Document ID: OQ-TP-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approved By: [Name]
Operational Qualification Protocol for Bilayer/Multilayer Tablet Press
Objective: To establish and document the operational qualification of the bilayer/multilayer tablet press to ensure it operates within specified limits and meets the requirements outlined in the User Requirement Specification (URS) Annex 11.
Scope: This protocol applies to the operational qualification of the bilayer/multilayer tablet press located in the production/compression area, specifically for the manufacture of multilayer tablets.
Responsibilities:
- Validation Team: Execute the qualification activities and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Personnel: Provide operational support and assist with data collection.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of necessary materials and resources.
- Training of personnel on equipment operation.
Equipment Description:
The bilayer/multilayer tablet press is designed for the production of multilayer tablets. It features programmable logic control (PLC) for monitoring and controlling critical parameters such as layer weight, control force, and profile.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-TP-01 | Verify layer weight control settings. | Layer weight within ±5% of target. | Weight measurement log. |
| OQ-TP-02 | Test control force profile. | Control force within specified range. | Control force data report. |
| OQ-TP-03 | Validate PLC functionality. | PLC operates without errors. | PLC operational report. |
Detailed Test Cases:
- Test Case OQ-TP-01: Measure and record the layer weight of 10 tablets. Ensure all measurements are within ±5% of the target weight.
- Test Case OQ-TP-02: Monitor the control force during the compression of tablets. Document the profile to ensure it remains within specified limits.
- Test Case OQ-TP-03: Conduct a functionality test on the PLC by simulating an operational cycle. Confirm that all alerts and functions operate correctly.
Deviations:
Any deviations from the acceptance criteria must be documented and justified. A corrective action plan should be developed to address any critical failures.
Approvals:
Prepared By: ____________________ Date: ___________
Reviewed By: ____________________ Date: ___________
Approved By: ____________________ Date: ___________
Data Integrity Checks:
- Ensure all data is logged in real-time during the qualification process.
- Implement user access controls to prevent unauthorized alterations to data.
- Conduct routine audits of data logs to ensure compliance with validation protocols.