Annex 15 – Page 129 – Pharma Validation

Tangential Flow Filtration (TFF) System – Traceability Matrix (URS ↔ Tests)

URS ID URS Statement Risk (H/M/L) DQ Test Ref IQ Test Ref OQ Test Ref PQ Test Ref Evidence/Record Result URS-001 Ensure TMP is maintained within specified limits during operation. H DQ-001 IQ-001 OQ-001 PQ-001 TMP Log [Pass/Fail] URS-002 Verify…

Tangential Flow Filtration (TFF) System – Validation Summary Report (VSR) Template

Validation Summary Report (VSR) Equipment: Tangential Flow Filtration (TFF) System Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP) Area: R&D/Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes Acceptance Criteria Reference: URS Annex11 Annex15 Requalification Frequency: 12M Summary This Validation Summary Report outlines the validation…

Tangential Flow Filtration (TFF) System – Deviation Impact Assessment

Deviation Impact Assessment Template Equipment: Tangential Flow Filtration (TFF) System Area: R&D/Production Criticality: Critical Product Impact: Direct CSV Required: Yes Deviation Details Description: [Insert detailed description of the deviation] Date of Deviation: [Insert date] Reported By: [Insert name] Classification Type:…

Tangential Flow Filtration (TFF) System – Qualification Execution Checklist

Qualification Execution Checklist for Tangential Flow Filtration (TFF) System Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP) Area: R&D/Production DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes CSV Required: Yes Pre-Start Checks Training completed SOPs reviewed and approved User Requirements Specification (URS) approved Regulatory Affairs (RA)…

Tangential Flow Filtration (TFF) System – PQ Protocol

Document Number: PQ-TFF-001 Version: 1.0 Effective Date: YYYY-MM-DD Reviewed By: [Name] Approved By: [Name] Performance Qualification Protocol for Tangential Flow Filtration System Meta Description: This document outlines the Performance Qualification (PQ) protocol for the Tangential Flow Filtration (TFF) System used…

Tangential Flow Filtration (TFF) System – OQ Protocol

Document Control Document ID: OQ-TFF-001 Version: 1.0 Date: 2023-10-01 Prepared by: [Your Name] Reviewed by: [Reviewer Name] Operational Qualification Protocol for Tangential Flow Filtration System Meta Description: This document outlines the Operational Qualification (OQ) protocol for the Tangential Flow Filtration…

Tangential Flow Filtration (TFF) System – IQ Protocol

Installation Qualification Protocol for Tangential Flow Filtration System Document Control Number: IQ-TFF-001 Version: 1.0 Effective Date: [Insert Date] Reviewed by: [Insert Name] Approved by: [Insert Name] Objective The objective of this Installation Qualification (IQ) Protocol is to verify that the…

Tangential Flow Filtration (TFF) System – DQ Protocol

Document Control Document Number: DQ-TFF-001 Version: 1.0 Date: 2023-10-01 Prepared By: [Your Name] Approved By: [Approver’s Name] Design Qualification Protocol for Tangential Flow Filtration System Meta Description: This document outlines the Design Qualification Protocol for the Tangential Flow Filtration System,…

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…

Inline Heater / Heat Exchanger – Qualification Certificate Template

Qualification Certificate Equipment: Inline Heater / Heat Exchanger Subcategory: IV Infusions (LVP/SVP – Bags/Bottles) Area: Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Date [Execution Date] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary] Overall Qualification Statement [Overall…