OQ validation, or Operational Qualification, verifies that equipment performs consistently within manufacturer-specified operating ranges and according to user requirement specifications. It is performed after successfully completing Installation Qualification (IQ).
In essence, OQ answers the question: "Does the equipment operate as intended within the defined operating parameters?"
Here's a breakdown of OQ validation:
- Purpose: According to the provided reference, the core purpose of OQ is "to determine that equipment performance is consistent with the user requirement specification within the manufacturer-specified operating ranges."
- Timing: OQ takes place after the Installation Qualification (IQ) has been successfully completed.
- Focus: OQ focuses on verifying the equipment's functionality across its entire operating range, not just at a single set point. This ensures reliability and consistent performance under varying conditions.
Here's a simple table to illustrate the place of OQ in the validation process:
| Qualification Stage | Focus | Question Answered |
|---|---|---|
| Installation (IQ) | Correct installation of equipment and its components. | Is the equipment correctly installed? |
| Operational (OQ) | Equipment performance within specified operating ranges. | Does the equipment operate as intended within defined parameters? |
| Performance (PQ) | Consistent performance of the equipment in the actual production environment. | Does the equipment consistently perform in its intended environment? |
In short, OQ validation ensures the equipment's operational capabilities meet pre-defined requirements.
