Operational Qualification Protocol for MDI Bulk Compounding Vessel
Document Control:
Document Number: OQ-MDI-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Objective:
The purpose of this Operational Qualification (OQ) protocol is to verify that the MDI Bulk Compounding Vessel (Jacketed SS) operates within specified limits to ensure the quality of the suspension/solution prepared for Metered Dose Inhalers (MDI).
Scope:
This protocol applies to the Operational Qualification of the MDI Bulk Compounding Vessel utilized in the production of inhalation formulations. It encompasses all critical parameters that impact product quality.
Responsibilities:
- Validation Team: Preparation and execution of the OQ protocol.
- Quality Assurance: Review and approval of the OQ protocol and results.
- Production Team: Participation in the execution of the OQ protocol.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- All personnel involved must be trained on the equipment and procedures.
Equipment Description:
The MDI Bulk Compounding Vessel is a jacketed stainless steel container designed for the preparation of solutions and suspensions for Metered Dose Inhalers. It is equipped with temperature control and mixing capabilities to ensure homogeneity and stability of the product.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify temperature control functionality. | Temperature maintained within 2°C of set point. | Temperature log data. |
| OQ-02 | Check mixing speed and consistency. | Mixing speed within specified range; visual homogeneity. | Mixing speed log; visual inspection report. |
| OQ-03 | Perform leakage test. | No leaks detected during test. | Leak test report. |
Detailed Test Cases:
- Test Case OQ-01:
- Procedure: Set temperature to 25°C and monitor for 30 minutes.
- Acceptance Criteria: Temperature should remain within 23°C to 27°C.
- Data Integrity Check: Ensure temperature data logging system is functioning and data is retrievable.
- Test Case OQ-02:
- Procedure: Set mixing speed to 100 RPM and observe for 15 minutes.
- Acceptance Criteria: Visual inspection confirms homogeneity.
- Data Integrity Check: Verify mixing speed recorded in the system matches manual readings.
- Test Case OQ-03:
- Procedure: Conduct a pressure test for 10 minutes.
- Acceptance Criteria: No leaks should be detected.
- Data Integrity Check: Document all pressure readings and confirm against baseline.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed to determine the impact on product quality.
Approvals:
__________________________ Validation Team Lead
__________________________ Quality Assurance
__________________________ Production Manager