Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Operational Qualification Protocol for Planetary Mixer (Wet Mass)
Objective: To establish the operational qualification of the Planetary Mixer used for wet massing in the production of solid dosage forms.
Scope: This protocol applies to the operational qualification of the Planetary Mixer located in the Production/Granulation area, focusing on its use for wet massing processes.
Responsibilities:
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Production Personnel: Responsible for operating the equipment as per the established procedures.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- Operators must be trained on the equipment operation.
Equipment Description:
The Planetary Mixer is designed for wet massing applications in the production of solid dosage forms. The mixer features adjustable speed settings, a bowl clearance mechanism, and is constructed from stainless steel to ensure compliance with cGMP standards.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-01 | Verify mixer speed settings at low, medium, and high. | Speed settings must match specifications in the URS. | Calibration records and speed test results. |
| OQ-001-02 | Measure mixing time for a standard batch. | Mixing time must be within URS specifications. | Time logs and batch records. |
| OQ-001-03 | Check bowl clearance mechanism for proper operation. | Bowl clearance must allow for effective mixing without obstruction. | Inspection report and operational logs. |
Detailed Test Cases:
- Test ID: OQ-001-01
Procedure: Set the mixer to low, medium, and high speeds sequentially. Measure the actual speed using a calibrated tachometer.
Acceptance Criteria: Speed settings must match specifications in the URS.
Evidence: Documented calibration records and speed test results.
- Test ID: OQ-001-02
Procedure: Conduct a wet massing operation for a standard batch and record the total mixing time.
Acceptance Criteria: Mixing time must be within URS specifications.
Evidence: Time logs and batch records to be maintained.
- Test ID: OQ-001-03
Procedure: Inspect the bowl clearance mechanism before and after operation for any obstructions or failures.
Acceptance Criteria: Bowl clearance must allow for effective mixing without obstruction.
Evidence: Inspection report and operational logs.
Deviations: Any deviations from the acceptance criteria must be documented and reviewed. Investigate the root cause and implement corrective actions as necessary.
Approvals:
- Validation Team Lead: ___________________ Date: ___________
- Quality Assurance Manager: ________________ Date: ___________