Document ID: PQ-VD-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Reviewer Name]
Approval Date: [Approval Date]
Performance Qualification Protocol for Vacuum Tray Dryer
This document outlines the Performance Qualification (PQ) protocol for the Vacuum Tray Dryer used in the production of Solid Dosage Forms.
Objective: To ensure that the Vacuum Tray Dryer operates consistently and meets the established acceptance criteria for low-temperature drying processes.
Scope: This protocol applies to the Vacuum Tray Dryer located in the Production/Drying area, impacting the quality of solid dosage forms directly.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Team: Responsible for providing access to the equipment and assisting in the execution of the protocol.
Prerequisites:
- Installation Qualification (IQ) and Operational Qualification (OQ) must be completed and approved.
- All relevant personnel must be trained on the operation of the Vacuum Tray Dryer.
Equipment Description: The Vacuum Tray Dryer is designed for low-temperature drying of solid dosage forms, providing a controlled vacuum environment to ensure uniform temperature distribution and moisture removal.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-01 | Verify vacuum level at specified settings. | Vacuum level must be within ±5% of target. | Calibration report and log. |
| PQ-02 | Measure temperature uniformity across trays. | Temperature variation must not exceed ±2°C. | Temperature mapping report. |
Detailed Test Cases:
- Test Case PQ-01: Measure the vacuum level using calibrated gauge. Record readings at three different points.
- Test Case PQ-02: Conduct temperature mapping using thermocouples placed on each tray. Analyze data for uniformity.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. Corrective actions should be implemented as necessary.
Approvals:
- Validation Team Lead: ____________________ Date: ___________
- Quality Assurance Manager: ____________________ Date: ___________