Operational Qualification, or OQ, is an essential process during the development of equipment often used by pharmaceutical companies. OQ can simply be defined as a series of tests which ensure that equipment and its sub-systems will operate within their specified limits consistently and dependably.
In other words, the equipment and its sub-systems will do what they are supposed to do so that its products will be uniform. Some examples of sub-systems that are tested during OQ are security systems, recording systems, and calculating or measuring systems. Some parts of the equipment tested may include scales, mixing apparatuses, conveyor belts, molds, or dryers.
Equipment may also be tested during OQ for qualities such as using an expected and acceptable amount of power or maintaining a certain temperature for a predetermined period of time. Operational Qualification of equipment follows a specific procedure to ensure thoroughness of the tests and accuracy of the results. The protocol must be detailed and easily replicated so that the equipment can be tested multiple times by different testers. This ensures that the results of the tests are reliable and do not vary from tester to tester or vary throughout the manufacturing process.
The first step in the procedure is that the OQ is written in a protocol that states the objectives, specific methods of testing, and acceptable outcomes for the equipment being tested.
The protocol is then reviewed to ensure that the tests are encompassing all essential functions of the equipment. Additionally, the expectations and acceptable outcomes are reviewed to ensure that they really represent what is desirable during equipment function.
Related:Performance Qualification (PQ) of Pharmaceutical Equipment
After the protocol is reviewed, a tester will follow the detailed instructions of the OQ. The tester will record the results of the tests and compare the results to the previously stated acceptable outcomes. If there is a difference between the result and the acceptable outcome, it is noted and will be reviewed to determine the cause of the deviation.
Related:Installation Qualification (IQ) in Pharmaceuticals
Finally, if deviations from the acceptable outcomes are present, the equipment engineers must determine the cause of the problem. The problem must be rectified before the equipment can become available for use and retested to ensure that the deviation will not reoccur. In these steps, it becomes clear what the true purpose of OQ is: to ensure that given the limits and abilities of the system, it will repeatedly and reliably produce the intended results.
Related:Design Qualification (DQ) of Equipment
Operational Qualification of equipment is an important step along the path of developing safe and effective equipment. In the pharmaceutical business, it is especially important to test equipment thoroughly before it is available for manufacturing products. Pharmaceutical equipment has to manufacture extremely specific products exactly, reliably, and invariably. This ensures that the product is safe and effective, and also prevents the loss or waste of expensive components of the product.
The highly specific procedure for Operational Qualification helps to guarantee that these important objectives are met. Although it is only a short portion of the process for equipment testing, it is a critical procedure that protects the interests of both the producer and consumer in the pharmaceutical industry.
Related:Download Operational Qualification Sample Protocol
FAQs
OQ's purpose is to determine that equipment performance is consistent with the user requirement specification within the manufacturer-specified operating ranges. In action, this means identifying and inspecting equipment features that can impact final product quality.
What is OQ in pharmaceutical industry? ›
Operational Qualification (OQ)
Operational qualification is the next step in quality assurance and involves testing the equipment and making sure it performs as specified, within operating ranges as listed by the manufacturer.
What is operational qualification in GMP? ›
Operational qualification involves testing all the different functions of the equipment and establishing the operational parameters of the device, which may include: Displays and operational signals, such as LEDs. Temperature fluctuation controls. Humidity measurement and control systems.
What are OQ standards? ›
Wechsler Intelligence Scales
| IQ Range ("deviation IQ") | IQ Classification |
|---|
| 130 and above | Very Superior |
| 120–129 | Superior |
| 110–119 | High Average |
| 90–109 | Average |
3 more rowsThe Operational Qualification Protocol is a collection of test cases used to verify the proper functioning of a system. The operational qualification test requirements are defined in the Functional Requirements Specification. Operational Qualification is usually performed before the system is released for use.
What are IQ OQ and PQ and why are they required in the pharmaceutical industry? ›
IQ stands for Installation Qualification, OQ for Operational Qualification, and PQ for Performance Qualification. The purpose of process validation is to establish documented evidence that the production equipment is correctly installed, operates according to requirements, and performs safely.
What is the OQ validation process? ›
The OQ phase verifies that equipment functions correctly, meets performance specifications, and operates reliably under normal operating conditions. This validation phase is paramount to ensure that equipment or systems can consistently deliver intended functionality.
What is an example of an operational qualification? ›
For example, for a heat-sealing process, your input factors are temperature, time, and pressure, while your output factor could be seal strength. Next, you run your operation in worst-case settings or worst-case situations. In the case of our heat-sealing process, upper limits could be 160°C, 2.5 hours, and 3.5 PSI.
What are the types of operational qualification? ›
OQ testing typically includes performance tests, functionality tests, and stress tests to evaluate the equipment's capabilities under different operating conditions. It may involve testing sub-systems, interfaces, and integrated processes to ensure the proper functioning and interconnectivity of all components.
What does OQ mean in manufacturing? ›
Operational Qualification (OQ)
Tests and documents that the equipment and systems operate as intended and are within the operating ranges listed by the manufacturer.
The nine integrating companies are:
- Oman Oil Company.
- Orpic.
- Oman Oil Company Exploration and Production.
- Oman Gas Company.
- Duqm Refinery.
- Salalah Methanol Company.
- Oman Trading International.
- OXEA.
This rule, which was adopted into the Code of Federal Regulations, requires pipeline operators to document that certain employees have been adequately trained to recognize and react to abnormal operating conditions that may occur while performing specific tasks.
What is validation protocol in pharmaceutical industry? ›
In the Pharmaceutical industry, Validation protocol and/or Qualification protocol list a set of procedures (tests to be performed) used to check if a product meets the proper requirements of its intended purpose.
What is OQ in analytical chemistry? ›
OQ – Operational Qualification
The primary purpose of the OQ is to determine that equipment performance is consistent with the user requirement specification. Because this a prerequisite for acceptance of equipment in the facility, OQ can only be conducted after a successful IQ.
What is an example of a performance qualification? ›
Performance Qualification Examples
For example, a performance qualification might demonstrate: That a system can handle multiple users without significant system lag. That when the system contains large quantities of data, queries are returned in a certain (short) period of time.
What is the meaning of operation qualification? ›
Quick Definition
OQ involves testing and verifying the system's performance and functionality under normal operating conditions. This validation step ensures that the equipment or software functions as expected, produces reliable results, and meets the predetermined acceptance criteria.
Equipment may also be tested during OQ for qualities such as using an expected and acceptable amount of power or maintaining a certain temperature for a predetermined period of time. Operational Qualification of equipment follows a specific procedure to ensure thoroughness of the tests and accuracy of the results. The protocol must be detailed and easily replicated so that the equipment can be tested multiple times by different testers. This ensures that the results of the tests are reliable and do not vary from tester to tester or vary throughout the manufacturing process.