Document ID: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Prepared By: Validation Team
Approved By: QA Department
Design Qualification Protocol for Solution Preparation Tank in Nasal & Otic Product Production
Objective: To establish the design qualification requirements for the Solution Preparation Tank used in the production of nasal and otic products, ensuring compliance with regulatory standards and product specifications.
Scope: This protocol covers the qualification of the Solution Preparation Tank utilized in the production area for the preparation of sterile and non-sterile formulations.
Responsibilities:
- Validation Team: Responsible for executing the qualification protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the qualification documentation.
- Production Team: Responsible for operating the equipment as per the defined procedures.
Prerequisites:
- Completion of the User Requirements Specification (URS) for the Solution Preparation Tank.
- Installation Qualification (IQ) must be completed prior to executing this protocol.
Equipment Description: The Solution Preparation Tank is designed for dissolving ingredients and preparing formulations for nasal and otic products. It features controlled temperature, mixing speed, and conductivity monitoring, with data logged via a PLC system.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001-01 | Verify temperature settings during operation. | Temperature must remain within specified range as per URS Annex 11. | Temperature logs and operator records. |
| DQ-001-02 | Test mixing speed during formulation preparation. | Mixing speed must meet the defined specifications. | Mixing speed logs and calibration records. |
| DQ-001-03 | Check conductivity of prepared solution. | Conductivity must be within acceptable limits as per formulation requirements. | Conductivity test results and calibration certificates. |
| DQ-001-04 | Review PLC logs for data integrity. | All logs must be complete and accurate with no discrepancies. | PLC log reports and audit trail review. |
Detailed Test Cases:
- Test Case 1: Verify that the temperature control system operates correctly by setting the tank to the required temperature and monitoring for stability over a specified duration.
- Test Case 2: Confirm that the mixing speed is adjustable and can maintain the specified speed during formulation preparation without deviation.
- Test Case 3: Conduct conductivity tests on the prepared solution to ensure it meets the required specifications.
- Test Case 4: Perform a review of PLC logs to ensure all data is recorded accurately and is retrievable without loss.
Deviations: Any deviations from the acceptance criteria must be documented, with a detailed investigation and corrective actions proposed.
Approvals:
- Validation Team Lead: ___________________ Date: ___________
- Quality Assurance Manager: ______________ Date: ___________