Tangential Flow Filtration (TFF) System – Equipment Validation SOP

Standard Operating Procedure for Validation of Tangential Flow Filtration System

Purpose: This SOP outlines the validation process for the Tangential Flow Filtration (TFF) System used in R&D and production for buffer exchange and concentration, ensuring compliance with regulatory standards and product quality.

Scope: This procedure applies to the Tangential Flow Filtration System utilized in the development and production of NDDS – Liposomes & Lipid Nanoparticles (LNP) within the R&D and production areas.

Definitions:

  • DQ: Design Qualification
  • IQ: Installation Qualification
  • OQ: Operational Qualification
  • PQ: Performance Qualification
  • CSV: Computerized System Validation
  • URS: User Requirements Specification

Roles:

  • Validation Team: Responsible for overseeing the validation process.
  • Quality Assurance: Ensures compliance with regulatory requirements.
  • Operations: Conducts equipment operation and maintenance.

Lifecycle Procedure:

  1. Design Qualification (DQ): Assess user requirements and specifications.
  2. Installation Qualification (IQ): Verify installation and configuration of the TFF System.
  3. Operational Qualification (OQ): Validate operational parameters and performance under normal conditions.
  4. Performance Qualification (PQ): Confirm system performance meets product requirements.

GDP Controls: Good Documentation Practices must be followed throughout the validation process, ensuring all documentation is complete, accurate, and traceable.

Acceptance Criteria Governance: Acceptance criteria must comply with URS, Annex 11, and Annex 15, ensuring that all system performance metrics are met.

Calibration/PM Governance: Regular calibration and preventive maintenance must be scheduled and documented to ensure continuous compliance and performance of the TFF System.

See also  Suppository Leak Test Machine – Qualification Execution Checklist

Change Control Triggers: Any changes to the TFF System, including modifications or upgrades, must initiate a change control process to assess impact and revalidation requirements.

Revalidation Triggers and Periodic Review: Revalidation is required every 12 months, or upon significant changes to the system or process, to ensure ongoing compliance and performance.

Records/Attachments List:

  • Validation Protocols
  • Validation Reports
  • Calibration Certificates
  • Change Control Documentation
  • Maintenance Logs

Also Check:

Ophthalmic Filling Machine (Dropper Bottles) – Qualification Execution Checklist

Qualification Execution Checklist for Ophthalmic Filling Machine (Dropper Bottles) Equipment Details Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments) Area: Production DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Checks Training completed SOPs reviewed and approved URS approved Regulatory Affairs approved Calibration/PM Status Verification…

DPI – Deviation Impact Assessment

Deviation Impact Assessment Template Equipment Details Equipment: DPI Area: MDI Bulk Compounding Vessel (Jacketed SS) Criticality: Prepare suspension/solution for MDI Product Impact: Production CSV Required: Yes Deviation Details Description of Deviation: [Insert detailed description of the deviation] Date of Deviation:…

IV Bag Form-Fill-Seal (FFS) Machine – Deviation Impact Assessment

Deviation Impact Assessment Equipment Details Equipment: IV Bag Form-Fill-Seal (FFS) Machine Area: Production Criticality: Critical Product Impact: Direct CSV Required: Yes Deviation Details Description of Deviation: [Insert detailed description of the deviation] Date of Deviation: [Insert date] Classification Deviation Classification:…