Tag: ICH Q9

CCIT System (Vacuum Decay/Helium/HVLD) – PQ Protocol

Document Control Number: PQ-CCIT-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Performance Qualification Protocol for CCIT System in Ophthalmics This document outlines the Performance Qualification (PQ) protocol for the Container Closure Integrity Testing (CCIT) System used in…

CCIT System (Vacuum Decay/Helium/HVLD) – OQ Protocol

Document Control Number: OQ-CCIT-001 Version: 1.0 Date: [Insert Date] Prepared by: [Insert Name] Approved by: [Insert Name] Operational Qualification Protocol for CCIT System in Ophthalmics Objective: To validate the CCIT System for ensuring container closure integrity of sterile eye drops…

CCIT System (Vacuum Decay/Helium/HVLD) – IQ Protocol

Document Control: Document ID: IQ-CCIT-001 Version: 1.0 Effective Date: [Insert Date] Reviewed by: [Insert Name] Approved by: [Insert Name] Installation Qualification Protocol for CCIT System in Ophthalmics Meta Description: This document outlines the Installation Qualification (IQ) protocol for the CCIT…

CCIT System (Vacuum Decay/Helium/HVLD) – DQ Protocol

Design Qualification Protocol for CCIT System in Ophthalmics Document Number: DQ-CCIT-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Prepared By: [Insert Name] Approved By: [Insert Name] Objective The objective of this Design Qualification (DQ) protocol is to…

CCIT System (Vacuum Decay/Helium/HVLD) – Equipment Validation SOP

Standard Operating Procedure for CCIT System Equipment Validation Equipment Validation, Ophthalmics, CCIT System, Quality Control, Production Purpose This SOP outlines the procedures for validating the Container Closure Integrity Testing (CCIT) System used in the production of sterile ophthalmic products, ensuring…

Ultracentrifuge – Qualification Certificate Template

Qualification Certificate Equipment: Ultracentrifuge Subcategory: NDDS – Polymeric Nanoparticles (PLGA etc.) Area: R&D/Production Equipment Identifier [Equipment Identifier] Protocol Reference [Protocol Reference] Execution Dates [Execution Dates] Calibration Status [Calibration Status] Deviations Summary [Deviations Summary Line] Overall Qualification Statement The Ultracentrifuge has…

Ultracentrifuge – 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 Ultracentrifuge must achieve specified RPM for particle separation. H DQ-001 IQ-001 OQ-001 PQ-001 Calibration Certificate URS-002 Ultracentrifuge must maintain…

Ultracentrifuge – Validation Summary Report (VSR) Template

Validation Summary Report (VSR) Equipment: Ultracentrifuge Subcategory: NDDS – Polymeric Nanoparticles (PLGA etc.) Area: R&D/Production Summary This Validation Summary Report (VSR) outlines the validation activities performed on the Ultracentrifuge utilized for the development and production of Polymeric Nanoparticles. The equipment…

Ultracentrifuge – Deviation Impact Assessment

Deviation Impact Assessment Equipment Information Equipment: Ultracentrifuge Area: R&D/Production Criticality: Critical Product Impact: Direct Deviation Details Description of Deviation: [Insert description of the deviation] Date of Deviation: [Insert date] Deviation Number: [Insert deviation number] Classification Classification: [Insert classification] Product/Patient Impact…

Ultracentrifuge – Qualification Execution Checklist

Qualification Execution Checklist for Ultracentrifuge Subcategory: NDDS – Polymeric Nanoparticles (PLGA etc.) Area: R&D/Production DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes Pre-start Checks Training completed SOPs reviewed and approved URS approved RA approved Calibration/PM Status Verification Calibration status verified Preventive Maintenance (PM) status verified Protocol…