Document Control Number: PQ-OSD-EXT-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Performance Qualification Protocol for Twin Screw Extruder in Solid Dosage Form Production
Meta Description: This document outlines the Performance Qualification (PQ) protocol for the Twin Screw Extruder used in the production of solid dosage forms, focusing on critical parameters and acceptance criteria.
Tags: Equipment Validation, Performance Qualification, Twin Screw Extruder, Solid Dosage Form, Pharmaceutical Compliance
Objective
The objective of this Performance Qualification (PQ) protocol is to ensure that the Twin Screw Extruder operates consistently within defined parameters to produce quality pellets and solid dispersions.
Scope
This protocol applies to the Performance Qualification of the Twin Screw Extruder utilized in the production of solid dosage forms in the Production/Pellets area.
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 operating the equipment and providing necessary data during the PQ process.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary materials and resources.
- Training of personnel on equipment operation and safety protocols.
Equipment Description
The Twin Screw Extruder is designed for the extrusion of pellets and solid dispersions. It features adjustable screw speed, temperature zones, and torque control to optimize the extrusion process.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-EXT-001 | Measure screw speed during operation. | Within specified range as per URS Annex11. | Calibration report and operational log. |
| PQ-EXT-002 | Monitor temperature zones. | Temperature within specified limits as per URS Annex11. | Temperature log and calibration report. |
| PQ-EXT-003 | Record torque during operation. | Torque within specified limits as per URS Annex11. | Torque log and operational report. |
Detailed Test Cases
Test Case 1: Validate screw speed.
- Set the screw speed to the target value.
- Document the actual speed reading.
- Compare the reading to the acceptance criteria.
Test Case 2: Validate temperature zones.
- Set the temperature for each zone.
- Monitor and document the temperature readings.
- Ensure all readings are within the acceptance criteria.
Test Case 3: Validate torque.
- Run the extruder at specified conditions.
- Record torque values.
- Ensure all values meet acceptance criteria.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. The validation team will assess the impact on product quality and determine appropriate corrective actions.
Approvals
This protocol must be approved by the Quality Assurance department before execution.