What Is IQ-OQ-PQ Qualification Process

What Is IQ-OQ-PQ Qualification Process

The IQ-OQ-PQ qualification process is used everywhere in the world, in order to be sure that the manufacturing is of high standards and to guarantee its efficient working. Any failure in the equipment can have disastrous effects and hence a lot of money is pumped into this process and is compulsory in most countries that the pharmaceutical manufacturing industry must abide by these specifications. These are the 3 Q’s of software validation process which do quality assurance checks with the help of future customers, owners, vendors in order check its working, sustainability and quality before purchasing the product. These checks are mostly done in the production unit itself, by the operation team in order to check that all the applications are working perfectly and in a way that they are designed to. Here is what IQ OQ PQ mean:

IQ stands for Installation Qualification, and it basically means checking and confirming the new equipment and testing its material. Like if its mentioned in the manual that one needs to use 316 stainless steel and 5 force power motor, then one must make sure that these basic prerequisites are met before installation, for the product to work perfectly.

OQ stands for Operational Qualification- the next stage of checking the product. In this particular phase, the product is tested to check whether it fulfills its promise of working on the claimed parameters, like for example, if the machine is suppose to work in a range of 50-150 RPM and will utilize a particular amount of power, it’s necessary that to check that it works perfectly on the mentioned specifications. One must reconfirm the parameters, challenge them, test them again and be very sure that it works well, the way it has claimed to work.

PQ stands for Performance Qualification is the equipment’s final test. Just like we do in the OQ phase, the product is tested in the performance stage as well, but with actual load, that it is suppose3d to handle. In the OQ stage the equipment is tested, if it works at the range of 50 -150 RPM, and it does, but in the performance stage it is tested, that will the same equipment still work in the same range with 250 kilos of material in it. If yes, then the equipment is ready for utilization.

 

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