Document Number: PQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Performance Qualification Protocol for Raw Material Sampling Booth
Objective: The objective of this Performance Qualification (PQ) protocol is to verify that the Raw Material Sampling Booth operates within defined parameters to ensure the quality and safety of API raw materials and intermediates.
Scope: This protocol applies to the Raw Material Sampling Booth located in the Warehouse/Sampling area used for sampling API raw materials and intermediates, impacting product quality directly.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Operations: Responsible for ensuring the equipment is maintained and calibrated as per the schedule.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- Operational Qualification (OQ) must be completed and approved.
- All necessary materials and personnel must be available for testing.
Equipment Description: The Raw Material Sampling Booth is designed to provide a controlled environment for sampling API raw materials and intermediates. It features HEPA filtration, air velocity monitoring, and differential pressure (DP) alarms to ensure compliance with cleanliness standards.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Measure air velocity at various points within the booth. | Air velocity must be within 0.45 m/s to 0.60 m/s. | Velocity measurement logs. |
| PQ-002 | Perform HEPA filter integrity test. | HEPA filter integrity must pass as per ISO14644 Annex 15. | HEPA integrity test report. |
| PQ-003 | Test differential pressure alarms functionality. | DP alarms must activate at specified thresholds. | Alarm test logs. |
Detailed Test Cases:
- Test Case 1: Verify air velocity by using an anemometer at specified locations within the booth.
- Test Case 2: Conduct a HEPA filter integrity test using a suitable aerosol challenge method.
- Test Case 3: Simulate a differential pressure failure to confirm alarm activation.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan must be developed and implemented.
Approvals:
- Prepared By: [Name]
- Reviewed By: [Name]
- Approved By: [Name]