Validating Products/Processes (IQ, OQ, & PQ)
All products and processes need validation when you cannot verify the process output by monitoring or measuring. These validations are performed to reduce production costs and ensure regulatory requirements are met. IQ, OQ, and PQ are requirement-based methods that facilitate validating a process before it is placed within the target environment.
- Installation Qualification (IQ). IQ validation ensures that all equipment has been installed correctly. Evaluated parameters include: applicable inputs, environmental conditions, required calibrations, implemented safety measures, and proper documentation of maintenance practices.
- Operational Qualification (OQ). OQ validation verifies key performance components of a product or process without taking into consideration the cumulative effects introduced within the environment during testing. The goal is to demonstrate and document the product or process will function as the design intended (e. g., according to pre-defined specifications) once placed in the end-user's environment.
- Performance Qualification (PQ). PQ validation demonstrates and documents evidence that the product or process will consistently perform according to a predefined process specification, determined utilizing a detailed analysis of the end-user environment.
For example, in the medical community, the primary regulatory body is the FDA. Their Quality System Regulation, 21 CFR (Code of Federal Regulations) Part 820, requires all medical device manufacturers perform a detailed IQ/OQ/PQ validation to fully verify each process.