Performance Qualification Protocol for Sterile Filtration Skid in NDDS Production

Objective: To validate the performance of the Sterile Filtration Skid used in the production of NDDS – Liposomes & Lipid Nanoparticles, ensuring compliance with regulatory requirements.

Scope: This protocol applies to the Sterile Filtration Skid utilized for sterilizing filtration in the production area, impacting the quality of liposomal and lipid nanoparticle products.

Responsibilities:

• Validation Team: Execute the protocol and document results.
• Quality Assurance: Review and approve the protocol and results.
• Production Team: Ensure equipment is maintained and calibrated prior to testing.

Prerequisites:

• Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
• Training of personnel on equipment operation and safety procedures.
• Availability of all necessary materials and equipment for testing.

Equipment Description:

The Sterile Filtration Skid is designed for the sterilizing filtration of liposomal and lipid nanoparticle formulations. It includes a series of filters and pumps to ensure the integrity and sterility of the product.

Detailed Test Cases:

• Test Case ID: TC-001
  • Objective: Verify the integrity of the filtration process.
  • Procedure: Conduct a flow DP integrity audit during routine operation.
  • Expected Result: No breaches in integrity detected.
• Test Case ID: TC-002
  • Objective: Ensure proper function of the filtration skid under expected operating conditions.
  • Procedure: Simulate production conditions and monitor performance.
  • Expected Result: Equipment operates within specified parameters.

Deviations: Any deviations from the protocol must be documented and justified with corrective actions. All deviations must be reviewed and approved by the Quality Assurance team.

Approvals:

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Validation Team Lead

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Quality Assurance Manager