Document Control:
Version: 1.0
Date: [Insert Date]
Prepared by: [Insert Name]
Reviewed by: [Insert Name]
Approved by: [Insert Name]
Performance Qualification Protocol for Binder Solution Preparation Tank
Objective: To validate the performance of the Binder Solution Preparation Tank to ensure it meets the specified requirements for binder preparation in the Solid Dosage Form production process.
Scope: This protocol applies to the Binder Solution Preparation Tank used in the Production/Granulation area for the preparation of binder solutions impacting product quality directly.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Personnel: Responsible for operating the equipment during testing.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Completion of Operational Qualification (OQ).
- Availability of all necessary materials and equipment.
Equipment Description:
The Binder Solution Preparation Tank is designed for the preparation of binder solutions used in the granulation process of solid dosage forms. It features adjustable agitation speed, temperature control, and a holding time mechanism.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Verify agitation speed settings. | Agitation speed must be within specified range as per URS. | Calibration records and observation logs. |
| PQ-002 | Measure and record temperature during operation. | Temperature must remain within specified limits as per URS. | Temperature logs and monitoring data. |
| PQ-003 | Measure and record holding time of binder solution. | Holding time must meet the requirements as per URS. | Time logs and observation records. |
Detailed Test Cases:
- Test Case 1: Set the agitation speed to the specified level and verify with a calibrated device. Document the speed.
- Test Case 2: Set the desired temperature on the control panel, monitor the actual temperature, and document deviations.
- Test Case 3: Initiate the binder solution preparation and record the time taken. Ensure it complies with the URS.
Deviations:
Any deviations observed during the testing phase must be documented in a deviation log, including the nature of the deviation, potential impact on product quality, and corrective actions taken.
Approvals:
All results must be reviewed and approved by the Quality Assurance team before the final validation report is issued.