Document Control Number: PQ-OSD-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Reviewer Name]
Approval Date: [Insert Approval Date]
Performance Qualification Protocol for Centrifugal Sifter in Solid Dosage Form Production
Objective: To validate the performance of the Centrifugal Sifter to ensure it meets the specified requirements for high-throughput sifting in the production of solid dosage forms.
Scope: This protocol applies to the Performance Qualification of the Centrifugal Sifter located in the Production/Sieving area, impacting product quality directly.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ documentation.
- Production Staff: Responsible for operating the equipment as per the validated procedures.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the operation of the Centrifugal Sifter.
- Availability of all necessary materials and equipment for testing.
Equipment Description: The Centrifugal Sifter is designed for high-throughput sifting of solid dosage forms, ensuring effective separation of particles based on size. The critical parameters include rotor speed and screen integrity.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Measure rotor speed at maximum setting. | Rotor speed should be within the specified range per URS. | Calibration log and speed measurement data. |
| PQ-02 | Inspect screen integrity for wear and tear. | No visible damage or excessive wear on the screen. | Inspection report and photographs. |
Detailed Test Cases:
- Test Case PQ-01:
- Procedure: Set the Centrifugal Sifter to maximum rotor speed and record the actual speed.
- Acceptance Criteria: The rotor speed must match the specifications outlined in the URS.
- Evidence: Documented speed readings and calibration records.
- Test Case PQ-02:
- Procedure: Visually inspect the sifting screen for any signs of damage or wear.
- Acceptance Criteria: Screen must be free from any visible damage.
- Evidence: Inspection report with photographs attached.
Deviations: Any deviations from the acceptance criteria must be documented, investigated, and resolved prior to final approval of the PQ protocol.
Approvals:
- ____________________ (Validation Team Lead)
- ____________________ (Quality Assurance)