Document Control: DQ-001
Version: 1.0
Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Design Qualification Protocol for SIP System in Ophthalmics Production
Objective: To validate the SIP System used in the production and sterilization of ophthalmic products, ensuring compliance with regulatory requirements and product quality standards.
Scope: This protocol applies to the SIP System (Tanks/Lines) used in the production area for sterilizing vessels and lines directly impacting product quality.
Responsibilities:
- Validation Team: Develop and execute the DQ protocol.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide necessary operational support and data.
Prerequisites:
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) and Operational Qualification (OQ) completed.
- Availability of necessary documentation and equipment.
Equipment Description: The SIP System consists of tanks and lines designed to sterilize vessels and lines through controlled temperature, pressure, and hold time parameters. This system is critical for ensuring the sterility of ophthalmic products.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001-01 | Verify temperature settings during sterilization cycle. | Temperature maintained within specified range as per URS Annex 15. | Temperature logs. |
| DQ-001-02 | Verify pressure settings during sterilization cycle. | Pressure maintained within specified range as per URS Annex 15. | Pressure logs. |
| DQ-001-03 | Verify hold time during sterilization cycle. | Hold time meets specified duration as per URS Annex 15. | Hold time logs. |
Detailed Test Cases:
- Test Case 1: Monitor and record temperature during the sterilization cycle. Ensure that temperature remains within the specified limits for the entire cycle.
- Test Case 2: Monitor and record pressure during the sterilization cycle. Ensure that pressure remains constant and within the specified limits.
- Test Case 3: Monitor and record the hold time. Ensure that the specified hold time is achieved and maintained.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A root cause analysis should be performed, and appropriate corrective actions taken.
Approvals:
- Prepared by: ____________________ Date: ___________
- Reviewed by: ____________________ Date: ___________
- Approved by: ____________________ Date: ___________
Data Integrity Checks: Ensure that all data recorded during the validation process is accurate, complete, and securely stored. Regular audits and reviews should be conducted to maintain data integrity.