Document Control:
- Document ID: PQ-OSD-OB-001
- Version: 1.0
- Effective Date: [Insert Date]
- Reviewed By: [Insert Name]
- Approval Date: [Insert Date]
Performance Qualification Protocol for Octagonal Blender
Objective: To validate the performance of the Octagonal Blender to ensure it meets the specified acceptance criteria for blending powders and granules in solid dosage form production.
Scope: This protocol applies to the performance qualification of the Octagonal Blender used in the production area for blending processes impacting 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 during the qualification process.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- Operational Qualification (OQ) must be completed and approved.
- All personnel involved must be trained on the equipment and procedures.
Equipment Description: The Octagonal Blender is designed for blending powders and granules. It operates at variable RPM and is equipped with safety features to ensure operational integrity.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-OB-01 | Set the blender to specified RPM and blend for designated time. | Blending time must not exceed specified limits. | Blending log and RPM readings. |
| PQ-OB-02 | Verify uniformity of blended product. | Uniformity within specified limits as per URS. | Sample analysis report. |
Detailed Test Cases:
Test Case 1: RPM Blending Time
- Set the Octagonal Blender to the specified RPM.
- Initiate blending for the defined time.
- Record the RPM and blending time.
- Compare results with acceptance criteria.
Test Case 2: Product Uniformity
- Collect samples from the blended product.
- Conduct analysis for uniformity.
- Document results and compare against acceptance criteria.
Deviations:
Any deviations from the protocol must be documented, including the reason for deviation and the impact on the qualification results. A corrective action plan must be established and approved.
Approvals:
Signature of Validation Team Lead: ____________________
Signature of Quality Assurance: ____________________
Signature of Production Supervisor: ____________________