Document Control Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for Sterile Powder Filling Machine
Objective: To establish a Design Qualification (DQ) protocol for the Sterile Powder Filling Machine, ensuring it meets the requirements for filling sterile solutions into vials prior to lyophilization.
Scope: This protocol applies to the validation of the Sterile Powder Filling Machine used in the production area for sterile powders and lyophilized products.
Responsibilities:
- Validation Team: Preparation and execution of the DQ protocol.
- Quality Assurance: Review and approval of the DQ protocol.
- Production Personnel: Operation of the Sterile Powder Filling Machine.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) must be completed prior to DQ.
- Availability of necessary documentation and training for personnel.
Equipment Description: The Sterile Powder Filling Machine is designed to fill sterile solutions into vials with a focus on maintaining sterility and ensuring fill accuracy. The equipment includes features such as reject logic and an audit trail for critical parameters.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-001-01 | Verify fill accuracy using calibrated weights. | Fill accuracy within ±5% of target volume. | Calibration records, weight logs. |
| DQ-001-02 | Review reject logic functionality. | Reject logic activates for out-of-spec fills. | Audit trail logs, observation records. |
| DQ-001-03 | Audit trail verification. | Complete audit trail for all filling operations. | Audit trail report. |
Detailed Test Cases:
- Test Case 1: Fill accuracy test with 100 vials, measuring each fill weight.
- Test Case 2: Simulate out-of-spec fill and verify reject logic response.
- Test Case 3: Review audit trail for completeness and accuracy.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. Appropriate corrective actions should be taken.
Approvals:
- Prepared By: ______________________
- Reviewed By: ______________________
- Approved By: ______________________
Data Integrity Checks: Ensure that all data entered into the system is validated with user access controls, and that audit trails are regularly reviewed for compliance with CSV requirements.