Tag: Annex 15

VHP Decontamination Unit (if isolator/RABS) – Deviation Impact Assessment

Deviation Impact Assessment Equipment Details Equipment: VHP Decontamination Unit (if isolator/RABS) Area: Production Criticality: Critical Product Impact: Direct CSV Required: Yes Deviation Details Deviation Description: [Enter deviation description here] Date of Deviation: [Enter date here] Reported By: [Enter name here]…

VHP Decontamination Unit (if isolator/RABS) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: VHP Decontamination Unit Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments) Area: Production DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes CSV Required: Yes Pre-Start Training completed SOPs reviewed and approved User Requirements Specification (URS) approved Regulatory Affairs (RA) approval obtained Calibration/PM Status…

VHP Decontamination Unit (if isolator/RABS) – PQ Protocol

Performance Qualification Protocol for VHP Decontamination Unit in Ophthalmics Document Number: PQ-001 Version: 1.0 Date: [Insert Date] Prepared by: [Insert Name] Approved by: [Insert Name] Objective The objective of this Performance Qualification (PQ) protocol is to validate the performance of…

VHP Decontamination Unit (if isolator/RABS) – OQ Protocol

Document Control Protocol Number: OQ-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Prepared By: [Insert Name] Approved By: [Insert Name] Operational Qualification Protocol for VHP Decontamination Unit Meta Description: This document outlines the Operational Qualification protocol for…

VHP Decontamination Unit (if isolator/RABS) – IQ Protocol

Installation Qualification Protocol for VHP Decontamination Unit in Ophthalmics Document Control: Document Number: IQ-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Objective The objective of this Installation Qualification (IQ) protocol is to verify that the VHP Decontamination…

VHP Decontamination Unit (if isolator/RABS) – DQ Protocol

Document Control Number: DQ-OPH-001 Version: 1.0 Effective Date: YYYY-MM-DD Reviewed By: [Name] Approved By: [Name] Design Qualification Protocol for VHP Decontamination Unit in Ophthalmics Production Meta Description: This document outlines the Design Qualification Protocol for the VHP Decontamination Unit used…

VHP Generator / Decontamination Unit – Qualification Certificate Template

Qualification Certificate Equipment: VHP Generator / Decontamination Unit Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP) Area: Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Date [Execution Date] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary Line] Overall…