Document Control Number: OQ-CCIT-001
Version: 1.0
Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Operational Qualification Protocol for CCIT System in Ophthalmics
Objective: To validate the CCIT System for ensuring container closure integrity of sterile eye drops and eye ointments.
Scope: This protocol applies to the Operational Qualification of the CCIT System used in the QC/Production area for ophthalmic products.
Responsibilities:
- Validation Team: Prepare and execute the OQ protocol.
- Quality Assurance: Review and approve the OQ protocol and results.
- Production Team: Provide necessary equipment and support during testing.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Training of personnel on the CCIT System.
- Availability of all necessary materials and equipment.
Equipment Description:
The CCIT System is designed for the assessment of container closure integrity through vacuum decay, helium, and high vacuum leak detection methods. It ensures the integrity of containers used for sterile ophthalmic products.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Conduct leak rate sensitivity audit trail. | Leak rate must not exceed limits specified in URS Annex11. | Audit trail report. |
| OQ-002 | Verify system calibration. | Calibration must be within specified ranges. | Calibration certificate. |
| OQ-003 | Perform system functionality test. | System must operate without errors. | Test run report. |
Detailed Test Cases:
- Test Case OQ-001:
Perform a leak rate sensitivity audit trail using predetermined standards. Document all findings in the audit trail report.
- Test Case OQ-002:
Verify the calibration of the CCIT System. Ensure that the calibration is within the acceptable ranges as per manufacturer specifications.
- Test Case OQ-003:
Execute a functionality test of the CCIT System to ensure proper operation. Document any errors or malfunctions encountered during the test.
Deviations:
Any deviations from the protocol must be documented and justified. Approval from Quality Assurance is required for any deviations.
Approvals:
Prepared by: ______________________ Date: ___________
Approved by: ______________________ Date: ___________
Data Integrity Checks:
- Ensure audit trails are enabled and reviewed post-testing.
- Verify that data is backed up and securely stored.
- Confirm that all entries are time-stamped and attributed to the respective user.