Design Qualification Protocol for Extrusion System in NDDS

Objective

The objective of this Design Qualification (DQ) Protocol is to ensure that the Extrusion System (Liposome Extruder) is suitable for its intended purpose in the production of liposomes and lipid nanoparticles, specifically for size control via membrane extrusion.

Scope

This protocol applies to the Design Qualification of the Extrusion System utilized in the R&D and production areas for the formulation of NDDS involving liposomes and lipid nanoparticles.

Responsibilities

The following roles are responsible for the execution and approval of this DQ Protocol:

• Validation Team: Responsible for protocol execution and documentation.
• Quality Assurance: Responsible for review and approval of the protocol.
• Engineering: Responsible for equipment maintenance and technical support.

Prerequisites

Prior to executing this protocol, the following prerequisites must be met:

• Equipment installation and operational qualification must be completed.
• Relevant Standard Operating Procedures (SOPs) must be established and available.
• Training for personnel operating the equipment must be completed.

Equipment Description

The Extrusion System (Liposome Extruder) is designed for size control via membrane extrusion. It operates under defined pressure and temperature conditions to ensure the desired quality of liposomes and lipid nanoparticles.

Test Plan

Detailed Test Cases

Test Case 1: Verify pressure settings during extrusion.

Procedure: Set the equipment to the specified pressure and record the actual pressure. Compare with acceptance criteria.

Test Case 2: Check membrane pore size.

Procedure: Measure the membrane pore size using appropriate methods and compare with specifications.

Test Case 3: Monitor temperature during operation.

Procedure: Continuously monitor the temperature during extrusion and record the data.

Test Case 4: Evaluate flow rate during extrusion.

Procedure: Measure the flow rate during operation and validate against specifications.

Deviations

Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be implemented as necessary.

Approvals

This protocol must be approved by the Quality Assurance and Validation Teams prior to execution.

Data Integrity Checks

As CSV is required, the following data integrity checks will be performed:

• Ensure all critical parameters are logged accurately during the testing process.
• Verify that data records are backed up and securely stored.
• Implement access controls to prevent unauthorized changes to critical data.