Document Control Number: PQ-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approval Date: YYYY-MM-DD
Performance Qualification Protocol for Auto Coating Pan
This document outlines the Performance Qualification (PQ) protocol for the Auto Coating Pan used in the film coating process of solid dosage forms.
Objective: To validate the performance of the Auto Coating Pan to ensure it meets the defined acceptance criteria for film coating.
Scope: This protocol applies to the Auto Coating Pan (Perforated Pan Coater) used in the production area for coating solid dosage forms.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Team: Responsible for providing support during execution.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- All personnel trained on equipment operation and safety procedures.
- Availability of necessary materials and instruments for testing.
Equipment Description: The Auto Coating Pan is a perforated pan coater designed for film coating solid dosage forms. It operates under controlled conditions to ensure uniform application of the coating material.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Measure inlet and exhaust temperatures during operation. | Inlet temp: 60-80°C; Exhaust temp: 40-60°C | Temperature logs |
| PQ-02 | Verify spray rate during coating. | Spray rate: 1-3 mL/min | Flow rate measurements |
| PQ-03 | Check pan speed during operation. | Pan speed: 10-30 RPM | Speed logs |
| PQ-04 | Verify PLC functionality. | PLC should operate without errors | PLC log files |
Detailed Test Cases:
- PQ-01: Record the inlet and exhaust temperatures at the beginning, middle, and end of the coating process. Ensure compliance with acceptance criteria.
- PQ-02: Measure the spray rate using calibrated flow meters during the coating process. Document any deviations.
- PQ-03: Monitor and record the pan speed using a tachometer. Ensure it remains within the specified range throughout the process.
- PQ-04: Perform a functionality check on the PLC system. Document any errors or malfunctions.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Corrective actions should be implemented as necessary.
Approvals:
- Validation Manager: _______________________ Date: ___________
- Quality Assurance: _______________________ Date: ___________
Data Integrity Checks:
- Ensure all data is recorded in real-time and backed up at the end of each session.
- Conduct periodic audits of data logs for accuracy and completeness.
- Utilize encrypted storage solutions for data retention.