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 Sterility Test Isolator in NDDS Critical Analytics
Objective: To establish the design qualification requirements for the Sterility Test Isolator used in NDDS critical analytics to ensure compliance with regulatory standards.
Scope: This protocol applies to the Sterility Test Isolator utilized in the microbiology area for sterility testing of NDDS products, impacting product quality directly.
Responsibilities:
- Validation Team: Ensure compliance with validation protocols.
- Quality Assurance: Review and approve the DQ protocol.
- Microbiology Team: Perform sterility testing and provide necessary documentation.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) completed.
- Training of personnel on the operation of the Sterility Test Isolator.
Equipment Description:
The Sterility Test Isolator is a controlled environment system designed for sterility testing of NDDS products. It ensures a sterile working environment through effective airflow and leak integrity, with VHP cycles for decontamination.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001-01 | Leak Integrity Test | No leaks detected | Test report |
| DQ-001-02 | Airflow Verification | Airflow within specified range | Calibration certificate |
| DQ-001-03 | VHP Cycle Audit | Successful VHP cycle completion | Audit trail report |
Detailed Test Cases:
- Test Case 1: Perform a leak integrity test using a calibrated leak detector. Document results.
- Test Case 2: Measure airflow using an anemometer to ensure compliance with specifications. Record data.
- Test Case 3: Execute a VHP cycle and verify through the audit trail that all parameters were met.
Deviations: Any deviations from the acceptance criteria must be documented and justified. A deviation report should be generated and reviewed by the Quality Assurance team.
Approvals:
- Validation Team Lead: ____________________ Date: ___________
- Quality Assurance Representative: ____________________ Date: ___________
Data Integrity Checks:
- Ensure all data recorded during testing is backed up and securely stored.
- Verify that audit trails for VHP cycles are intact and accessible.
- Cross-verify test results with electronic records for consistency.