Operational Qualification Protocol for Co-Mill/Conical Mill in Solid Dosage Form Production
Document Control:
Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Objective: To ensure that the Co-Mill/Conical Mill operates according to predetermined specifications and meets the acceptance criteria outlined in the User Requirement Specification (URS).
Scope: This protocol covers the operational qualification of the Co-Mill/Conical Mill used for de-agglomeration and sizing in the production of solid dosage forms.
Responsibilities:
- Validation Team: Overall execution and documentation of the OQ protocol.
- Production Team: Operation of the Co-Mill/Conical Mill during testing.
- Quality Assurance: Review and approval of the OQ protocol and results.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- All personnel involved in the OQ must be trained on the equipment.
Equipment Description: The Co-Mill/Conical Mill is designed for the de-agglomeration and sizing of solid dosage forms. It utilizes an impeller to achieve desired particle size distribution (PSD) through adjustable screen sizes.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify impeller speed settings at specified RPM. | Impeller speed must match the specified settings within ±5%. | Calibration logs and speed measurements. |
| OQ-02 | Check screen size installation and integrity. | Screen size must match the specifications in the URS. | Visual inspection and documentation of screen size. |
| OQ-03 | Measure output PSD after milling. | Output PSD must fall within the defined range in the URS. | PSD analysis report. |
Detailed Test Cases:
Test Case OQ-01: Impeller Speed Verification
Objective: To verify that the impeller speed settings are within the acceptable range.
Procedure: Operate the Co-Mill at designated RPM settings and record the actual speed using a tachometer.
Acceptance Criteria: Impeller speed must match the specified settings within ±5%.
Evidence: Calibration logs and speed measurements will be documented.
Test Case OQ-02: Screen Size Integrity Check
Objective: To ensure the correct screen size is installed and in good condition.
Procedure: Inspect the installed screen for the correct size and any signs of wear or damage.
Acceptance Criteria: Screen size must match the specifications in the URS.
Evidence: Visual inspection results will be documented.
Test Case OQ-03: Output PSD Measurement
Objective: To measure the particle size distribution of the output.
Procedure: Collect samples post-milling and analyze using a suitable particle size analyzer.
Acceptance Criteria: Output PSD must fall within the defined range in the URS.
Evidence: PSD analysis report will be attached.
Deviations: Any deviations from the acceptance criteria will be documented and assessed for impact on product quality.
Approvals:
Prepared By: ____________________ Date: ___________
Approved By: ____________________ Date: ___________