ICH Q9 – Page 4 – Pharma Validation

Automated Visual Inspection (AVI) 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 The AVI system shall detect particulate contaminants effectively. H DQ-001 IQ-001 OQ-001 PQ-001 Test Report AVI-001 URS-002 The AVI…

Automated Visual Inspection (AVI) System – Validation Summary Report (VSR) Template

Validation Summary Report (VSR) Equipment: Automated Visual Inspection (AVI) System Subcategory: NDDS – NDDS Packaging & Integrity Area: Production DQ/IQ/OQ/PQ Flags: Design Qualification (DQ): Yes Installation Qualification (IQ): Yes Operational Qualification (OQ): Yes Performance Qualification (PQ): Yes Acceptance Criteria Reference:…

Automated Visual Inspection (AVI) System – Deviation Impact Assessment

Deviation Impact Assessment Equipment Details Equipment: Automated Visual Inspection (AVI) System Area: Production Criticality: Critical Product Impact: Direct CSV Required: Yes Deviation Details Deviation Description: [Insert deviation description here] Date of Deviation: [Insert date] Classification Classification Level: [Insert classification level]…

Automated Visual Inspection (AVI) System – Qualification Execution Checklist

Qualification Execution Checklist for Automated Visual Inspection (AVI) System Subcategory: NDDS – NDDS Packaging & Integrity Area: Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Checks Training completed SOPs reviewed and approved User Requirements Specification (URS) approved Regulatory Approval (RA)…

Automated Visual Inspection (AVI) System – PQ Protocol

Document Control: Document Title: Performance Qualification Protocol for Automated Visual Inspection System Document Number: PQ-AVI-001 Version: 1.0 Effective Date: [Insert Date] Prepared By: [Insert Name] Approved By: [Insert Name] Performance Qualification Protocol for Automated Visual Inspection System Meta Description: This…

Automated Visual Inspection (AVI) System – OQ Protocol

Document Control Document Number: OQ-AVI-001 Version: 1.0 Effective Date: 2023-10-01 Review Date: 2024-10-01 Prepared By: [Your Name] Approved By: [Approver’s Name] Operational Qualification Protocol for Automated Visual Inspection System Meta Description: This document outlines the Operational Qualification protocol for the…

Automated Visual Inspection (AVI) System – IQ Protocol

Document Control Document Number: IQ-AVI-001 Version: 1.0 Effective Date: [Insert Date] Prepared By: [Insert Name] Approved By: [Insert Name] Installation Qualification Protocol for Automated Visual Inspection System Objective: To establish and document the Installation Qualification (IQ) of the Automated Visual…

Automated Visual Inspection (AVI) System – DQ Protocol

Document Control: Document Number: DQ-AVI-001 Version: 1.0 Effective Date: [Insert Date] Reviewed By: [Insert Name] Approval Date: [Insert Date] Design Qualification Protocol for Automated Visual Inspection System Objective: To establish a Design Qualification (DQ) protocol for the Automated Visual Inspection…

Automated Visual Inspection (AVI) System – Equipment Validation SOP

Standard Operating Procedure for Automated Visual Inspection System Validation Purpose: This SOP outlines the validation process for the Automated Visual Inspection (AVI) System used in NDDS Packaging and Integrity, ensuring compliance with regulatory requirements and maintaining product quality. Scope: This…

Sterility Test Isolator / System (if NDDS sterile) – Qualification Certificate Template

Qualification Certificate Equipment: Sterility Test Isolator / System Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP) Area: Microbiology Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary Line] Overall Qualification…