What is the 3Q certification of the constant temperature and humidity incubator?

Constant temperature and humidity incubator in the 3Q certification a. 3Q Introduction If it is a complete set of instruments (or equipment) validation program, will include four parts, that is, 4Q, respectively:

DQ, design confirmation (Design Qualification), to confirm that the design of the equipment in line with user requirements specifications and related regulations.

IQ, Installation Qualification, confirms the instrument documentation, components and installation process.

OQ, Operational Qualification, confirms that the instrument is capable of normal operation under idle conditions and within the limits of operation.

PQ, Performance Qualification, confirms that the instrument complies with the standard when running with samples.

As the instruments used in the laboratory have been developed and designed by instrument manufacturers, DQ (design confirmation) in the instrument verification can not be done, 3Q verification refers to the above IQ (installation confirmation), OQ (operation confirmation), PQ (performance confirmation). That is to say, laboratory instrument validation is done from IQ (installation confirmation), and then do OQ (operation confirmation), PQ (performance confirmation), to complete a set of instrument validation of the whole set of information.

II. Instrument category introduction and validation of instrument classification According to the pharmaceutical industry to produce different varieties, from the dosage form, there are powder injection, API, solid preparations, etc., and different drugs also have different testing programs, the laboratory instruments, mainly to meet the drug testing for the preparation, and therefore roughly divided into three categories:

For simple instruments, such as: electric furnace, ultrasonic cleaner, etc. is not required to verify, because the instrument itself is simple, and the test results can not have a direct impact, so such instruments can be omitted from the verification.

For general instruments, such as: pH meter, balance, etc. is not a precision instrument, but the state of the instrument can have a direct impact on the test results, so such instruments need to do 3Q validation, but can be abbreviated to do, is to do: IOQ, PQ, that is, the IQ (installation confirmation) and OQ (operation confirmation) synthesized into a step to do.

Precision instruments, such as liquid chromatographs, gas chromatographs and other precision instruments, 3Q verification should be done in full, that is: IQ (installation confirmation), OQ (operation confirmation), PQ (performance confirmation) to do.

3Q Instrument Steps Introduction After determining the instrument to be verified, we need to know what needs to be done in each step of 3Q verification.

1. IQ (installation confirmation), as the name suggests, is to confirm (or verify) the installation process of the instrument.    The first is the preparation of paper documents, which can be listed in the form of a table, including instrument manufacturers of instrument materials, testing and other certificates; instrument manufacturers of manuals, packing lists, lists of accessories and other information; the use of the department to prepare the standard operating procedures, maintenance records, records of use, personnel training and other documents; calibration certificates of the instrument or other components, and so on.

Next is the confirmation of the preparation of the external environment, such as room exhaust, temperature and humidity control; power supply, emergency measures for accidental power outages and so on.

The last is the confirmation of the instrument itself, according to the manual and the characteristics of the instrument itself, check whether the above preparatory work is completed, whether it is reasonable.2. OQ (operation confirmation), which is mainly to verify that the instrument in the case of idling, in the design of the instrument within the limits of the bearing can be completed in good operation, that is, a minimum limit and the maximum limit of the test of the verification. Here you need to use a lot of measuring equipment to confirm some of the functions of the instrument, such as temperature, we need to use an external temperature device to verify that the instrument itself is designed for the maximum temperature and minimum temperature, whether within the design range. Another example is the injection volume, if the injection volume is large, you can use a calibrated gauge to confirm; if the volume is small, you need to confirm through indirect methods, such as liquid phase injection accuracy, you can confirm through the continuous injection of standard samples.

3.PQ (performance confirmation), for the instrument only, this step can be simply understood as the actual sample OQ (operational confirmation), because this step is to bring in the sample for testing, there are known concentrations of samples to verify the accuracy of the instrument; there are unknown concentrations of samples to verify the instrument's ability to detect and so on. Simply put, it is the process of testing once or twice according to the sample testing method. Generally speaking, after IQ (installation confirmation) and OQ (operation confirmation) are done, PQ (performance confirmation) can also be passed successfully.