HVAC and Controlled Enviroments

Module Lenght

from 1 day and half to 2 days

Agenda

  • Regulatory aspect from International Agencies
  • Technical Background from cGEP (Good Engineering Procedures)
  • Validation Life Cycle
    • Design Qualification
    • Installation Qualification
    • Operational Qualification
    • Calibration
    • Performance Qualification
  • Operational and Maintenance Aspects

Target audience

  • Manufacturing
  • Quality Assurance
  • Validation
  • Engineering
  • Maintenance

Learning tools

  • Presentations
  • Lectures
  • Case Studies
  • Discussion
  • Question & Answers session
  • Final evaluation test

Regulatory & technical references

  • EU GMP Annex 1: “Manufacture of sterile medicinal products”
  • WHO TRS 961 Annex 5: “WHO guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms”
  • WHO TRS 961 Annex 6: “WHO good manufacturing practices for sterile pharmaceutical products”
  • PIC/S Code of GMP PE009-11 Annex 1: “Manufacture of sterile medicinal products”
  • USP <1116> Microbiological Control And Monitoring Of Aseptic Processing Environments
  • ISO 14644-1 “Classification of air cleanliness by particle concentration”
  • ISO 14644-2 “Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration”
  • UNI EN ISO 14644-3 “Cleanrooms and associated controlled environments: Test methods”
  • ISPE Good Practice Guide “Heating, Ventilation and Air Conditioning (HVAC)”
  • FDA “Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice”
  • PDA – TR 13 Technical Report No. 13 “Fundamentals of an Environmental Monitoring Program “
  • PDA “Points to Consider for Aseptic Processing – Part 1”

Number of trainers

One

Tailoring option available

No

Final evaluation quiz

Yes

Contact

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