Standard Operating Procedure for Equipment Validation of Isolator/RABS in NDDS Filling
Purpose: To establish a comprehensive procedure for the validation of Isolator/RABS equipment used in the aseptic filling of NDDS, specifically focusing on liposomes and lipid nanoparticles.
Scope: This SOP applies to the validation process of Isolator/RABS equipment within the production area, ensuring compliance with regulatory standards and maintaining product integrity.
Definitions:
- Isolator: A contained system that provides an aseptic environment for the handling of sterile products.
- RABS: Restricted Access Barrier System that enhances aseptic processing by minimizing operator intervention.
- NDDS: Novel Drug Delivery Systems.
- CSV: Computer Software Validation.
Roles:
- Validation Team: Responsible for executing the validation protocol and ensuring compliance with SOPs.
- Quality Assurance: Ensures that validation activities meet regulatory requirements and internal standards.
- Production Staff: Operate the equipment and follow validated procedures during filling operations.
Lifecycle Procedure:
- Design Qualification (DQ): Document the intended use and specifications of the Isolator/RABS.
- Installation Qualification (IQ): Verify that the equipment is installed correctly and meets manufacturer specifications.
- Operational Qualification (OQ): Test the equipment under simulated conditions to ensure it operates as intended.
- Performance Qualification (PQ): Validate the equipment’s performance with actual production processes.
GDP Controls: Ensure Good Documentation Practices are followed throughout the validation process, including proper record-keeping and version control.
Acceptance Criteria Governance: Adhere to URS Annex 1 and Annex 11 requirements for equipment validation and performance criteria.
Calibration/PM Governance: Establish a calibration and preventive maintenance schedule to ensure compliance and optimal performance of the Isolator/RABS.
Change Control Triggers: Any modifications to the equipment, process, or environment that may impact validation status must be assessed and documented through the change control process.
Revalidation Triggers and Periodic Review: Revalidation is required annually or if significant changes occur. Conduct periodic reviews to ensure ongoing compliance and performance.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Records
- Change Control Documentation
- Periodic Review Reports