The operational qualification is a series of tests done to check and clarify the proper operation of a system. The test requirements outlined in the functioning requirements and specification. The tests should all take place before the system s taken out for use or sale. Depending on the individual needs and how complicated the system is, operational qualification may be done together with the performance and installation qualification. This process is essential during the development and manufacture of systems and equipment usually used by pharmaceutical companies. The systems should be able to fully operate within the required and the specified limits in a dependable manner. The material should, in other words, run as they are required to and produce uniform products.
Operational qualification may be applied to test such cases as each screen of the equipment accepts the appropriate data entered. Also that a given flow can be worked consistently through an entire workflow and that the overall security of the system has adequately implemented and the fact that all the technical installations of the equipment are running as expected and give the required outputs. There are other sub-systems also tested while running operational qualification which includes; recording systems, measuring systems, storage systems, executive systems, monitoring systems and the calculating systems. The particular parts of the pharmaceutical equipment tested include its mixing apparatus, the scales, dryers, molds, display equipment, safety guards and the conveyor belts. The system may also check for its quality measures during operational qualification for certain aspects such as using the acceptable and predetermined ratio of power or keep a given temperature for a given period and monitor for any variations if they are as per the given limits.
Operational qualification will follow a given procedure to make sure that it is through with the test carried out and the results were all accurate. It’s a protocol that is highly detailed and quickly transformed into varying forms to make sure that the system tested under all possible aspects and multiple times by separate testers. By doing this, the results attained can be much reliable, and they are not varying among the testers or show differences all through the manufacturing line.
The operational qualification process takes place in steps and adequately outlined procedures. The initial phase as per the protocol shows specific techniques to be followed in testing, the objectives of performing the test and the possible outcomes of the trial that will be accepted. The said protocol is accessed to make sure that the tests are as per all the functions of the system or equipment. Also, the expected and possible outcomes are also reviewed to make sure that they are realistic and they represent all that is wanted when the apparatus is functioning.
After all the reviews of the protocol are completed, a tester will follow all the given instructions of the operational qualification. They will have to keep a clear record of the results to the agreeable outcomes that had been stated before. If a variation comes up between the results and the acceptable findings, it is put down to note, and arrangements are made to review the source of the deviation.
Finally, after the review, the equipment may be taken back to the engineers who will determine the cause of the problem. Operational qualification is an important and a recommended step along the process of developing and manufacturing safe and efficient pharmaceutical equipment and systems.