Operational Qualification in Pharmaceutical Industry

Operational qualification has a vital role in ensuring high-quality products are being consistently manufactured. It is the third stage in the equipment qualification process. Operational qualification in pharmaceutical industry validates all equipment and sub systems operate as intended under all anticipated conditions. Notably, operational qualification (OQ) is fundamental for achieving operational excellence, regulatory compliance, and maintaining trust in the pharmaceutical manufacturing process. In this blog, we have discussed what is operational qualification and importance of OQ in pharma industry.

What is operational qualification in pharmaceutical industry?

Operational qualification in pharmaceutical industry ensures all equipment consistently and reliably operate within predefined specifications. It involves a series of tests used to confirm the equipment is working as it is claimed to be by the manufacturer. Furthermore, critical functions, controls, and alarms are also tested under various conditions to ensure reliable performance. Operational qualification (OQ) assesses whether the equipment is operating consistently with user requirements and manufacturer specifications. Furthermore, the OQ phase should follow a specific protocol that ensures the effectiveness of the tests and accuracy of the results. Additionally, the OQ protocol should be detailed enough to allow replication of results by different testers. The OQ phase is carried out after the installation qualification phase and verifies the equipment or system operates as intended within specified parameters. Thus, OQ in pharma industry is used to demonstrate the equipment is capable of consistent operation under specified parameters.

Practical examples of performing operational qualification in pharmaceutical industry:  A tablet compression machine is assessed to ensure it consistently produces tablets of specified weight and hardness. On the other hand, OQ tests are performed to confirm whether an autoclave is operating as intended. Whether the autoclave can achieve the required temperature (121 °C) and pressure (15 psi) during the sterilization process is checked. Furthermore, its safety and emergency features are checked.

6 key roles of operational qualification in pharmaceutical industry

Pharmaceutical equipment operational qualification phase ensures operational reliability. OQ plays the following roles in the pharmaceutical industry:

1. Operational reliability: One of the most important roles of operational qualification in pharmaceutical industry is ensuring reliability and consistency in equipment operation.
2. Ensuring product quality: By verifying the equipment operates as intended within predefined parameters, OQ helps ensure consistent production of high-quality pharmaceuticals.
3. Regulatory compliance: Most regulatory authorities require pharma companies to perform OQ. Furthermore, conducting an effective OQ is vital for demonstrating compliance with most industry regulations, such as GMP.
4. Risk mitigation: Operational qualification helps identify and resolve potential operational issues before full-scale production begins. Thus, it helps prevent costly downtime, recalls, or operational failures.

5. Data integrity: Thorough documentation is a requirement of operational qualification. It ensures traceability and accountability, thereby providing an audit trail.
6. Foundation step for performance qualification: Operational qualification is a necessary step in the equipment qualification process. It ensures the pharma equipment is ready for real-world performance qualification. Thus, OQ bridges the gap between installation qualification and performance qualification phases.

OQ protocol and necessary documents required

1. OQ protocol: A robust OQ protocol has to be developed. It must cover the following components:
   • What objectives are expected to be achieved have to be mentioned. Additionally, specific operational parameters and functions to be tested have to be outlined.  
   • The equipment, systems, and sub systems within the scope of OQ have to be mentioned.
   • The OQ procedure for conducting the operational tests has to be described step by step. Furthermore, any prerequisites have to be mentioned.
   • The OQ criteria for acceptance has to be defined. The criteria must be based on the manufacturer’s specifications, regulatory requirements, and user needs.
2. Standard operating procedure: A standard operating procedure or SOP has to be developed. This will be required for the correct and consistent working of the pharma equipment in the operational tests.
3. OQ checklist: A detailed operational qualification checklist has to be prepared. It has to be referred to while conducting the tests specified in the OQ protocol.
4. Traceability matrix: A traceability matrix is required to ensure appropriate operational parameters are tested and validated against the requirements.
5. Equipment calibration and maintenance record: Equipment calibration and maintenance records have to be maintained before as well as during the operation qualification tests. These records are an important part of the vital documents required for OQ in pharma industry.
6. OQ report: Furthermore, OQ protocol requires a detailed OQ report preparation. It should be used to record OQ test findings and outcomes.

Importance of an operational qualification (OQ) report

The operational qualification (OQ) report is a vital document for the qualification process for pharmaceutical equipment and systems. A robust OQ report is required not only to fulfil regulatory obligations but also to demonstrate operational excellence.

• The operational qualification report captures test results, observations, deviations, and corrective actions during the OQ process. This is required to ensure traceability and accountability.
• A well-prepared OQ report will help streamline inspections.
• An OQ report is used to demonstrate the pharma equipment and system operate per defined regulatory requirements as well as adheres to the GMP guidelines.
• The OQ report is necessary for internal quality reviews and external audits carried out by regulatory authorities.
• It provides critical data and insights needed for the next equipment qualification step.

Hence, it is important to carefully prepare the OQ report while performing operational qualification in pharmaceutical industry.

What are the steps of the pharmaceutical equipment operational qualification process?

1. OQ protocol: A detailed OQ protocol outlining the tests to be performed has to be prepared. The protocol should include the objectives, acceptance criteria, procedures, and testing responsibilities.
2. Preparation for the OQ tests: Ensure all equipment have been properly installed and have successfully passed the IQ phase. Furthermore, calibrate all equipment and ensure all utilities are properly connected.
3. Execute equipment functionality tests: Test key operating parameters of the equipment under normal and challenging conditions. Additionally, check safety features, such as alarms, emergency stop functions, and interlocks.
4. Check reproducibility of the test results: The pharma equipment has to be tested multiple times to ensure consistent and repeatable performance of the equipment.
5. Record any deviations and corrective actions implemented: Check for deviations from the expected results. If necessary, rerun the tests to meet acceptance criteria. Furthermore, implement corrective actions to avoid recurrence of these deviations in the future. Ensure the deviations and corrective actions implemented are properly recorded.
6. Prepare a detailed OQ report: The OQ protocol mandates the preparation of a detailed OQ report recording the entire OQ process. It should include the test results, deviations, corrective actions, and recommendations for the next qualification step.
7. Secure approval from all concerned departments: The OQ report has to be vetted by all concerned departments.

The operational qualification process steps collectively ensure the equipment and system can reliably and consistently operate as intended. Additionally, they are required for a smooth transition to the performance qualification phase.

Can we perform OQ before IQ?

No, OQ cannot be performed before IQ. To assess the operation of the equipment, it must be installed properly. The IQ phase is required to validate there are no errors in equipment installation. Additionally, whether all conditions necessary for operating the equipment have been fulfilled has to be checked in the IQ phase. After validating these parameters, OQ can be performed.

Therefore, operational qualification plays a crucial role in pharmaceutical industry. By validating equipment operational reliability, the OQ in pharma industry contributes to consistent product quality and patient safety. Hence, performing operational qualification in pharmaceutical industry is mandated by most regulatory authorities. However, performing equipment qualification in pharma industry can be challenging. Thus, we at Pharmadocx Consultants provide customised regulatory support to our clients. To navigate the regulatory guidelines in a hassle-free manner, email at [email protected] or call/Whatsapp on 9996859227.