Design Qualification Protocol for CCIT System in Ophthalmics
Document Number: DQ-CCIT-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Design Qualification (DQ) protocol is to verify that the CCIT System (Vacuum Decay/Helium/HVLD) meets the specified requirements for container closure integrity in the production of sterile ophthalmic products.
Scope
This protocol applies to the CCIT System used in the QC/Production area for the validation of container closure integrity for sterile eye drops and eye ointments. The focus is on ensuring compliance with regulatory standards and internal quality requirements.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Equipment Owner: Responsible for providing access to the CCIT System and ensuring its availability for testing.
Prerequisites
- Completion of User Requirement Specification (URS) as per Annex 11.
- Installation of the CCIT System in compliance with manufacturer specifications.
- Training of personnel on the CCIT System operation.
Equipment Description
The CCIT System (Vacuum Decay/Helium/HVLD) is an instrument designed to assess the integrity of container closures for sterile products. It utilizes vacuum decay and helium leak detection methods to ensure the absence of leaks that could compromise product sterility.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Perform leak rate sensitivity audit trail. | Leak rate must not exceed specified limits as per URS Annex 11. | Audit trail report. |
| T2 | Verify calibration of the CCIT System. | Calibration certificate must be within valid date range. | Calibration log. |
Detailed Test Cases
Test Case T1: Leak Rate Sensitivity Audit Trail
1. Ensure the CCIT System is calibrated and operational.
2. Conduct a series of tests using known leak standards.
3. Document the results in the audit trail report.
4. Confirm that the leak rate does not exceed the specified limits.
Test Case T2: Calibration Verification
1. Retrieve the calibration certificate for the CCIT System.
2. Verify that the calibration is performed by an approved vendor.
3. Ensure that the calibration date is within the acceptable range.
Deviations
Any deviations from the established protocol must be documented and justified. A deviation report should be prepared and reviewed by Quality Assurance.
Approvals
This Design Qualification Protocol must be approved by the Validation Team and Quality Assurance before implementation.