RESEARCH OF THE SCOPE OF TESTING REQUIRED FOR QUALIFICATION OF THE HVAC SYSTEM

Abstract

In the pharmaceutical industry, HVAC system qualification is carried out by applying a risk management model in accordance to relevant GMP requirements. Qualification of these systems is an integral part of quality assurance and represents a systemic approach of data collection and data analysis that will provide documentary evidence that the system works properly and continuously gives the expected results. GMP requires identifying the extent of the qualification required to ensure reliability and compliance with GMP principles based on the outcome of the risk assessment. This paper provides an example of risk assessment approach using the FMEA method. Potential risks were identified, it was estimated which risks were considered acceptable, and risk reduction actions were proposed, from their impact on the HVAC system.

Keywords

• qualification
• fmea
• hvac