Document Control:
Document ID: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Design Qualification Protocol for Solution Preparation Tank
Objective: To establish and document the Design Qualification (DQ) for the Solution Preparation Tank used in the preparation of IV infusions.
Scope: This protocol applies to the validation of the Solution Preparation Tank utilized in the production area for dissolving solids into solutions for IV infusions (LVP/SVP – Bags/Bottles).
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Production Personnel: Responsible for operating the equipment during the validation process.
Prerequisites:
- Completion of User Requirement Specification (URS) for the Solution Preparation Tank.
- Installation Qualification (IQ) must be completed prior to DQ execution.
Equipment Description:
The Solution Preparation Tank is designed for the dissolution of salt and sugar into solutions, essential for IV infusion formulations. The equipment features controlled temperature, agitation, and conductivity monitoring capabilities.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify temperature control functionality. | Temperature maintained within specified range as per URS Annex11. | Temperature logs, PLC logs. |
| DQ-02 | Confirm agitation time settings. | Agitation time meets specifications outlined in URS Annex11. | Agitation logs, PLC logs. |
| DQ-03 | Check conductivity monitoring system. | Conductivity readings within acceptable limits as per URS Annex11. | Conductivity logs, PLC logs. |
Detailed Test Cases:
- Test Case DQ-01: Set the temperature to the desired set point and monitor for stability. Record temperature data over a defined period.
- Test Case DQ-02: Initiate agitation and confirm the duration against specifications. Document any discrepancies.
- Test Case DQ-03: Conduct a conductivity test with a known standard solution to verify the accuracy of the monitoring system.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on the validation process. A deviation report must be generated and approved by Quality Assurance.
Approvals:
- Validation Team Lead: ___________________ Date: ___________
- Quality Assurance: ______________________ Date: ___________
Data Integrity Checks:
- Automated data capture from PLC to ensure no manual entry errors.
- Regular audits of data logs to verify consistency and accuracy.