Document Control
Document Number: OQ-SSM-001
Version: 1.0
Effective Date: [Insert Date]
Prepared by: [Insert Name]
Reviewed by: [Insert Name]
Approved by: [Insert Name]
Operational Qualification Protocol for Syringe Stoppering Machine
Objective: To validate the operational performance of the Syringe Stoppering Machine to ensure it meets the specified requirements for stopper placement in prefilled syringes.
Scope: This protocol applies to the Syringe Stoppering Machine located in the Production area, used for inserting stoppers into prefilled syringes and cartridges.
Responsibilities:
- Validation Team: Responsible for executing the protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Personnel: Responsible for operating the equipment during testing.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Training of personnel on equipment operation.
- Availability of necessary materials (syringes, stoppers, etc.).
Equipment Description:
The Syringe Stoppering Machine is designed to insert stoppers into prefilled syringes with a focus on precision and reliability. The machine includes features for monitoring stopper placement and maintaining an audit trail of reject logic.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Verify stopper placement accuracy. | 100% of stoppers must be placed correctly. | Measurement logs and visual inspection reports. |
| OQ-002 | Audit trail log verification. | All reject logic must be logged and accessible. | Audit trail logs from the machine. |
Detailed Test Cases
Test Case OQ-001:
- Objective: To confirm the accuracy of stopper placement.
- Procedure: Run the machine with a batch of 100 syringes. Measure the placement of each stopper.
- Expected Result: All stoppers are placed within specified tolerances.
- Actual Result: [To be filled during testing]
Test Case OQ-002:
- Objective: To ensure the audit trail logs all reject logic.
- Procedure: Operate the machine under conditions that trigger reject logic. Review the audit trail.
- Expected Result: All reject events are recorded in the audit trail.
- Actual Result: [To be filled during testing]
Deviations
Any deviations from the protocol must be documented and approved by Quality Assurance prior to proceeding with the testing.
Approvals
Prepared by: ___________________ Date: ___________
Reviewed by: ___________________ Date: ___________
Approved by: ___________________ Date: ___________
Data Integrity Checks
During this stage, the following data integrity checks will be implemented:
- Automated backup of audit trail logs after each batch run.
- Regular review of logs to ensure no unauthorized changes.
- Validation of data input methods to prevent data entry errors.