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Operational qualification, or OQ, is an essential process often used by pharmaceutical companies during the development of equipment. OQ can be simply defined as a series of tests that ensure that equipment and its subsystems will operate consistently and reliably within their specified limits.
In other words, the equipment and its sub-systems will do what they are supposed to do so that its products will be identical. Some examples of subsystems that are tested during OQ are safety systems, recording systems, and counting or measuring systems. Some pieces of equipment tested may include scales, mixing equipment, conveyor belts, molds, or dryers.
Equipment may also be tested during OQ for qualities such as expected and acceptable power consumption or maintaining a specified temperature for a predetermined period of time. Functional qualification of equipment follows a specific procedure to ensure thoroughness of testing and accuracy of results. The protocol must be detailed and easily replicable so that the equipment can be tested multiple times by different testers. This ensures that test results are reliable and do not vary from tester to tester or throughout the manufacturing process.
The first step in the process is to write the OQ into a protocol that states the objectives, specific test methods, and acceptable results for the equipment being tested.
The protocol is then reviewed to ensure that tests include all required functions of the equipment. Additionally, expectations and acceptable results are reviewed to ensure that they truly represent what is desirable during the performance of the equipment.
After reviewing the protocol, an investigator will follow detailed instructions for the OQ. The examiner shall record the test results and compare the results with the acceptable results previously described. If there is a difference between the result and the acceptable result, it is noted and reviewed to determine the cause of the deviation.
Operational qualification of equipment is an important step towards developing safe and effective equipment. In the pharmaceutical business, it is especially important to thoroughly test the equipment before the product is available for production. Pharmaceutical equipment must produce highly specific products accurately, reliably and consistently. This ensures that the product is safe and effective, and prevents damage or wastage of the product’s expensive components.
