simple instruments: for example: electric furnaces, sinks, ovens, etc. do not need to be verified, because the instrument itself is simple, and the test results can not have a direct impact, so this type of instrument can omit the verification.
For general instruments: For example, precision incubators, constant temperature and humidity oscillators , constant temperature oscillators, etc. are not precision instruments, but the instrument state can directly affect the test results. Therefore, such instruments need to be verified by 3Q, but they can be simplified. To do is to do: IOQ, PQ, that is to combine IQ (installation confirmation) and OQ (operation confirmation) to do a step.
For precision instruments: such as light incubators, artificial climate chambers, CO2 incubators, constant temperature and humidity chambers, integrated drug stability test chambers and other precision instruments, 3Q verification should be done in full, namely: IQ (installation confirmation), OQ (operation confirmation ), PQ (performance confirmation) all done.
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