Document Control
Document Number: PQ-OSD-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed by: [Name]
Approval Date: [Date]
Performance Qualification Protocol for Inline Sifter in Solid Dosage Form
Objective: The objective of this Performance Qualification (PQ) protocol is to verify that the Inline Sifter operates within specified parameters to ensure product quality during the sifting process in solid dosage form production.
Scope: This protocol applies to the Inline Sifter used in the production area for sifting during the transfer of solid dosage forms. It covers the assessment of critical parameters affecting product quality.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ documentation.
- Production Team: Responsible for providing access to the equipment and supporting the validation activities.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary materials and equipment for testing.
- Training of personnel involved in the PQ process.
Equipment Description:
The Inline Sifter is designed for sifting solid dosage forms during transfer. It operates by utilizing a flow rate screen differential pressure (DP) to ensure uniformity and quality of the product. The sifter is critical for maintaining the integrity of the product during processing.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Measure flow rate during operation. | Flow rate within specified limits as per URS. | Flow rate measurement log. |
| PQ-02 | Measure differential pressure across the screen. | DP within acceptable range as per URS. | DP measurement log. |
Detailed Test Cases:
- Test Case PQ-01: Validate the flow rate of the Inline Sifter. Record the flow rate at various operational settings and ensure it meets the URS specifications.
- Test Case PQ-02: Validate the differential pressure across the sifter screen. Document the readings and verify they align with the acceptance criteria outlined in the URS.
Deviations:
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A deviation report should be generated and reviewed by the Quality Assurance team.
Approvals:
All results and documentation must be reviewed and approved by the Quality Assurance team prior to the finalization of this PQ protocol.