Document Number: OQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approved By: [Name]
Operational Qualification Protocol for Spheronizer/Marumerizer
Objective: To validate the operational performance of the Spheronizer/Marumerizer used in the production of solid dosage forms, ensuring compliance with defined acceptance criteria.
Scope: This protocol applies to the Spheronizer/Marumerizer located in the Production area specifically for the spheronization process of pellets. It encompasses all operational parameters and their impact on product quality.
Responsibilities:
- Validation Team: Execute the protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide operational support and access to equipment.
Prerequisites:
- Equipment installation qualification (IQ) completed.
- Training of personnel on equipment operation.
- Availability of necessary tools and materials for testing.
Equipment Description: The Spheronizer/Marumerizer is designed for the spheronization of pellets, ensuring the desired particle size distribution (PSD) and shape through controlled mechanical processes.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-01 | Verify plate speed settings. | Plate speed within specified range. | Calibration records. |
| OQ-001-02 | Measure spheronization time. | Time matches established protocol. | Time logs. |
| OQ-001-03 | Assess particle size distribution (PSD). | PSD meets URS criteria. | PSD analysis report. |
| OQ-001-04 | Evaluate pellet shape. | Shape conforms to specifications. | Visual inspection records. |
Detailed Test Cases:
- Test Case OQ-001-01:
Procedure: Adjust the plate speed to the prescribed settings. Record the speed using calibrated equipment.
Acceptance Criteria: Plate speed must be within the defined range as per the URS.
- Test Case OQ-001-02:
Procedure: Run the spheronization process and log the time taken for completion.
Acceptance Criteria: Time must match the established protocol duration.
- Test Case OQ-001-03:
Procedure: Collect samples post-spheronization and analyze for PSD using appropriate methods.
Acceptance Criteria: PSD must meet the specifications outlined in the URS.
- Test Case OQ-001-04:
Procedure: Conduct a visual inspection of the pellets to assess shape conformity.
Acceptance Criteria: Pellets must conform to defined shape specifications.
Deviations: Any deviations from the established procedures or acceptance criteria must be documented and evaluated for impact on product quality. A corrective action plan should be developed as necessary.
Approvals:
_________________________ Validation Team Lead
_________________________ Quality Assurance