SOP on Performance Qualification

1.0 Objective: To determine and demonstrate that the equipment performance consistently meets pre-determined specifications under normal conditions, and where appropriate for worst case situations.

2.0 Scope: performance qualification is done after installation, modification or relocation and for re-validation at appropriate intervals.

3.0 Responsibilities: Quality Assurance staff is responsible to perform the performance qualification and record the information..

1. SOPs for normal operations of the equipment.

2. SOPs specific for performance tests.

5.1 Run normal procedure three times for each use and record all required data and any deviations to the procedure.

5.2 Attach all completed, signed data record forms.

5.3 Complete the summary data record form.

5.4 Perform all required calculations and statistical analyses.

5.5 Compare to acceptance criteria.

5.6 Prepare deviation report including the justification of acceptance and impact on the performance.

5.7 Prepare a performance qualification report.