Performance Qualification Protocol for Rotary Sifter Equipment
Document Number: PQ-RS-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Objective
This protocol outlines the performance qualification (PQ) for the Rotary Sifter used in the production of solid dosage forms, ensuring that it meets the specified acceptance criteria as per the User Requirement Specification (URS).
Scope
This protocol applies to the Rotary Sifter located in the Production/Sieving area and is intended for use in the sifting of powders directly impacting product quality.
Responsibilities
The Validation Team is responsible for executing this protocol, while the Quality Assurance department will review and approve the results.
Prerequisites
All relevant personnel must be trained in the operation of the Rotary Sifter and the validation process. All necessary equipment must be calibrated and maintained prior to testing.
Equipment Description
The Rotary Sifter is designed for the efficient sifting of powders. It operates by rotating a screen to separate particles based on size, ensuring uniformity and quality of the final product.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-RS-01 | Verify speed settings during operation. | Speed within specified limits as per URS. | Calibration records and operational logs. |
| PQ-RS-02 | Check screen integrity for wear and tear. | No visible damage; screen meets integrity standards. | Inspection report and photographic evidence. |
Detailed Test Cases
Test Case 1: Speed Verification
Measure the speed of the Rotary Sifter at various settings. Document the readings and compare them against the URS specifications.
Test Case 2: Screen Integrity Check
Inspect the screen for any signs of damage or wear. Ensure that the screen can maintain structural integrity during operation.
Deviations
Any deviations from the protocol must be documented and justified. Approval from the Quality Assurance department is required for any changes to the test plan.
Approvals
Prepared by: ______________________ (Validation Team Lead)
Reviewed by: ______________________ (Quality Assurance)
Approved by: ______________________ (Department Head)