Document ID: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Design Qualification Protocol for Liquid Manufacturing Vessel
Objective: This protocol outlines the design qualification for the Liquid Manufacturing Vessel (SS Jacketed Tank) used in the production of non-sterile liquids, ensuring compliance with regulatory requirements and operational efficiency.
Scope: This protocol applies to the validation of the Liquid Manufacturing Vessel utilized in the compounding of syrups, liquids, and suspensions in the production/manufacturing area.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Review and approve the DQ protocol and final report.
- Production Team: Provide operational insights and support during testing.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) of the Liquid Manufacturing Vessel.
- Availability of all necessary equipment and materials for testing.
Equipment Description: The Liquid Manufacturing Vessel is a stainless steel jacketed tank designed for the compounding of non-sterile liquids. It features controlled agitation, temperature regulation, and a PLC for monitoring and logging critical parameters.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify Agitation Speed | Agitation speed within specified range | PLC log report |
| T2 | Verify Temperature Control | Temperature maintained within limits | Temperature log report |
| T3 | Verify Hold Time | Hold time meets specifications | Batch record |
Detailed Test Cases:
- Test Case T1: Measure the agitation speed using the PLC interface. Document the results in the log report. Acceptance criteria: Speed must be within the defined operational range.
- Test Case T2: Monitor the temperature during operation. Ensure the temperature remains within specified limits for the entire duration. Document findings in the temperature log report.
- Test Case T3: Confirm the hold time by reviewing batch records. Ensure compliance with the specified hold time for each batch.
Data Integrity Checks:
- Regular review of PLC logs to ensure no unauthorized changes.
- Backup of all data logs at the end of each production run.
- Audit trails enabled for all critical parameter logging.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A deviation report should be generated to outline the issue and corrective actions taken.
Approvals:
- Validation Team Lead: ______________________ Date: __________
- Quality Assurance Manager: ______________________ Date: __________
- Production Manager: ______________________ Date: __________