Standard Operating Procedure for Validation of Tangential Flow Filtration System
Purpose: This SOP outlines the validation process for the Tangential Flow Filtration (TFF) System used in R&D and production for buffer exchange and concentration, ensuring compliance with regulatory standards and product quality.
Scope: This procedure applies to the Tangential Flow Filtration System utilized in the development and production of NDDS – Liposomes & Lipid Nanoparticles (LNP) within the R&D and production areas.
Definitions:
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- CSV: Computerized System Validation
- URS: User Requirements Specification
Roles:
- Validation Team: Responsible for overseeing the validation process.
- Quality Assurance: Ensures compliance with regulatory requirements.
- Operations: Conducts equipment operation and maintenance.
Lifecycle Procedure:
- Design Qualification (DQ): Assess user requirements and specifications.
- Installation Qualification (IQ): Verify installation and configuration of the TFF System.
- Operational Qualification (OQ): Validate operational parameters and performance under normal conditions.
- Performance Qualification (PQ): Confirm system performance meets product requirements.
GDP Controls: Good Documentation Practices must be followed throughout the validation process, ensuring all documentation is complete, accurate, and traceable.
Acceptance Criteria Governance: Acceptance criteria must comply with URS, Annex 11, and Annex 15, ensuring that all system performance metrics are met.
Calibration/PM Governance: Regular calibration and preventive maintenance must be scheduled and documented to ensure continuous compliance and performance of the TFF System.
Change Control Triggers: Any changes to the TFF System, including modifications or upgrades, must initiate a change control process to assess impact and revalidation requirements.
Revalidation Triggers and Periodic Review: Revalidation is required every 12 months, or upon significant changes to the system or process, to ensure ongoing compliance and performance.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Certificates
- Change Control Documentation
- Maintenance Logs