Operational Qualification Protocol for Cap Tightening Machine in Production/Packaging
Document Number: OQ-CTM-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Cap Tightening Machine operates within specified limits and meets the requirements outlined in the User Requirements Specification (URS) Annex 11.
Scope
This protocol applies to the Cap Tightening Machine used in the production and packaging of both sterile and non-sterile nasal and otic products.
Responsibilities
The Validation Team is responsible for executing this protocol, while the Quality Assurance team will oversee the review and approval process.
Prerequisites
- Installation Qualification (IQ) must be completed and approved.
- All personnel must be trained on the operation of the Cap Tightening Machine.
Equipment Description
The Cap Tightening Machine is designed to securely fasten caps onto containers for nasal and otic products, ensuring that the integrity of the product is maintained. It is equipped with torque reject logic audit trail logs to monitor performance and compliance.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-CTM-01 | Verify torque settings on the machine. | Torque settings must be within specified limits as per URS Annex 11. | Torque log reports. |
| OQ-CTM-02 | Validate the audit trail functionality. | Audit trail logs must capture all relevant data accurately. | Audit trail log review. |
| OQ-CTM-03 | Perform a simulated production run. | No caps should be rejected outside of the acceptable torque range. | Production run report. |
Detailed Test Cases
Test Case OQ-CTM-01
Procedure: Measure the torque applied by the Cap Tightening Machine using a calibrated torque wrench. Record the values.
Acceptance Criteria: Torque must be within the specified range as defined in URS Annex 11.
Evidence: Documented torque measurement results.
Test Case OQ-CTM-02
Procedure: Review the audit trail logs generated during operation to ensure all actions are recorded.
Acceptance Criteria: Audit trail must show no discrepancies and capture all operator actions.
Evidence: Audit trail log printouts.
Test Case OQ-CTM-03
Procedure: Conduct a production run with a defined number of samples and monitor the outputs.
Acceptance Criteria: All samples must pass the torque acceptance criteria without any rejections.
Evidence: Production run summary report.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. Corrective actions should be implemented as necessary, and re-testing may be required.
Approvals
Prepared by: ______________________
Title: _____________________________
Date: ______________________________
Reviewed by: ______________________
Title: _____________________________
Date: ______________________________