Operational qualification is a series of tests performed to verify and clarify the proper functioning of a system. The test requirements described in the performance requirements and specifications. All tests must be performed before the system is released for use or sale. Depending on individual needs and system complexity, operational qualification can be performed in conjunction with performance and installation qualification. This process is essential during the development and manufacture of the systems and equipment that are commonly used by pharmaceutical companies. Systems must be able to operate fully within the required and dependently specified limits. The material must, in other words, function as required and produce uniform products.
Operational qualification can be applied to test such cases as each screen on the equipment accepts the appropriate input data. Also that a given flow can be worked consistently through a complete workflow and that the overall security of the system has been properly implemented and the fact that all the technical facilities of the team work as expected and deliver the required results. . There are other subsystems also tested while running the operational qualification which includes; recording systems, measurement systems, storage systems, executive systems, monitoring systems and calculation systems. Particular parts of the pharmaceutical equipment tested include its mixing apparatus, scales, driers, molds, display equipment, safety guards, and conveyor belts. The system can also check its quality measurements during operational qualification for certain aspects, such as using the default, acceptable power ratio or maintaining a given temperature for a given period and monitoring any variances if they are within given limits.
Operational qualification will follow a certain procedure to make sure you are done with the test done and the results are all accurate. It is a protocol that is very detailed and quickly morphs into various forms to ensure that the system is tested in every aspect possible and multiple times by independent testers. By doing this, the results obtained can be much more reliable and do not vary between testers or show differences along the manufacturing line.
The operational qualification process is carried out by properly delimited steps and procedures. The initial phase according to the protocol shows the specific techniques to be followed in the test, the objectives of carrying out the test and the possible results of the test that will be accepted. This protocol is accessed to ensure that the tests are in accordance with all functions of the system or equipment. In addition, the expected and possible results are also reviewed to ensure that they are realistic and represent all that is desired when the apparatus is running.
After completing all protocol reviews, a tester will follow all instructions given from operational qualification. They will have to keep a clear record of the results to the conforming results that had been said before. If a variance arises between the results and the acceptable findings, it is noted and steps are taken to revise the source of the variance.
Finally, after the review, the equipment can be returned to the engineers who will determine the cause of the problem. Operational qualification is an important and recommended step in the process of developing and manufacturing safe and efficient pharmaceutical equipment and systems.
