Document Number: OQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Operational Qualification Protocol for Safety Device Assembly Machine
This document outlines the operational qualification (OQ) protocol for the Safety Device Assembly Machine used in the production of prefilled syringes and cartridges.
Objective: To validate the operational performance of the Safety Device Assembly Machine to ensure it meets the specified requirements for attaching safety devices to prefilled syringes and cartridges.
Scope: This protocol applies to the Safety Device Assembly Machine located in the Production area and is intended for use in the assembly of safety devices for prefilled syringes and cartridges.
Responsibilities:
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Production Team: Responsible for providing support during OQ execution.
Prerequisites:
- Completion of Installation Qualification (IQ) for the Safety Device Assembly Machine.
- Availability of necessary documentation (URS, SOPs, etc.).
- Training of personnel on the operation of the equipment.
Equipment Description:
The Safety Device Assembly Machine is designed to attach safety devices to prefilled syringes and cartridges. It operates using automated mechanisms to ensure precision and efficiency in the assembly process.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-01 | Verify assembly accuracy through audit trail logs. | 100% accuracy in assembly as per URS Annex11. | Audit trail log report. |
| OQ-02 | Conduct functional tests of the assembly process. | All functions operate within specified parameters. | Functional test report. |
Test Cases:
- Test Case OQ-01: Review the audit trail logs for assembly accuracy. All entries must reflect correct assembly operations.
- Test Case OQ-02: Perform a series of functional tests to ensure the machine operates correctly. Document any deviations from expected results.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed to address the root cause of the deviation.
Approvals:
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Validation Team Lead
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Quality Assurance
Data Integrity Checks:
- Regular backups of audit trail logs.
- Access controls to restrict unauthorized modifications.
- Periodic review of log entries for anomalies.