Validation of HVAC and controlled environments for manufacturing operations

Course Details

Module length  
from 1 day and half to 2 days
Learning tools  
Presentations, Lectures, Case Studies, Discussion, Question & Answers session, Final evaluation test


Target audience  
Manufacturing, Quality Assurance, Validation, Engineering, Maintenance


Regulatory aspect from International Agencies (e.g. EMA, USA-FDA, ISO-14644)
Technical Background from cGEP (Good Engineering Practices)
Validation Life Cycle
  • Design Qualification
  • Installation Qualification
  • Instruments Calibration 
  • Operational Qualification
  • Performance Qualification
Operational and Maintenance Aspects
Inspection points to consider from DOC experience
Case Studies from DOC experience

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”

Do you have any questions?