Document Number: DQ-OSD-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for Binder Solution Preparation Tank
Objective: To establish the design qualification of the Binder Solution Preparation Tank to ensure it meets the necessary requirements for binder preparation in the production of solid dosage forms.
Scope: This protocol applies to the Binder Solution Preparation Tank used in the Production/Granulation area for direct product impact.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol.
- Production Team: Responsible for operating the equipment as per the established procedures.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) must be completed prior to DQ execution.
Equipment Description:
The Binder Solution Preparation Tank is designed for the preparation of binder solutions in the granulation process for solid dosage forms. The tank features adjustable agitation speed, temperature control, and a programmable hold time to ensure optimal mixing and preparation of binder solutions.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-1 | Verify agitation speed settings | Agitation speed must be within specified range as per URS | Calibration records |
| DQ-2 | Check temperature control | Temperature must be maintained within specified limits as per URS | Temperature logs |
| DQ-3 | Validate hold time | Hold time must be as specified in URS | Batch records |
Detailed Test Cases:
Test Case DQ-1: Verify Agitation Speed Settings
Procedure: Set the agitation speed to the specified levels and measure using a calibrated speedometer. Document the readings.
Acceptance Criteria: Agitation speed must be within the specified range as per URS.
Evidence: Calibration records and test results must be documented.
Test Case DQ-2: Check Temperature Control
Procedure: Set the temperature to the desired level and monitor for stability over a specified period.
Acceptance Criteria: Temperature must be maintained within specified limits as per URS.
Evidence: Temperature logs and monitoring results must be documented.
Test Case DQ-3: Validate Hold Time
Procedure: Prepare binder solution and maintain for the specified hold time. Document the duration and conditions.
Acceptance Criteria: Hold time must be as specified in URS.
Evidence: Batch records and time logs must be documented.
Deviations:
Any deviations from the acceptance criteria must be documented, including the reason for deviation and the corrective actions taken.
Approvals:
Validation Team Lead: ______________________ Date: ___________
Quality Assurance Representative: ___________ Date: ___________
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