Performance Qualification Protocol for Single Screw Extruder in Solid Dosage Form Production
Document Number: PQ-EXT-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Single Screw Extruder used in the production of solid dosage form pellets to ensure it operates within specified limits and meets the defined acceptance criteria.
Scope
This protocol applies to the Single Screw Extruder located in the Production area for the manufacturing of pellets. It covers the validation of equipment performance, including the critical parameters that impact product quality.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and ensuring compliance with regulatory standards. The Quality Assurance (QA) team will review and approve the final report.
Prerequisites
All operators must be trained on the use of the Single Screw Extruder. The equipment must be installed and operational before commencing the PQ. Relevant documentation, including User Requirement Specifications (URS) and Installation Qualification (IQ) reports, must be available for reference.
Equipment Description
The Single Screw Extruder is designed for the extrusion of pellets. It features adjustable screw speed, feed rate, and torque settings, which are critical for the production process.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| TP-01 | Measure screw speed at various settings. | Within specified range as per URS Annex11. | Calibration logs and measurement data. |
| TP-02 | Monitor feed rate during operation. | Consistent with URS Annex11. | Feed rate logs and batch records. |
| TP-03 | Record torque readings at different speeds. | Must not exceed specified limits. | Torque measurement data. |
Detailed Test Cases
1. **Screw Speed Test:** Adjust the screw speed to the low, medium, and high settings. Record the speed and ensure it meets the URS Annex11 specifications.
2. **Feed Rate Test:** Set the feed rate to the specified values and monitor for consistency over a production run. Document any deviations.
3. **Torque Test:** Operate the extruder at various speeds and record the torque. Ensure that the readings remain within acceptable limits.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed to address the root cause and prevent recurrence.
Approvals
This protocol must be approved by the Quality Assurance team before execution. All results and deviations must be reviewed and signed off by the validation team and QA.
Data Integrity Checks
During this stage, ensure that all data collected is securely stored and backed up. Implement checks to verify data accuracy and completeness, including regular audits of the measurement logs and calibration records.