Document Control
Document ID: PQ-RB-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Performance Qualification Protocol for Ribbon Blender
Objective: To establish and verify the performance of the Ribbon Blender in blending powders for solid dosage forms, ensuring compliance with defined acceptance criteria.
Scope: This protocol applies to the Ribbon Blender used in the production area for blending solid dosage forms. It encompasses the qualification of the equipment to ensure it meets the required specifications and performance standards.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Team: Responsible for providing access to the equipment and necessary resources.
Prerequisites:
- Completion of Installation Qualification (IQ) for the Ribbon Blender.
- Operational Qualification (OQ) completed and approved.
- Personnel trained on the operation of the Ribbon Blender.
Equipment Description:
The Ribbon Blender is designed to blend powders uniformly. It operates at adjustable RPM settings and has a mixing chamber capable of handling various batch sizes. The critical parameters for this equipment include RPM and mixing time.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-RB-001-01 | Set the Ribbon Blender to specified RPM and blend for the defined mixing time. | Blending is uniform with no segregation of powders. | Visual inspection and sampling. |
| PQ-RB-001-02 | Record RPM and mixing time during blending. | RPM within ± 5% of target; mixing time as per URS. | Data logs and time stamps. |
Detailed Test Cases:
Test Case 1: Validate blending uniformity at 50 RPM for 10 minutes.
- Procedure: Operate the Ribbon Blender at 50 RPM and blend for 10 minutes.
- Acceptance Criteria: No visible segregation; sample testing shows consistent composition.
- Evidence: Visual inspection and lab analysis results.
Test Case 2: Validate blending time effectiveness at 75 RPM.
- Procedure: Operate the Ribbon Blender at 75 RPM for 15 minutes.
- Acceptance Criteria: Blending completed within specified time with uniform distribution.
- Evidence: Monitoring logs and analytical results.
Deviations:
Any deviations from the protocol must be documented, including the reason for deviation and the impact assessment on the blending process.
Approvals:
Protocol approved by:
- _________________________ (Validation Team Lead)
- _________________________ (Quality Assurance)
- _________________________ (Production Manager)