Tag: Annex 15

Coding/Printing Machine (Inkjet/Laser) – IQ Protocol

Document Control: Document Number: IQ-001 Version: 1.0 Effective Date: [Insert Date] Reviewed By: [Insert Name] Approval Date: [Insert Date] Installation Qualification Protocol for Coding/Printing Machine in IV Infusions Objective: To establish and document the Installation Qualification (IQ) for the Coding/Printing…

Coding/Printing Machine (Inkjet/Laser) – DQ Protocol

Document Control Document Number: DQ-CPM-001 Version: 1.0 Effective Date: [Insert Date] Reviewed By: [Insert Name] Approval Date: [Insert Date] Design Qualification Protocol for Coding/Printing Machine in IV Infusions Meta Description: This document outlines the Design Qualification Protocol for the Coding/Printing…

Coding/Printing Machine (Inkjet/Laser) – Equipment Validation SOP

Standard Operating Procedure for Equipment Validation of Coding/Printing Machines Purpose: The purpose of this SOP is to outline the validation process for Coding/Printing Machines (Inkjet/Laser) used in the packaging of IV Infusions, ensuring compliance with regulatory requirements and maintaining product…

Device Inspection System (Vision/Microscopy) – Deviation Impact Assessment

Deviation Impact Assessment Equipment Information Equipment: Device Inspection System (Vision/Microscopy) Area: QC/R&D Criticality: Critical Product Impact: Direct CSV Required: Yes Deviation Details Description: [Insert deviation description here] Date of Deviation: [Insert date] Reported By: [Insert name] Classification Type: [Insert classification…

Device Inspection System (Vision/Microscopy) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Device Inspection System (Vision/Microscopy) Subcategory: NDDS – Drug-Eluting Stents / Coated Devices Area: QC/R&D DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs approved URS approved RA approved Calibration/PM Status Verification Calibration status verified PM…

Device Inspection System (Vision/Microscopy) – PQ Protocol

Document Control Number: PQ-ED-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Performance Qualification Protocol for Device Inspection System in NDDS – Drug-Eluting Stents This document outlines the Performance Qualification (PQ) protocol for the Device Inspection System used…

Device Inspection System (Vision/Microscopy) – OQ Protocol

Document Control Protocol Number: OQ-DEV-INS-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Prepared By: [Name] Approved By: [Name] Operational Qualification Protocol for Device Inspection System Objective: To validate the Device Inspection System for inspecting coating defects and…