Ultrafiltration/Diafiltration (UF/DF) Skid – Equipment Validation SOP

Equipment Validation SOP for Ultrafiltration/Diafiltration Skid in NDDS

Meta Description: This SOP outlines the validation process for the Ultrafiltration/Diafiltration skid used in the purification of liposomes and lipid nanoparticles within R&D and production environments.

Tags: Equipment Validation, NDDS, Liposomes, Lipid Nanoparticles, Ultrafiltration, Diafiltration, R&D, Production

Purpose

The purpose of this SOP is to establish a standardized approach for the validation of the Ultrafiltration/Diafiltration (UF/DF) skid used in the purification and solvent exchange processes for liposomes and lipid nanoparticles.

Scope

This SOP applies to the validation of the UF/DF skid utilized in both Research & Development and Production areas, ensuring compliance with regulatory standards and maintaining the integrity of the product.

Definitions

  • UF/DF Skid: A system used for ultrafiltration and diafiltration processes.
  • Criticality: The significance of the equipment’s impact on product quality.
  • CSV: Computer System Validation.

Roles

  • Validation Team: Responsible for executing and documenting the validation activities.
  • Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.
  • Operations: Operates the equipment and provides input for validation processes.

Lifecycle Procedure

  1. Design Qualification (DQ)
  2. Installation Qualification (IQ)
  3. Operational Qualification (OQ)
  4. Performance Qualification (PQ)

GDP Controls

Good Documentation Practices (GDP) must be followed throughout the validation process to ensure traceability and compliance with regulatory requirements.

Acceptance Criteria Governance

Acceptance criteria will be established based on User Requirements Specification (URS) and Annex 11 compliance guidelines.

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Calibration/PM Governance

The equipment must be calibrated and maintained according to the manufacturer’s specifications and company policies to ensure reliable operation.

Change Control Triggers

Any changes to the equipment, process, or operating procedures must undergo a change control process to assess the impact on validation status.

Revalidation Triggers and Periodic Review

Revalidation is required annually or upon significant changes to the equipment or processes. A periodic review will be conducted to ensure ongoing compliance and performance.

Records/Attachments List

  • Validation Protocols
  • Validation Reports
  • Calibration Records
  • Change Control Documentation
  • Periodic Review Records

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