Performance Qualification Protocol for Vibro Sifter in Solid Dosage Form
Document Number: PQ-VS-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Vibro Sifter operates consistently and effectively within specified parameters to ensure the quality of solid dosage forms.
Scope
This protocol applies to the Vibro Sifter utilized in the production area for sifting and de-lumping powders and granules, impacting product quality directly.
Responsibilities
The Validation Team is responsible for executing the PQ protocol, while the Quality Assurance (QA) team will review and approve the results.
Prerequisites
- Installation Qualification (IQ) and Operational Qualification (OQ) must be completed.
- All personnel involved must be trained on the equipment and procedures.
- Documentation of the User Requirement Specification (URS) must be available.
Equipment Description
The Vibro Sifter is designed for sifting and de-lumping powders and granules in the production of solid dosage forms. It operates by utilizing vibration to separate materials based on size and density.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-VS-01 | Verify screen integrity | No visible tears or holes | Inspection report |
| PQ-VS-02 | Measure RPM during operation | Within specified range | RPM log |
| PQ-VS-03 | Monitor vibration levels | Within specified limits | Vibration analysis report |
Detailed Test Cases
Test Case 1: Verify Screen Integrity
Procedure: Inspect the screen for any visible damage.
Acceptance Criteria: No visible tears or holes in the screen.
Evidence: Documented inspection report confirming screen condition.
Test Case 2: Measure RPM During Operation
Procedure: Operate the Vibro Sifter and record RPM readings.
Acceptance Criteria: RPM must be within the specified operational range as defined in the URS.
Evidence: RPM log sheet with recorded values.
Test Case 3: Monitor Vibration Levels
Procedure: Use a vibration meter to measure vibration levels during operation.
Acceptance Criteria: Vibration levels must be within the specified limits outlined in the URS.
Evidence: Vibration analysis report documenting measurements.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be implemented to address any issues found during testing.
Approvals
Prepared by: [Name]
Approved by: [Name]
Date of Approval: [Date]