Research of the scope of testing required for qualification of the hvac system
Apstrakt
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.
Ključne reči:
Qualification / HVAC / FMEAIzvor:
Proceedings on Engineering Sciences, 2019, 1, 2, 553-562Izdavač:
- Faculty of Engineering, University of Kragujevac
Kolekcije
Institucija/grupa
Mašinski fakultetTY - JOUR AU - Tabašević, I. AU - Milanović, Dragan PY - 2019 UR - https://machinery.mas.bg.ac.rs/handle/123456789/3191 AB - 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. PB - Faculty of Engineering, University of Kragujevac T2 - Proceedings on Engineering Sciences T1 - Research of the scope of testing required for qualification of the hvac system EP - 562 IS - 2 SP - 553 VL - 1 DO - 10.24874/PES01.02.054 ER -
@article{ author = "Tabašević, I. and Milanović, Dragan", year = "2019", 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.", publisher = "Faculty of Engineering, University of Kragujevac", journal = "Proceedings on Engineering Sciences", title = "Research of the scope of testing required for qualification of the hvac system", pages = "562-553", number = "2", volume = "1", doi = "10.24874/PES01.02.054" }
Tabašević, I.,& Milanović, D.. (2019). Research of the scope of testing required for qualification of the hvac system. in Proceedings on Engineering Sciences Faculty of Engineering, University of Kragujevac., 1(2), 553-562. https://doi.org/10.24874/PES01.02.054
Tabašević I, Milanović D. Research of the scope of testing required for qualification of the hvac system. in Proceedings on Engineering Sciences. 2019;1(2):553-562. doi:10.24874/PES01.02.054 .
Tabašević, I., Milanović, Dragan, "Research of the scope of testing required for qualification of the hvac system" in Proceedings on Engineering Sciences, 1, no. 2 (2019):553-562, https://doi.org/10.24874/PES01.02.054 . .