Contamination Control Strategy

Course content

Regulatory Point

• European and American Regulations:
  • European GMP – “New draft of Annex 1 Manufacture of Sterile Medicinal Products (February 2020)”
  • American GMP – FDA “Guidance for Industry Sterile Drug Products Produced by Aseptic processing – Current Good Manufacturing Practice (September 2004)”
• The different contaminants:
  • Particles and microorganisms
• The general functions in a classified area:
  • HVAC, aeraulic schemes, airlocks,…
• Classification and monitoring of classified areas
• New draft of Annex 1:
  • Expectations for the Contamination Control Strategy
• ICH Q9 :
  • FMEA Tool
• FMEA Tool used to manage your Contamination Control Strategy :
  • The different Failure Mode Effects to take into account
• Example of an approach:
  • Feedback on a concrete case for a production area

Learning objectives

• Understanding of the expectations described in the new draft of the Annex 1 published on February 2020
• Deepen the knowledg about the different potential contaminants in contact with the sterile drugs produced in your classified areas.
• Master the aseptic practices needed in your own activity
• Ability to make troubleshooting in order to manage investigation linked to a microbiological issue.
• Ability to manage Trends Analysis of Environmental Monitoring

Who should attend

This training is intended for Production Managers, Quality Support Managers, Microbiological Laboratory Managers, Sterility Assurance Managers and Qualified Persons with a minimum experience of 5 years in the life science industry.

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