Standard Operating Procedure for the Validation of Sterile Filtration Skid
Purpose: This SOP outlines the procedures for the validation of the Sterile Filtration Skid used in the production of NDDS, specifically for Liposomes and Lipid Nanoparticles (LNP).
Scope: This procedure applies to the validation lifecycle of the Sterile Filtration Skid within the production area, ensuring compliance with regulatory requirements and product quality standards.
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 executing validation activities.
- Quality Assurance: Ensures compliance with SOPs and regulatory standards.
- Production Personnel: Operate the equipment and provide necessary documentation.
Lifecycle Procedure:
- Design Qualification (DQ): Document user requirements and specifications.
- Installation Qualification (IQ): Verify installation against specifications.
- Operational Qualification (OQ): Validate operational parameters.
- Performance Qualification (PQ): Confirm performance under actual conditions.
GDP Controls: Good Documentation Practices must be adhered to throughout the validation process, including clear, legible, and accurate records.
Acceptance Criteria Governance: Acceptance criteria should align with URS, Annex 1, and Annex 11 guidelines, ensuring that all critical parameters meet predefined specifications.
Calibration/PM Governance: Calibration and preventive maintenance must be performed as per the manufacturer’s recommendations and documented accordingly.
Change Control Triggers: Any changes to the equipment, processes, or procedures must be evaluated for impact on validation status and documented through a change control process.
Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or when significant changes occur that may affect equipment performance.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Records
- Change Control Documentation
- Periodic Review Records