Document Control Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Stoppering Machine in IV Infusions Production
Objective: To validate the operational performance of the Stoppering Machine used in the production of IV Infusions, ensuring placement accuracy, reject logic, and audit trail functionality meet specified acceptance criteria.
Scope: This protocol applies to the Stoppering Machine utilized in the production area for placing stoppers on IV infusion bags and bottles, impacting product quality directly.
Responsibilities:
- Validation Team: Responsible for conducting the OQ tests and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Production Personnel: Responsible for operating the equipment during testing and ensuring adherence to the protocol.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Training of personnel on the Stoppering Machine operation.
- Availability of all necessary tools and materials for testing.
Equipment Description: The Stoppering Machine is designed for placing stoppers on IV infusion bags and bottles. It operates within specified parameters to ensure critical quality attributes are met.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify placement accuracy of stoppers. | Placement accuracy within ±0.5 mm. | Measurement logs and photographs. |
| OQ-02 | Test reject logic functionality. | Reject logic activates for out-of-spec stoppers. | Test logs and equipment alerts. |
| OQ-03 | Check audit trail recording. | Audit trail must capture all relevant actions. | Audit trail printouts. |
Detailed Test Cases:
- Test Case OQ-01: Measure the placement accuracy of stoppers using calipers. Record measurements and compare against acceptance criteria.
- Test Case OQ-02: Simulate a failure condition and verify that the reject logic activates properly, preventing non-conforming products.
- Test Case OQ-03: Review the audit trail generated during the test to ensure all actions are recorded accurately and completely.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed if necessary.
Approvals:
- Validation Team Lead: _______________________ Date: __________
- Quality Assurance Manager: __________________ Date: __________
Data Integrity Checks: During the OQ, ensure that:
- Data entered into the system is validated against expected results.
- Audit trails are reviewed for anomalies.
- Backup procedures for data are in place and tested.