Annex 15 – Page 21 – Pharma Validation

NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF) – OQ Protocol

Document Control Document Number: OQ-001 Revision: 1.0 Date: 2023-10-01 Prepared By: Validation Team Approved By: QA Manager Operational Qualification Protocol for NDDS Process Control System Objective: To validate the NDDS Process Control System (PLC/SCADA) to ensure it meets the specified…

NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF) – IQ Protocol

Document Control Number: IQ-NDDS-PLC-001 Version: 1.0 Effective Date: [Insert Date] Prepared by: [Name] Approved by: [Name] Installation Qualification Protocol for NDDS Process Control System Meta Description: This document outlines the Installation Qualification (IQ) protocol for the NDDS Process Control System,…

NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF) – DQ Protocol

Document Control: Document ID: DQ-NDDS-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Design Qualification Protocol for NDDS Process Control System Meta Description: This document outlines the Design Qualification Protocol for the NDDS Process Control System, ensuring compliance…

NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF) – Equipment Validation SOP

Standard Operating Procedure for Validation of NDDS Process Control System Purpose: To establish a comprehensive procedure for the validation of the NDDS Process Control System, ensuring compliance with regulatory standards and maintaining data integrity throughout the product lifecycle. Scope: This…

Automated Visual Inspection (AVI) System – Qualification Certificate Template

Qualification Certificate Equipment Details Equipment: Automated Visual Inspection (AVI) System Subcategory: NDDS – NDDS Packaging & Integrity Area: Production Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: Yes Qualification Details Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference] Execution…

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…