Document Control Number: OQ-001
Version: 1.0
Date: 2023-10-01
Prepared by: [Name]
Approved by: [Name]
Operational Qualification Protocol for Capsule Metal Detector
Objective: To establish the operational qualification of the Capsule Metal Detector to ensure it meets specified requirements for detecting metal contaminants in solid dosage forms.
Scope: This protocol applies to the Capsule Metal Detector used in the Production area for capsules. It includes testing of the equipment’s functionality and performance to ensure compliance with the User Requirement Specification (URS) Annex 11.
Responsibilities:
- Validation Team: Execute and document the qualification activities.
- Quality Assurance: Review and approve the protocol and results.
- Production Personnel: Operate the equipment as per the validated procedures.
Prerequisites:
- Installation Qualification (IQ) must be completed.
- Staff must be trained on the operation of the Capsule Metal Detector.
Equipment Description:
The Capsule Metal Detector is designed to detect metal contaminants in capsules during production. It operates using advanced sensitivity settings to identify ferrous and non-ferrous metals, ensuring product integrity and safety.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Sensitivity reject verification | Must reject all test metal samples | Test results log |
| OQ-02 | Audit trail verification | Complete audit trail for all operations | Audit trail report |
Detailed Test Cases:
- Test Case OQ-01:
Procedure: Introduce known metal contaminants to the detector and verify rejection.
Acceptance Criteria: All contaminants must be rejected.
Evidence: Documented results of each test and observations.
- Test Case OQ-02:
Procedure: Review the audit trail for completeness and accuracy.
Acceptance Criteria: No gaps or missing entries in the audit trail.
Evidence: Audit trail report showing all operations performed.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be conducted, and appropriate corrective actions must be implemented.
Approvals:
Prepared by: ____________________ Date: ___________
Approved by: ____________________ Date: ___________
Data Integrity Checks:
- Ensure all data entries are time-stamped and user-identified.
- Regular audits of the CSV for accuracy and completeness.
- Backup of data logs to prevent loss.