IQ, OQ, PQ — A Guide to Process Validation

Process Validation is conducted to ensure consistent delivery of quality products meeting its predetermined specifications/requirements and quality characteristics. This enables to ensure the complete safety & efficacy of medical devices.

• Installation Qualification (IQ) — Installation qualification is used to ensure that the installation of any necessary equipment, piping, services, or instrumentation has been executed in accordance with the manufacturer’s requirements.
• Operational Qualification (OQ) — During operational qualification, the equipment should be tested to determine process control limits, potential failure modes, action levels, and worst-case scenarios.
• Performance Qualification (PQ) — In the performance qualification phase, the goal is to demonstrate that the process will consistently produce acceptable results under normal operating conditions.

When do you use IQ, OQ and PQ?

Asked below mentioned questions to get the answer.

IQ — Is everything installed correctly?

OQ — Is everything operating correctly? & What are the operating limitations of the device?

PQ — Does this process produces the right results? & Is the process safe and consistent?

IZiel provides complete expertise in process validation and assists medical device manufacturers to consistently meet required parameters through their optimized manufacturing 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, and 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.