Document Number: DQ-001
Version: 1.0
Date: 2023-10-01
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Design Qualification Protocol for SIP System in Prefilled Syringes & Cartridges
Objective: The objective of this Design Qualification (DQ) protocol is to ensure that the SIP System utilized in the production of prefilled syringes and cartridges meets the specified requirements for sterilization of equipment and pipelines.
Scope: This protocol covers the validation of the SIP System within the production area, focusing on its capability to sterilize equipment and pipelines directly impacting product quality.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Review and approve the DQ protocol and results.
- Production Team: Provide operational support during the validation process.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) of the SIP System.
- Availability of necessary documentation and resources for validation.
Equipment Description: The SIP System is designed to sterilize equipment and pipelines used in the production of prefilled syringes and cartridges. It operates under controlled temperature and pressure conditions, with an audit trail for process monitoring.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001-T1 | Verify temperature settings | Temperature must be within specified range | Calibration logs, temperature records |
| DQ-001-T2 | Verify pressure settings | Pressure must be within specified range | Calibration logs, pressure records |
| DQ-001-T3 | Check hold time | Hold time must meet URS Annex 15 requirements | Audit trail logs |
Detailed Test Cases:
- Test Case 1: Confirm that the SIP System maintains the required temperature throughout the sterilization cycle. Document the temperature logs for review.
- Test Case 2: Confirm that the SIP System maintains the required pressure throughout the sterilization cycle. Document the pressure logs for review.
- Test Case 3: Verify the hold time during the sterilization cycle is consistent with URS Annex 15. Review audit trail logs for compliance.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan should be initiated for any significant deviations.
Approvals:
- Prepared By: ______________________
- Reviewed By: ______________________
- Approved By: ______________________
Data Integrity Checks: Ensure that all data generated during the validation process is securely stored and that access is restricted to authorized personnel. Regular backups and audits of data integrity should be performed to maintain compliance.