1. Purpose

To verify and document that the equipment/system performs consistently and reliably under actual production conditions as per predefined specifications and acceptance criteria.

2. Scope

This PQ is applicable to [Equipment/System Name] used in [Department/Process] at [Company Name].

3. Responsibility

• Quality Assurance (QA): Review and approval of PQ protocol and report.

• User Department: Execution of PQ and documentation.

• Engineering: Support during qualification.

4. Procedure

1. Pre-requisites

   • Ensure completion of Installation Qualification (IQ) and Operational Qualification (OQ).

   • Ensure calibration and validation of critical instruments.

   • Train personnel involved in PQ execution.

2. Execution

   • Define critical process parameters and operating ranges.

   • Run the equipment under normal production conditions.

   • Perform minimum three (3) successful production runs/batches.

   • Record performance data (temperature, pressure, RPM, cycle time, yield, etc. as applicable).

   • Conduct in-process and finished product testing as per specifications.

3. Acceptance Criteria

   • Equipment must consistently perform within defined parameters.

   • Product quality must comply with predetermined specifications.

   • No significant deviation should occur during PQ runs.

4. Deviation Handling

   • Document any deviations and investigate root cause.

   • Implement corrective/preventive actions (CAPA) if required.

5. Documentation

   • PQ protocol (approved before execution).

   • Raw data, test results, and batch records.

   • PQ report (summarizing execution, results, and conclusion).

5. Conclusion

PQ ensures that the equipment/system consistently performs as intended and is suitable for routine use in production.