Performance Qualification Protocol for Cap Tightening / Capping Machine in Ophthalmics Production
Document Number: PQ-CTCM-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to ensure that the Cap Tightening / Capping Machine operates consistently and reliably within predefined specifications to meet the requirements for the production of sterile eye drops and ointments.
Scope
This protocol applies to the Cap Tightening / Capping Machine used in the production area for the capping of sterile eye drops and ointments. It covers the validation of critical parameters affecting 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.
- Production Team: Responsible for operating the equipment as per the validated procedures.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary materials and equipment for testing.
- Training of personnel on the operation of the Cap Tightening / Capping Machine.
Equipment Description
The Cap Tightening / Capping Machine is designed to securely cap bottles containing sterile eye drops and ointments. The machine features adjustable torque settings to ensure proper sealing and prevent contamination.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify torque range settings | Torque range within specified limits | Calibration report |
| PQ-02 | Audit trail review | No discrepancies in audit trail | Audit trail logs |
| PQ-03 | Reject logic functionality test | Machine rejects improperly capped bottles | Test run records |
Detailed Test Cases
Test Case 1: Verify Torque Range Settings
Objective: To ensure the torque settings are within the specified limits.
Procedure: Set the machine to the specified torque range and measure using a torque gauge.
Acceptance Criteria: Torque range must be within limits defined in the URS Annex11.
Evidence: Record the torque measurements and compare with acceptance criteria.
Test Case 2: Audit Trail Review
Objective: To confirm that the machine maintains a complete and accurate audit trail.
Procedure: Access the machine’s audit trail and review for discrepancies.
Acceptance Criteria: No discrepancies should be present in the audit trail.
Evidence: Document any findings and ensure they are addressed.
Test Case 3: Reject Logic Functionality Test
Objective: To verify that the reject logic functions correctly.
Procedure: Run a series of capping tests with intentional errors and confirm rejection.
Acceptance Criteria: The machine must reject all improperly capped bottles.
Evidence: Collect data from test runs and document outcomes.
Deviations
Any deviations from the protocol must be documented and justified. A deviation report should be completed and submitted for review by Quality Assurance.
Approvals
Prepared by: ____________________ Date: ____________
Approved by: ____________________ Date: ____________