Document Control:
Document Number: DQ-ISFS-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Design Qualification Protocol for Inline Sterile Filtration Skid
Meta Description: This document outlines the Design Qualification Protocol for the Inline Sterile Filtration Skid used in the production of sterile powders and lyophilized products.
Tags: Equipment Validation, DQ Protocol, Inline Sterile Filtration, Sterile Products
Objective
The objective of this Design Qualification (DQ) protocol is to establish documented evidence that the Inline Sterile Filtration Skid is designed and installed in accordance with user requirements and applicable regulatory standards.
Scope
This protocol applies to the Inline Sterile Filtration Skid utilized in the production area for sterilizing filtration prior to the filling of sterile powders and lyophilized products, impacting the product directly.
Responsibilities
- Validation Team: Responsible for the execution of the protocol and documentation of results.
- Quality Assurance: Responsible for review and approval of the DQ protocol and results.
- Production Team: Responsible for the operation of the Inline Sterile Filtration Skid during testing.
Prerequisites
- Completion of User Requirement Specification (URS).
- Installation of Inline Sterile Filtration Skid in the production area.
- Training of personnel on equipment operation and validation procedures.
Equipment Description
The Inline Sterile Filtration Skid is a system designed for sterilizing filtration of products prior to filling. The equipment ensures the removal of microorganisms and particles to maintain product sterility.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Flow DP integrity audit trail logs verification. | Logs must show no integrity failures. | Audit trail logs report. |
Detailed Test Cases
Test Case T1: Flow DP Integrity Audit Trail Logs Verification
Objective: To ensure that the integrity of the filtration process is maintained.
Procedure: Review the audit trail logs generated during operation for any integrity failures.
Acceptance Criteria: No integrity failures should be recorded in the logs.
Expected Results: All logs indicate successful filtration without failures.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed. A corrective action plan will be developed to address any identified issues.
Approvals
Prepared by: [Name] – Validation Team
Reviewed by: [Name] – Quality Assurance
Approved by: [Name] – Management
Data Integrity Checks
As CSV is required, the following practical data integrity checks will be implemented:
- Regular backups of audit trail logs.
- Access controls to ensure only authorized personnel can modify logs.
- Periodic review of logs for anomalies or unauthorized changes.