Design Qualification Protocol for Ophthalmic Compounding Vessel
Document Control
Document Number: DQ-OPH-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Ophthalmic Compounding Vessel meets the requirements set forth in the User Requirement Specification (URS) for the preparation of sterile ophthalmic bulk solutions and ointment bases.
Scope
This protocol applies to the design qualification of the Ophthalmic Compounding Vessel used in the production area for ophthalmic products, specifically sterile eye drops and eye ointments.
Responsibilities
The Validation Team is responsible for executing the DQ protocol, while the Quality Assurance (QA) department will oversee the review and approval processes.
Prerequisites
- Completion of User Requirement Specification (URS).
- Installation of the Ophthalmic Compounding Vessel.
- Training of personnel on equipment operation and validation processes.
Equipment Description
The Ophthalmic Compounding Vessel is a jacketed stainless steel vessel designed for the preparation of sterile ophthalmic bulk solutions and ointments. It features temperature control, agitation capabilities, and a PLC audit trail for data integrity.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-1 | Verify agitation functionality at specified settings. | Agitation meets specified RPM and time. | Calibration records, test logs. |
| DQ-2 | Confirm temperature hold time during operation. | Temperature maintained within specified range for required duration. | Temperature logs, PLC audit trail. |
| DQ-3 | Review PLC audit trail for data integrity. | Audit trail shows no gaps or errors. | Audit trail report. |
Detailed Test Cases
Test Case DQ-1
Objective: To verify the agitation functionality of the vessel.
Procedure: Set the agitation to specified RPM and time. Record the actual RPM and duration.
Acceptance Criteria: Agitation meets specified RPM and time.
Expected Outcome: The vessel should operate within set parameters without deviation.
Test Case DQ-2
Objective: To confirm temperature hold time.
Procedure: Monitor temperature during operation for the specified duration.
Acceptance Criteria: Temperature maintained within specified range.
Expected Outcome: Temperature logs show compliance with specified parameters.
Test Case DQ-3
Objective: To review the PLC audit trail for data integrity.
Procedure: Generate and review the PLC audit trail report.
Acceptance Criteria: No gaps or errors in the audit trail.
Expected Outcome: The audit trail report confirms data integrity.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Corrective actions should be implemented as necessary.
Approvals
The protocol must be signed and approved by the following individuals:
- Prepared By: ______________________
- Reviewed By: ______________________
- Approved By: ______________________