Document Control Number: PQ-OSD-CAP-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Screw Cap Equipment
Objective: To validate the performance of the Screw Cap equipment used for capping bottles in the packaging area, ensuring compliance with specified acceptance criteria.
Scope: This protocol applies to the Performance Qualification (PQ) of the Screw Cap equipment utilized in the Solid Dosage Form (OSD) packaging process.
Responsibilities:
- Validation Team: Execute the PQ protocol and document results.
- Quality Assurance: Review and approve the PQ documentation.
- Maintenance Team: Ensure the equipment is operational prior to testing.
Prerequisites:
- Installation Qualification (IQ) and Operational Qualification (OQ) must be completed and approved.
- Personnel must be trained on equipment operation and validation procedures.
Equipment Description:
The Screw Cap equipment is designed to cap bottles in the packaging area, ensuring a secure seal. It operates within specified torque ranges and includes reject sensors for quality assurance.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Verify torque range during operation | Torque must be within specified limits as per URS Annex11 | Torque measurement logs |
| PQ-002 | Test speed settings | Speed must meet operational specifications | Speed calibration records |
| PQ-003 | Audit trail verification | All actions must be recorded in the system audit trail | Audit trail report |
| PQ-004 | Reject sensor functionality test | Reject sensors must activate correctly | Sensor test results |
Detailed Test Cases:
Test Case PQ-001: Verify torque range during operation.
- Procedure: Operate the machine and measure the torque applied.
- Expected Result: Torque should be within the defined range.
Test Case PQ-002: Test speed settings.
- Procedure: Adjust speed settings and measure output.
- Expected Result: Speed should match specifications.
Test Case PQ-003: Audit trail verification.
- Procedure: Review the audit trail for completeness.
- Expected Result: All actions should be logged without gaps.
Test Case PQ-004: Reject sensor functionality test.
- Procedure: Activate reject sensors and verify response.
- Expected Result: Sensors should function as intended.
Deviations:
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan must be established if deviations occur.
Approvals:
Prepared by: ______________________ Date: ____________
Reviewed by: ______________________ Date: ____________
Approved by: ______________________ Date: ____________
Data Integrity Checks:
- Ensure all data entries are time-stamped and user-identified.
- Regularly back up audit trail data to prevent loss.
- Implement access controls to restrict unauthorized changes.