Document Control Number: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Prepared By: [Your Name]
Reviewed By: [Reviewer Name]
Approval Date: [Approval Date]
Design Qualification Protocol for Aseptic Filling Machine Used in IV Infusions
Objective
The objective of this Design Qualification (DQ) protocol is to establish documented evidence that the Aseptic Filling Machine for IV Bottles is capable of consistently operating within the defined parameters to produce sterile products.
Scope
This protocol applies to the Aseptic Filling Machine used in the production area for filling sterile IV bottles. It covers all aspects of the equipment’s operation, including critical parameters and compliance with regulatory requirements.
Responsibilities
- Validation Team: Responsible for the execution and documentation of the DQ protocol.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and reports.
- Production Team: Responsible for operating the equipment as per established procedures.
Prerequisites
- Equipment installation completed and verified.
- Standard Operating Procedures (SOPs) for operation and maintenance available.
- Training completed for all personnel involved in the operation of the Aseptic Filling Machine.
Equipment Description
The Aseptic Filling Machine is designed for the sterile filling of IV bottles. It operates under controlled conditions to ensure the integrity of the filled product. The machine includes features for fill volume accuracy, stopper/cap placement, and an audit trail for rejects.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify fill volume accuracy | Within ± 5% of target volume | Calibration records, test results |
| DQ-02 | Check stopper/cap placement | 100% correct placement | Visual inspection records |
| DQ-03 | Review reject audit trail | No unresolved rejects | Audit trail report |
Detailed Test Cases
Test Case DQ-01: Verify Fill Volume Accuracy
Objective: To ensure the filling machine dispenses the correct volume of liquid into the bottles.
Procedure: Conduct a series of fill tests using calibrated measuring devices to verify the fill volume.
Acceptance Criteria: The fill volume must be within ± 5% of the target volume.
Evidence: Documented test results and calibration records.
Test Case DQ-02: Check Stopper/Cap Placement
Objective: To confirm that stoppers and caps are placed correctly on the filled bottles.
Procedure: Perform a visual inspection of a sample of filled bottles to verify stopper and cap placement.
Acceptance Criteria: 100% of inspected bottles must have correct placement.
Evidence: Inspection records and photographs.
Test Case DQ-03: Review Reject Audit Trail
Objective: To ensure that all rejects are documented and addressed appropriately.
Procedure: Review the audit trail generated by the filling machine for any rejected bottles.
Acceptance Criteria: There must be no unresolved rejects in the audit trail.
Evidence: Audit trail report and corrective action records.
Deviations
Any deviations from the acceptance criteria must be documented and justified. A root cause analysis should be conducted, and corrective actions must be implemented.
Approvals
Prepared By: ______________________
Reviewed By: ______________________
Approved By: ______________________
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