Operational Qualification Protocol for Oscillating Granulator
Document Number: OQ-OSD-OG-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Oscillating Granulator operates according to the specified requirements and meets the acceptance criteria defined in the User Requirements Specification (URS).
Scope
This protocol applies to the Operational Qualification of the Oscillating Granulator used in the production area for the size reduction of wet and dry masses in Solid Dosage Form (OSD) manufacturing.
Responsibilities
The Validation Team is responsible for executing the OQ protocol, documenting results, and reporting any deviations. The Quality Assurance (QA) team will review and approve the protocol and the results.
Prerequisites
- Installation Qualification (IQ) must be completed and approved.
- All necessary documentation and training for personnel must be in place.
Equipment Description
The Oscillating Granulator is designed for size reduction of wet and dry masses. It features adjustable speed settings, interchangeable screen sizes, and a capability to produce a defined particle size distribution (PSD).
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-01 | Verify speed settings at low, medium, and high. | Speed settings must be within ±10% of specified values. | Calibration records, speed test results. |
| OQ-02 | Check screen size for compliance with specifications. | Screen size must match the specified dimensions. | Screen measurement records. |
| OQ-03 | Evaluate output particle size distribution (PSD). | PSD must meet the specifications stated in the URS. | PSD analysis reports. |
Detailed Test Cases
Test Case OQ-01: Speed Verification
Procedure: Set the granulator to low, medium, and high speeds. Measure the actual speed using a tachometer.
Acceptance Criteria: Speed settings must be within ±10% of specified values.
Evidence: Documented speed measurements with timestamps.
Test Case OQ-02: Screen Size Compliance
Procedure: Measure the screen dimensions using calipers to ensure compliance with specifications.
Acceptance Criteria: Screen size must match the specified dimensions.
Evidence: Measurement records and photographs of the screen.
Test Case OQ-03: Particle Size Distribution Analysis
Procedure: Collect samples from the output of the granulator and analyze using a sieve analysis method.
Acceptance Criteria: PSD must meet the specifications stated in the URS.
Evidence: PSD analysis reports and graphs.
Deviations
Any deviations from the acceptance criteria must be documented, investigated, and reported to the QA team for review and resolution.
Approvals
Prepared by: [Insert Name]
Approved by: [Insert Name]
Date of Approval: [Insert Date]