Process Validation IQ, OQ, PQ for Medical Device

Process Validation is a crucial aspect of the medical device manufacturing process to ensure that the products consistently meet the desired quality standards. It involves three main stages: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). These stages help establish the reliability and robustness of the manufacturing process.

1. Installation Qualification (IQ):

IQ involves documenting and verifying that all equipment, utilities, facilities, and supporting systems are correctly installed and operational according to the manufacturer’s specifications and intended use. The key steps in IQ include:

- Verifying that equipment is correctly installed and located as per design specifications.

- Confirm that all required utilities (power, water, gases, etc.) are properly connected and functioning.

- Ensuring that calibration and maintenance schedules are in place for all equipment.

- Documenting all installation activities and results.

2. Operational Qualification (OQ):

OQ focuses on testing the equipment and processes to ensure that they operate within defined parameters and are capable of consistently producing the desired results. The main steps in OQ include:

- Defining the operating ranges and limits for critical process parameters.

- Conducting tests to demonstrate that equipment functions within specified parameters.

- Performing worst-case scenario testing to validate the process’s robustness.

- Collecting and analysing data to verify that equipment consistently meets specifications.

- Documenting all test protocols, results, and any deviations along with corrective actions taken.

3. Performance Qualification (PQ):

PQ demonstrates that the manufacturing process consistently produces products that meet all quality requirements and specifications. It involves testing the entire process using actual production materials and conditions. The key steps in PQ include:

- Conducting production runs using actual materials under normal operating conditions.

- Monitoring and collecting data throughout the production runs to ensure consistency.

- Analysing the data to confirm that the process consistently meets specifications.

- Addressing any deviations or out-of-spec results and implementing corrective actions.

- Documenting the entire PQ process, including protocols, data, and conclusions.

Throughout the IQ, OQ, and PQ stages, it’s essential to maintain thorough documentation of all activities, tests, results, and corrective actions. This documentation serves as evidence that the manufacturing process is validated and can consistently produce safe and effective medical devices.

Remember that the specific requirements and guidelines for process validation can vary based on the regulatory environment, the type of medical device, and the standards applicable in your region. It’s crucial to consult relevant regulatory guidelines (such as FDA’s Quality System Regulation or ISO 13485) and work closely with your quality and regulatory teams during the validation process.

IZiel’s Onshore-Offshore Model works with 1 Onsite Member supported by a team of 3–4 engineers from our Technical Center in India. Typically, the data is collected, evaluated and evidence is developed from the process design stage throughout production. Our Model enables the company to complete the project faster and in a cost-effective manner.