Design Qualification Protocol for Vibro Sifter in Solid Dosage Form
Document ID: DQ-OSD-VS-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approved By: [Name]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Vibro Sifter is designed and implemented to meet the specified requirements for the sifting and de-lumping of powders and granules in the production area.
Scope
This protocol applies to the Vibro Sifter used in the production of solid dosage forms (OSD) and outlines the validation requirements for its operational performance.
Responsibilities
- Validation Team: Responsible for executing the validation protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Production Team: Responsible for operating the equipment in accordance with the validated procedures.
Prerequisites
- Completion of User Requirement Specification (URS).
- Installation of the Vibro Sifter in the designated production area.
- Training of personnel on equipment operation and safety procedures.
Equipment Description
The Vibro Sifter is designed for the efficient sifting and de-lumping of powders and granules. It operates using a vibrational motion to separate particles based on size and integrity.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify screen integrity. | No visible tears or damage. | Inspection report. |
| DQ-02 | Measure RPM during operation. | RPM within specified limits. | Calibration records. |
| DQ-03 | Monitor vibration levels. | Vibration within acceptable range. | Vibration test report. |
Detailed Test Cases
Test Case DQ-01: Screen Integrity
Procedure: Inspect the screen for any visible tears or damage before and after operation.
Acceptance Criteria: No visible tears or damage should be present.
Evidence: Inspection report documenting the condition of the screen.
Test Case DQ-02: RPM Measurement
Procedure: Use a tachometer to measure the RPM of the Vibro Sifter during operation.
Acceptance Criteria: RPM must be within specified limits as per URS.
Evidence: Calibration records showing RPM measurements.
Test Case DQ-03: Vibration Monitoring
Procedure: Utilize a vibration meter to monitor the vibration levels during operation.
Acceptance Criteria: Vibration levels must remain within acceptable ranges.
Evidence: Vibration test report documenting the findings.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan must be developed and implemented as necessary.
Approvals
This protocol must be approved by the Quality Assurance team and signed off by the responsible personnel.