Annex 15 – Page 53 – Pharma Validation

Isolator / RABS (NDDS Filling) – 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 Verify leak integrity of the isolator H DQ-001 IQ-001 OQ-001 PQ-001 Leak Integrity Test Report Pass URS-002 Ensure glove…

Isolator / RABS (NDDS Filling) – Validation Summary Report (VSR) Template

Validation Summary Report (VSR) Summary This Validation Summary Report (VSR) outlines the validation activities and results for the Isolator / RABS used in the production of NDDS, specifically focusing on Liposomes and Lipid Nanoparticles (LNP). Scope and Boundaries The scope…

Isolator / RABS (NDDS Filling) – Deviation Impact Assessment

Deviation Impact Assessment Template Equipment Details Equipment: Isolator / RABS (NDDS Filling) 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] Reported By:…

Isolator / RABS (NDDS Filling) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Isolator / RABS (NDDS Filling) Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP) Area: Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Checks Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration status…

Isolator / RABS (NDDS Filling) – PQ Protocol

Document Number: PQ-001 Version: 1.0 Effective Date: YYYY-MM-DD Review Date: YYYY-MM-DD Prepared by: [Your Name] Approved by: [Approver’s Name] Performance Qualification Protocol for Isolator/RABS in NDDS Filling Meta Description: This document outlines the Performance Qualification (PQ) protocol for Isolator/RABS used…

Isolator / RABS (NDDS Filling) – OQ Protocol

Document Control: Protocol Number: OQ-001 Version: 1.0 Effective Date: [Insert Date] Reviewed by: [Insert Name] Approved by: [Insert Name] Operational Qualification Protocol for Isolator/RABS in NDDS Filling Meta Description: This document outlines the Operational Qualification (OQ) protocol for the Isolator/RABS…

Isolator / RABS (NDDS Filling) – IQ Protocol

Document Control Document ID: IQ-ISOLATOR-NDDS-001 Version: 1.0 Effective Date: [Insert Date] Prepared By: [Insert Name] Reviewed By: [Insert Name] Approved By: [Insert Name] Installation Qualification Protocol for Isolator/RABS in NDDS Filling Meta Description: This Installation Qualification (IQ) Protocol outlines the…

Isolator / RABS (NDDS Filling) – DQ Protocol

Document Control Document ID: DQ-ISOL-RABS-001 Version: 1.0 Effective Date: YYYY-MM-DD Reviewed by: [Reviewer Name] Approval: [Approver Name] Design Qualification Protocol for Isolator/RABS in NDDS Filling Meta Description: This document outlines the Design Qualification Protocol for Isolator/RABS used in NDDS Filling,…

Isolator / RABS (NDDS Filling) – Equipment Validation SOP

Standard Operating Procedure for Equipment Validation of Isolator/RABS in NDDS Filling Purpose: To establish a comprehensive procedure for the validation of Isolator/RABS equipment used in the aseptic filling of NDDS, specifically focusing on liposomes and lipid nanoparticles. Scope: This SOP…

Pump Assembly Machine (Nasal) – Qualification Certificate Template

Qualification Certificate Equipment: Pump Assembly Machine (Nasal) Subcategory: Nasal & Otic Products (Sterile / Non-Sterile) Area: Production Equipment Identifier [INSERT EQUIPMENT IDENTIFIER] Protocol Reference [INSERT PROTOCOL REFERENCE] Execution Dates [INSERT EXECUTION DATES] Calibration Status [INSERT CALIBRATION STATUS] Deviations Summary [INSERT…