Document Number: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Reviewer Name]
Approval Date: [Approval Date]
Design Qualification Protocol for Sterile Filtration Skid in NDDS
Meta Description: This document outlines the Design Qualification (DQ) protocol for the Sterile Filtration Skid used in NDDS – Liposomes & Lipid Nanoparticles equipment validation.
Tags: Equipment Validation, NDDS, Liposomes, Lipid Nanoparticles, Sterile Filtration
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Sterile Filtration Skid is designed and installed in accordance with the specified requirements and is suitable for its intended use in the production of NDDS, specifically Liposomes and Lipid Nanoparticles.
Scope
This protocol applies to the Sterile Filtration Skid used for sterilizing filtration in the production area for NDDS. It covers the critical aspects of equipment validation, including design specifications, installation qualifications, and operational qualifications.
Responsibilities
- Validation Team: Ensure compliance with validation protocols and documentation.
- Quality Assurance: Review and approve the DQ protocol and associated documents.
- Production Team: Operate the equipment in accordance with the established procedures.
Prerequisites
- Completion of User Requirement Specification (URS).
- Approval of project initiation documents.
- Availability of qualified personnel for equipment operation.
Equipment Description
The Sterile Filtration Skid is a system designed for the sterilizing filtration of NDDS, specifically Liposomes and Lipid Nanoparticles. It includes the following key features:
- Flow DP integrity audit trail
- Automated control systems
- Real-time monitoring capabilities
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T001 | Verify installation against design specifications. | All components installed as per URS Annex1 Annex11. | Installation Verification Report. |
| T002 | Perform flow DP integrity test. | Integrity test results meet defined standards. | Test Report and Audit Trail. |
Detailed Test Cases
Test ID: T001
Procedure: Verify that all components of the Sterile Filtration Skid are installed as per the design specifications outlined in the URS.
Acceptance Criteria: All components must match the specifications without any discrepancies.
Evidence: Documented Installation Verification Report signed by the validation team.
Test ID: T002
Procedure: Conduct a flow DP integrity test using the standard operating procedure.
Acceptance Criteria: The integrity test must show no breaches, with results documented in the audit trail.
Evidence: Integrity test report along with the audit trail documentation.
Deviations
Any deviations from the defined acceptance criteria must be documented and assessed for impact on the validation process. A deviation report should be generated and reviewed by the Quality Assurance team.
Approvals
This Design Qualification Protocol must be reviewed and approved by the following stakeholders:
- Validation Team Lead
- Quality Assurance Manager
- Production Manager