Pharmaceutical companies are on the rise today. The industry is booming with high ratios of dependency of the patient. The agenda of these companies is to prepare a medical drug to either use or sell it through appropriate means. They deal in generic or brand medications and devices but are bound by various restrictions on the sale and purchase of them. They are subjected to only lawful means where the product should be fully tried and tested. We, as a rising pharmaceutical agency strive and put our energy and focus so that we can provide our patients with the best. 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. During this process, there is the absence of any kind of load due to which giving accurate results is not an impossible task but these results cannot be trusted upon as they show only one side of the story. The next step is the Installation qualification (IQ) followed by Design qualification(DQ). These steps are not of much importance. The most important and crucial phase during the testing of a product is Performance Qualification (PQ). It is undeniably the only source that accurately describes whether the product is viable at all.
For instance, if we consider a homogenizer working perfectly when empty but doesn’t provide a specified rate per minute with a few kg of weight in it, then it will pass the operational qualification test but will fail in PQ. The testing is asked to verify that the performance specified in the user requirement specifications is being delivered. It is also mandatory to confirm the requirements listed in government protocols, health and safety rules and other guidance documents. For pharmaceutical companies, the objectives of the test and methodologies must all be pre-approved. It showcases the final qualification of equipment. This includes a wide range of tests to restore the production and give assured results that your system is capable of process validation activities.
If our products don’t go through PQ then they might end up in a horrid condition where it may even produce an undesired product that might harm a large group of people. We are bound by an ethical obligation in which we want to provide our customers with quality results. If these tests fail then our reputation is at stake which is highly non-acceptable by our company. Performance qualification is as mandatory as it is for a human to breathe and the time to move. If you purchase a new air conditioner, you tend to inspect it from every single aspect. Statistical programmers in the pharmaceutical world are key players in all area of research about drugs and medications from the initial progress of a chemical right to the manufacturing and commercialization of these products.
You set it on every single mode to check its cooling process, you call in for a demo to understand the system better, but does the air conditioner always works the same for years? Does it provide the same amount of cooling for the whole day? These are the questions which are answered by Performance qualification in pharmaceuticals companies related to their research on medicines. For achieving success we need to continue working hard so that the end results are complimenting the struggle to receive the best out of all.