Document Control Number: DQ-OTIC-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Design Qualification Protocol for Otic Drop Filling Machine
Objective
The objective of this Design Qualification (DQ) protocol is to establish documented evidence that the Otic Drop Filling Machine is designed and operates in accordance with user requirements, regulatory standards, and company policies.
Scope
This protocol applies to the validation of the Otic Drop Filling Machine used in the production of sterile and non-sterile ear drop bottles within the production area.
Responsibilities
The following roles are responsible for the execution of this DQ protocol:
- Validation Manager: Overall oversight and approval of the DQ protocol.
- Quality Assurance: Review and ensure compliance with regulatory requirements.
- Production Manager: Ensure the machine is operated according to the specifications during testing.
- Validation Engineer: Execute the tests and document the results.
Prerequisites
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) of the Otic Drop Filling Machine.
- Availability of qualified personnel for operation and testing.
Equipment Description
The Otic Drop Filling Machine is designed to fill ear drop bottles with precise volumes of liquid. It features advanced fill accuracy, reject logic, and an audit trail to ensure data integrity and compliance with regulatory standards.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify fill accuracy | Fill volume within ± 0.5% of target | Calibration records, test results |
| DQ-02 | Audit trail functionality | All actions logged with user ID and timestamp | Audit trail report |
| DQ-03 | Reject logic test | Rejects out-of-spec bottles correctly | Test run results |
Detailed Test Cases
Test Case DQ-01: Verify Fill Accuracy
Procedure: Perform fill tests using calibrated measuring devices. Record the volume filled in each test.
Acceptance Criteria: The fill volume must be within ± 0.5% of the target volume.
Evidence: Documented results and calibration certificates.
Test Case DQ-02: Audit Trail Functionality
Procedure: Simulate various user actions on the machine and verify that each action is logged in the audit trail.
Acceptance Criteria: Each action must be recorded with the correct user ID and timestamp.
Evidence: Printout of the audit trail report.
Test Case DQ-03: Reject Logic Test
Procedure: Fill a series of bottles, intentionally adjusting the fill volume to trigger the reject logic.
Acceptance Criteria: All out-of-spec bottles must be rejected by the system.
Evidence: Test run results showing rejection of out-of-spec bottles.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan must be initiated if critical deviations occur.
Approvals
Approval of this DQ protocol signifies agreement that the Otic Drop Filling Machine meets the necessary design qualifications for use in production.
Validation Manager: ____________________ Date: ___________
Quality Assurance: ____________________ Date: ___________
Production Manager: ____________________ Date: ___________