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