OUR COURSES

Sterilizing filter validation

OUR COURSES

Module length  
1 Day 
Learning tools  
Presentations, Lectures, Case Studies, Discussion, Question & Answers session, Final Evaluation Test

 

Target audience  
Quality Assurance, Quality Control, Regulatory Affairs, Technology Transfer, Validation, R&D

Agenda

International Regulatory Context

Requirements (PDA, EMA, EU Annex 1, ISO 13408-2, and USA-FDA guideline on aseptic processing)

Filter and Filtration process definition
Vendors and User Responsibility
Process Validation Studies
Process Review
Validation Test Overview
  • Bacterial Retention Studies
  • Compatibility
  • Adsorption
  • Extractables & Leachables
  • Product Wet Integrity Test (PWIT)
Toxicological Risk Assessment
Bracketing and Grouping
Process Revalidation
Future Regulatory Trends :
  • EU-Annex 1 revision contents – PUPSIT, Redundant filtration, CCS and Filtration System

Regulatory & technical references

  • Eu cGMP Annex 1
  • FDA Guidance for Aseptic Processing
  • USP 37 NF 29 <1229>
  • ASTM F838
  • ICH Q7
  • PDA TR 26 “Sterilizing Filtration of Liquids”
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