Document Number: OQ-EDFM-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Operational Qualification Protocol for Otic Drop Filling Machine
Objective
The objective of this Operational Qualification (OQ) protocol is to ensure that the Otic Drop Filling Machine operates according to the specified parameters and meets the acceptance criteria defined in the User Requirement Specification (URS) Annex 11.
Scope
This protocol applies to the Otic Drop Filling Machine used in the production area for filling ear drop bottles with sterile and non-sterile products.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and addressing any deviations. The Quality Assurance (QA) team will review and approve the protocol and its results.
Prerequisites
- Installation Qualification (IQ) must be completed and approved.
- All relevant personnel must be trained on the equipment and the protocol.
- Necessary materials and resources must be available and verified.
Equipment Description
The Otic Drop Filling Machine is designed to fill ear drop bottles with precision. It features automated filling, adjustable fill volumes, and a reject logic system for quality assurance. The machine is critical for ensuring the accuracy and integrity of the product during the filling process.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify fill accuracy | Fill volume within ±0.1 mL of target | Calibration report, filled bottle measurements |
| OQ-02 | Audit reject logic | Reject logic activates for out-of-spec fills | Audit trail report |
| OQ-03 | Validate audit trail | Audit trail must capture all fill events | Audit trail log review |
Detailed Test Cases
Test Case OQ-01: Verify Fill Accuracy
Procedure: Fill a series of bottles with a specified target volume and measure each fill.
Acceptance Criteria: All filled bottles must be within ±0.1 mL of the target volume.
Evidence: Document the measurements and compare against target values.
Test Case OQ-02: Audit Reject Logic
Procedure: Simulate a filling error and observe if the reject logic activates.
Acceptance Criteria: The machine must reject any fill that is out of specification.
Evidence: Review the audit trail for evidence of the reject logic activation.
Test Case OQ-03: Validate Audit Trail
Procedure: Review the audit trail generated during filling operations.
Acceptance Criteria: The audit trail must include timestamps, operator ID, and fill volume for each event.
Evidence: Provide a copy of the audit trail log.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions should be implemented as necessary.
Approvals
This protocol must be approved by the Validation Manager and the Quality Assurance Manager prior to execution.