Document Control
Document Number: OQ-HPH-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Operational Qualification Protocol for High Pressure Homogenizer in NDDS
Objective: To validate the operational performance of the High Pressure Homogenizer used for size reduction and uniformity in NDDS production.
Scope: This protocol applies to the High Pressure Homogenizer utilized in the R&D and Production areas for the preparation of Liposomes and Lipid Nanoparticles.
Responsibilities:
- Validation Team: Overall execution and documentation of the OQ protocol.
- Quality Assurance: Review and approval of the OQ results.
- Equipment Operator: Conducting the tests as per the protocol.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Training of personnel on equipment operation.
- Availability of necessary materials for testing.
Equipment Description:
The High Pressure Homogenizer is designed for size reduction and uniformity of Liposomes and Lipid Nanoparticles through high-pressure processing, ensuring critical parameters are met for product impact.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Pressure Passes Test | Pressure within specified range as per URS Annex11 Annex15 | Pressure log data |
| OQ-002 | Temperature Check | Temperature remains within defined limits | Temperature log data |
| OQ-003 | Flow Rate Audit | Flow rate within acceptable limits | Flow rate measurements |
Detailed Test Cases:
Test Case OQ-001: Pressure Passes Test
Objective: To confirm that the homogenizer operates within the specified pressure range.
Procedure: Operate the homogenizer and record the pressure readings during operation.
Acceptance Criteria: Pressure must fall within the limits defined in URS Annex11 Annex15.
Evidence: Pressure log data will be reviewed for compliance.
Test Case OQ-002: Temperature Check
Objective: To ensure that the temperature during operation remains within acceptable limits.
Procedure: Monitor the temperature of the homogenizer during operation.
Acceptance Criteria: Temperature must remain within the defined limits.
Evidence: Temperature log data will be reviewed for compliance.
Test Case OQ-003: Flow Rate Audit
Objective: To verify that the flow rate of the product is within acceptable limits.
Procedure: Measure the flow rate during operation and record the data.
Acceptance Criteria: Flow rate must be within acceptable limits.
Evidence: Flow rate measurements will be reviewed for compliance.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be implemented if critical parameters are not met.
Approvals:
Protocol approved by:
___________________________ (Validation Team Lead)
___________________________ (Quality Assurance)