Operational Qualification Protocol for Multi Mill in Solid Dosage Form Production
Document Number: OQ-001
Version: 1.0
Effective Date: YYYY-MM-DD
Prepared By: [Name]
Reviewed By: [Name]
Approved By: [Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Multi Mill operates within specified limits and meets the requirements outlined in the User Requirements Specification (URS). This includes confirming the critical parameters such as rotor speed, screen integrity, and output particle size distribution (PSD).
Scope
This protocol applies to the Multi Mill used in the production area for milling and sizing powders and granules in the Solid Dosage Form (OSD) manufacturing process.
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 Team: Responsible for providing access and support during the OQ execution.
Prerequisites
- Multi Mill has been installed and calibrated according to manufacturer’s specifications.
- All operators have been trained on the use of the Multi Mill.
- Relevant SOPs are in place and accessible.
Equipment Description
The Multi Mill is a versatile milling equipment designed for the size reduction of powders and granules. It operates using a high-speed rotor that facilitates the milling process, ensuring uniform particle size distribution.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-001 | Measure rotor speed at various settings. | Rotor speed must be within ±10% of specified RPM. | Calibration report and speed measurement logs. |
| OQ-002 | Inspect screen integrity for wear and tear. | No visible damage or excessive wear. | Inspection checklist and photographs. |
| OQ-003 | Collect output PSD samples. | Output PSD must meet specifications outlined in the URS. | PSD analysis report. |
Detailed Test Cases
Test Case OQ-001: Rotor Speed Measurement
Procedure: Use a calibrated tachometer to measure the rotor speed at the following settings: low, medium, and high.
Acceptance Criteria: Rotor speed must be within ±10% of specified RPM.
Test Case OQ-002: Screen Integrity Inspection
Procedure: Visually inspect the screen for any signs of damage or excessive wear.
Acceptance Criteria: No visible damage or excessive wear.
Test Case OQ-003: Output PSD Analysis
Procedure: Collect samples of the milled product and analyze for particle size distribution using appropriate analytical methods.
Acceptance Criteria: Output PSD must meet specifications outlined in the URS.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan must be developed and implemented.
Approvals
Prepared By: ___________________ Date: _______________
Reviewed By: ___________________ Date: _______________
Approved By: ___________________ Date: _______________