HVAC Systems in Pharmaceutical Industry – Part 2

About the Course

This eLearning course focuses on the qualification and lifecycle management of HVAC systems in GMP-regulated pharmaceutical environments. It covers system design considerations, DQ/IQ/OQ/PQ phases, risk-based approaches, change control, and ongoing performance monitoring. The course emphasizes regulatory expectations and best practices for maintaining a state of control throughout the HVAC system lifecycle.

Content

Qualification and Lifecycle Management of HVAC Systems

• Qualification concepts
  • Phases of Commissioning & Qualification
  • Qualification of HVAC
  • Installation Qualification (IQ): Elements, Documentation and Compliance
  • Operational Qualification (OQ) & Performance Qualification (PQ) Tests
  • HEPA filter integrity test
  • Non-Viable particulate counts test
  • Viable particle counts test
  • Air Velocity Test
  • Air Changes Per Hour
  • Area Recovery Test
  • Airflow visualization test
• Lifecycle management
  • Periodic Validation of HVAC
  • Preventive Maintenance Procedures and Frequency
  • External Vendor and HVAC Qualifications
• Regulatory actions
  • Citations
  • Auditing HVAC Systems and Cleanrooms
  • Next steps for drug inspectors and regulators

Summary and Conclusion: Life cycle management of of HVAC Systems

Final Evaluation: 3 attempts to achieve 70% in the evaluation.