Operational Qualification (OQ)

During the Operational Qualification (OQ) stage, equipment/systems are tested in an operational (powered) state. This involves verifying the proper functioning of all individual system functions. At this stage, process and auxiliary utilities/power sources with appropriate parameters (such as pressure, temperature, etc.) required for the operation of the equipment must be available. However, the testing does not involve the use of actual products/materials, production of test batches, or similar operations.

There are also specific types of documents whose review is traditionally postponed to the Operational Qualification stage because they are typically not yet available at the time when Installation Qualification (IQ) is conducted. These documents may include:

Certain system test protocols performed by the supplier that require the system to be powered on at the client's site, such as Input/Output (I/O) Test protocols, Alarm Test protocols, etc.
Procedures describing the operation of the system, such as SOPs, work instructions, and so on (this documentation is usually developed by the pharmaceutical manufacturer).
In some cases, the final version of the Operation Manual, particularly for systems controlled by custom-programmed algorithms designed for the client, may also be finalized after the completion of the Installation Qualification, as programming and system configuration may be completed later.

EU GMP Guidelines Annex 15: Qualification and Validation provides the following definition of Operational Qualification (OQ):

“Operational Qualification (OQ): The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.”

Annex 15 also defines the following requirements regarding Operational Qualification (OQ):

“…3.10. OQ normally follows IQ but depending on the complexity of the equipment, it may be performed as a combined Installation/Operation Qualification (IOQ).

3.11. OQ should include but is not limited to the following:

i. Tests that have been developed from the knowledge of processes, systems and equipment to ensure the system is operating as designed;

ii. Tests to confirm upper and lower operating limits, and /or “worst case” conditions.

3.12. The completion of a successful OQ should allow the finalisation of standard operating and cleaning procedures, operator training and preventative maintenance requirements…”

The Operational Qualification (OQ) can only be conducted after the successful completion of the Installation Qualification (IQ). In certain cases, particularly for small-scale or less complex systems, or standard systems delivered in an enclosed casing that does not require user manipulation inside, the IQ and OQ stages may be combined into a single phase known as Installation and Operational Qualification (IOQ).

The verification process is conducted based on a pre-established qualification protocol containing control points and predefined acceptance criteria, typically presented in tabular format. Before qualification begins, the protocol must be approved for use, and no changes to the wording of the control points or acceptance criteria are permitted during the qualification process.

During the qualification, the protocol is filled out, and once all control points have been checked, a qualification report is prepared. This report may either be the completed qualification protocol itself or a separate document summarizing the results of the qualification process.

The specialists at Tarqvara Pharma Technologies have years of experience in conducting qualification, validation, and acceptance tests within the pharmaceutical industry, in full compliance with international, European, and national GMP/GxP regulations and standards.