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Performance Qualification (PQ)
Pharmaceutical companies are booming today. The industry is booming with high levels of patient dependency. The agenda of these companies is to prepare the medicinal product for use or for sale by suitable means. They deal in generic or brand-name drugs and devices, but are bound by various restrictions on their sale and purchase. They are only exposed to legal means where the product should be fully tried and tested. As a growing pharmaceutical agency, we strive and devote our energy and focus to provide the best to our patients. Companies like us go through a series of steps on the ladder of providing fully trusted products.
The easiest phase of all is the Operational Qualification (OQ) phase as it is considered a walk in the park. There is no load during this process, which makes providing accurate results not an impossible task, but these results cannot be trusted because they only show one side of the story. The next step is Installation Qualification (IQ) followed by Design Qualification (DQ). These steps are not of much importance. The most important and decisive stage during product testing is performance qualification (PQ). It is undoubtedly the only source that accurately describes whether a product is even viable.
For example, if we consider that the homogenizer works perfectly when empty, but does not provide the specified speed per minute with a few kg of weight, then it will pass the serviceability test but fail the PQ. Testing is required to verify that the performance specified in the user requirements specifications is provided. It is also mandatory to confirm the requirements listed in government protocols, health and safety regulations and other guidelines. For pharmaceutical companies, test objectives and methodology must be approved in advance. It represents the final qualification of the device. This includes a wide range of production recovery tests and provides guaranteed results that your system is capable of process validation activities.
If our products do not pass PQ, they can end up in a terrible state where they can even produce an unwanted product that could harm a large group of people. We are bound by an ethical obligation in which we want to provide quality results to our customers. If these tests fail, our reputation is at stake, which is highly unacceptable for our company. Performance qualification is as mandatory for a person as breathing and time to move. If you buy a new air conditioner, you tend to check it from all sides. Statistical programmers in the pharmaceutical world are key players in all areas of drug and drug research from the initial development of chemical law to the manufacture and commercialization of these products.
You set it in every single mode to check its cooling process, call for a demo to better understand the system, but does the air conditioner always work the same for years? Does it provide the same amount of cooling throughout the day? These are the questions answered by performance qualifications in pharmaceutical companies related to their drug research. In order to achieve success, we must continue to work hard so that the end results match the efforts to get the best out of everyone.
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