Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Operational Qualification Protocol for Suppository Base Melting Vessel
Objective: To validate the operational performance of the Suppository Base Melting Vessel (Jacketed SS) to ensure it meets specified requirements for melting PEG for suppository production.
Scope: This protocol applies to the operational qualification of the Suppository Base Melting Vessel used in the Production area for the melting of PEG, ensuring compliance with industry standards and product impact requirements.
Responsibilities:
- Validation Team: Execute the OQ protocol and document results.
- Quality Assurance: Review and approve the OQ documentation.
- Production Personnel: Assist in the execution of the protocol.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of necessary equipment and materials.
- Training of personnel on equipment operation.
Equipment Description:
The Suppository Base Melting Vessel (Jacketed SS) is designed to melt PEG for suppository production. It features a stainless steel jacket for controlled heating and is equipped with temperature control mechanisms to ensure uniform melting.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-01 | Verify temperature calibration | ±2°C of set point | Calibration certificate |
| OQ-02 | Check operational controls | All controls functional | Test report |
| OQ-03 | Perform melting test with PEG | Complete melting within 30 minutes | Melting time log |
Test Cases:
- Test ID: OQ-01
Procedure: Verify the calibration of the temperature gauge against a certified thermometer.
Acceptance Criteria: The temperature should be within ±2°C of the set point.
Evidence: Calibration certificate must be maintained in the validation file.
- Test ID: OQ-02
Procedure: Check all operational controls for functionality.
Acceptance Criteria: All controls must operate without error.
Evidence: A detailed test report documenting the results.
- Test ID: OQ-03
Procedure: Conduct a melting test using PEG, recording the time taken for complete melting.
Acceptance Criteria: The melting process should be completed within 30 minutes.
Evidence: Melting time log to be included in the final report.
Deviations:
Any deviations from the acceptance criteria must be documented in the deviation log and approved by the Quality Assurance team.
Approvals:
__________________________
Validation Team Lead
__________________________
Quality Assurance Manager
Data Integrity Checks:
- Ensure that all data logs are electronically signed and time-stamped.
- Perform regular backups of the temperature control data.
- Review data entries for accuracy and completeness.