Operational Qualification Protocol for Rotary Sifter in Solid Dosage Form
Document Number: OQ-RS-001
Version: 1.0
Effective Date: [Insert Date]
Approved By: [Insert Approver Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Rotary Sifter operates according to its intended use and meets the acceptance criteria defined in the User Requirement Specification (URS).
Scope
This protocol applies to the Operational Qualification of the Rotary Sifter used in the production and sieving of solid dosage forms (OSD). The qualification will ensure that the equipment performs its intended functions reliably and consistently.
Responsibilities
The following personnel are responsible for the execution of this protocol:
- Validation Team: Execute the OQ protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Staff: Provide operational support during testing.
Prerequisites
- Installation Qualification (IQ) must be completed and approved.
- Operator training on the use of the Rotary Sifter must be completed.
- All necessary materials and equipment must be available and in good condition.
Equipment Description
The Rotary Sifter is a mechanical device used for sifting powders to ensure uniformity and particle size distribution. It operates by rotating a screen that separates particles based on size.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-RS-001 | Verify sifter speed at various settings. | Speed must be within specified range as per URS. | Calibration records, test logs. |
| OQ-RS-002 | Check screen integrity for wear and tear. | No visible damage or holes in the screen. | Visual inspection report. |
Detailed Test Cases
Test Case 1: Verify Sifter Speed
Objective: Ensure the Rotary Sifter operates at the correct speed.
Procedure: Measure the speed of the Rotary Sifter using a tachometer at low, medium, and high settings.
Acceptance Criteria: Speed must be within the range specified in the URS.
Expected Results: Speed readings match URS specifications.
Test Case 2: Check Screen Integrity
Objective: Confirm that the screen is free from damage.
Procedure: Conduct a visual inspection of the screen for any signs of wear or damage.
Acceptance Criteria: No visible damage or holes in the screen.
Expected Results: Screen integrity is intact.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on the qualification results. A deviation report should be generated for any test that does not meet the specified acceptance criteria.
Approvals
This protocol must be reviewed and approved by the Quality Assurance team prior to execution. All results will be reviewed and approved by the same team to ensure compliance with regulatory requirements.