Standard Operating Procedure for the Validation of Inline Static Mixer in NDDS

Purpose: This SOP outlines the validation process for the Inline Static Mixer utilized in the formation of Liposomes and Lipid Nanoparticles (LNP) in R&D and Production areas.

Scope: This procedure applies to the Inline Static Mixer used during the mixing process in the development and production of NDDS products, specifically Liposomes and LNP.

Definitions:

• NDDS: Novel Drug Delivery Systems
• LNP: Lipid Nanoparticles
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification

Roles:

• Validation Team: Responsible for the execution of validation activities.
• Quality Assurance: Ensures compliance with regulatory requirements and SOP adherence.
• Operations: Responsible for the operation and maintenance of the Inline Static Mixer.

Lifecycle Procedure:

1. Design Qualification (DQ): Define user requirements and ensure the design meets these requirements.
2. Installation Qualification (IQ): Verify that the Inline Static Mixer is installed correctly and according to specifications.
3. Operational Qualification (OQ): Assess the performance of the Inline Static Mixer under normal operating conditions.
4. Performance Qualification (PQ): Confirm that the Inline Static Mixer consistently performs as intended during actual production runs.

Good Documentation Practices (GDP) Controls: All validation documentation must be completed accurately and in real-time, ensuring traceability and compliance with GDP standards.

Acceptance Criteria Governance: Acceptance criteria will be defined in the User Requirements Specification (URS) and must be met during all qualification phases.

Calibration/PM Governance: The Inline Static Mixer must be calibrated and maintained according to the manufacturer’s specifications and internal maintenance schedules.

Change Control Triggers: Any modifications to the Inline Static Mixer or its operating procedures must undergo a formal change control process.

Revalidation Triggers and Periodic Review: Revalidation is required every 24 months or when significant changes occur in the process or equipment.

Records/Attachments List:

• User Requirements Specification (URS)
• Validation Protocols and Reports (DQ, IQ, OQ, PQ)
• Calibration Certificates
• Change Control Documentation
• Maintenance Logs