Equipment Validation SOP for Microfluidic Mixer in Liposome and LNP Formation
Purpose: This SOP outlines the validation process for the Microfluidic Mixer used in the formation of liposomes and lipid nanoparticles, ensuring compliance with regulatory requirements and product quality standards.
Scope: This procedure applies to the Microfluidic Mixer utilized in R&D and Production areas for controlled nanoparticle formation, impacting product quality directly.
Definitions:
- NDDS: Novel Drug Delivery Systems
- LNP: Lipid Nanoparticles
- CSV: Computer Software Validation
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
Roles:
- Validation Team: Responsible for executing and documenting validation activities.
- Quality Assurance: Ensures compliance with regulatory standards and reviews validation documentation.
- Equipment Owner: Maintains equipment and ensures adherence to SOPs.
Lifecycle Procedure:
- Design Qualification (DQ): Assess the design specifications to ensure they meet user requirements.
- Installation Qualification (IQ): Verify that the Microfluidic Mixer is installed correctly and according to manufacturer specifications.
- Operational Qualification (OQ): Validate that the equipment operates within specified limits and performs as intended.
- Performance Qualification (PQ): Confirm that the equipment consistently produces outputs that meet predefined quality criteria.
GDP Controls: Good Documentation Practices must be followed throughout the validation process, ensuring all records are accurate, complete, and legible.
Acceptance Criteria Governance: Acceptance criteria will adhere to URS Annex 11 and Annex 15 guidelines, ensuring compliance with regulatory expectations.
Calibration/PM Governance: The Microfluidic Mixer must undergo regular calibration and preventive maintenance as per the manufacturer’s specifications and internal policies.
Change Control Triggers: Any changes to the equipment, processes, or operating procedures must initiate a change control process to assess impact and necessary validation activities.
Revalidation Triggers and Periodic Review: Revalidation is required annually or in response to significant changes or deviations that could affect equipment performance.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Certificates
- Change Control Documentation
- Maintenance Logs