Document Number: PQ-OSP-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed by: [Name]
Approved by: [Name]
Performance Qualification Protocol for Strip Packing Machine
Objective: To establish the performance qualification of the strip packing machine used in the packaging of solid dosage forms, ensuring it meets the defined acceptance criteria and operates within specified parameters.
Scope: This protocol applies to the validation of the strip packing machine located in the packaging area for solid dosage forms. It covers the assessment of critical parameters that impact product quality.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Engineering: Responsible for maintaining the equipment and ensuring it operates within specifications.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- Operational Qualification (OQ) must be completed and approved.
- All personnel involved in the validation must be trained on the equipment and procedures.
Equipment Description:
The strip packing machine is designed for the packaging of solid dosage forms into strip packs. It operates under controlled parameters to ensure product integrity and compliance with regulatory standards.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-001 | Verify sealing temperature settings | Within specified range as per URS Annex11 | Calibration records |
| PQ-002 | Measure dwell time during sealing | As per URS Annex11 | Test run data |
| PQ-003 | Check pressure during sealing | Within specified range as per URS Annex11 | Pressure gauge readings |
| PQ-004 | Assess registration accuracy | Within acceptable limits as per URS Annex11 | Visual inspection records |
| PQ-005 | Evaluate reject rate during operation | Less than 2% as per URS Annex11 | Production logs |
Detailed Test Cases:
Test Case PQ-001: Verify sealing temperature settings.
- Procedure: Set the machine to the specified sealing temperature and record the actual temperature.
- Acceptance Criteria: The temperature must be within the specified range as per URS Annex11.
- Evidence: Calibration records and machine log.
Test Case PQ-002: Measure dwell time during sealing.
- Procedure: Run the machine and measure the time the seal is applied.
- Acceptance Criteria: Dwell time must be as per URS Annex11.
- Evidence: Test run data.
Test Case PQ-003: Check pressure during sealing.
- Procedure: Monitor the pressure gauge during the sealing process.
- Acceptance Criteria: Pressure must be within specified range as per URS Annex11.
- Evidence: Pressure gauge readings.
Test Case PQ-004: Assess registration accuracy.
- Procedure: Perform a visual inspection of the strip packs for registration alignment.
- Acceptance Criteria: Registration must be within acceptable limits as per URS Annex11.
- Evidence: Visual inspection records.
Test Case PQ-005: Evaluate reject rate during operation.
- Procedure: Record the number of rejects during a production run.
- Acceptance Criteria: Reject rate must be less than 2% as per URS Annex11.
- Evidence: Production logs.
Deviations:
Any deviations from the acceptance criteria must be documented, including the rationale for the deviation and the impact on product quality.
Approvals:
All results from the performance qualification must be reviewed and approved by the Quality Assurance team before the equipment can be released for routine production.