Document Control
Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for Sterile Powder Compounding Vessel
Objective: To establish and document the design qualification of the Sterile Powder Compounding Vessel (Jacketed SS) used in the preparation of sterile bulk solutions prior to lyophilization.
Scope: This protocol applies to the validation of the Sterile Powder Compounding Vessel located in the Production Area, ensuring compliance with regulatory requirements and internal standards.
Responsibilities:
- Validation Team: Execute and document the qualification activities.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide operational input and support during qualification.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) must be completed prior to DQ.
- Availability of relevant Standard Operating Procedures (SOPs).
Equipment Description:
The Sterile Powder Compounding Vessel (Jacketed SS) is designed for the preparation of sterile bulk solutions. It features a jacket for temperature control and is equipped with a PLC for monitoring and control of critical parameters.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-001-01 | Verify agitation speed settings | Agitation speed within specified range | Calibration records |
| DQ-001-02 | Check temperature control functionality | Temperature maintained as per specifications | Temperature logs |
| DQ-001-03 | Validate hold time parameters | Hold time meets defined criteria | Process records |
| DQ-001-04 | Audit PLC for data integrity | Audit trail complete and accurate | PLC audit report |
Detailed Test Cases:
- Test Case 1: Verify that the agitation speed can be set and maintained within the specified range. Record actual speeds during operation.
- Test Case 2: Monitor the temperature during operation to ensure it remains within acceptable limits. Document any deviations.
- Test Case 3: Confirm that the hold time is properly initiated and maintained. Compare against established criteria.
- Test Case 4: Review the PLC audit trail for completeness, ensuring all critical parameters are logged accurately.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality.
Approvals:
- Prepared By: [Insert Name]
- Reviewed By: [Insert Name]
- Approved By: [Insert Name]
Data Integrity Checks:
- Regular audits of PLC data to ensure no unauthorized changes.
- Verification of backup procedures for critical data.
- Cross-checking of manual logs against PLC data for consistency.