Assessment of the scope of testing required to qualification the BMS using FMEA methods
Samo za registrovane korisnike
2018
Konferencijski prilog (Objavljena verzija)
Metapodaci
Prikaz svih podataka o dokumentuApstrakt
In the pharmaceutical industry, BMS qualifications are carried out by applying structures models for risk management, in accordance to relevant GMP requirements. In this paper, the FMEA method of risk analysis for assessing the scope and qualification level of the BMS was applied. FMEA is a desirable method for risk management in the pharmaceutical industry because it involves improved reliability, superior quality, increased security and it is based on understanding the processes and on knowledge of the characteristics of the system itself. Through this paper potential problems are identified, the level of risk is assessed, and actions to reduce or completely eliminate risks from their impact on the BMS are proposed.
Ključne reči:
BMS, FMEA, qualification, pharmaceutical industryIzvor:
7th International Symposium of Industrial Engineering - SIE : Proceedings; 2018, 27th-28th September, 2018, Belgrade, 2018Izdavač:
- Belgrade: Faculty of Mechanical Engineering
Kolekcije
Institucija/grupa
Mašinski fakultetTY - CONF AU - Tabašević, Ilija AU - Milanović, Dragan AU - Misita, Mirjana PY - 2018 UR - https://machinery.mas.bg.ac.rs/handle/123456789/4115 AB - In the pharmaceutical industry, BMS qualifications are carried out by applying structures models for risk management, in accordance to relevant GMP requirements. In this paper, the FMEA method of risk analysis for assessing the scope and qualification level of the BMS was applied. FMEA is a desirable method for risk management in the pharmaceutical industry because it involves improved reliability, superior quality, increased security and it is based on understanding the processes and on knowledge of the characteristics of the system itself. Through this paper potential problems are identified, the level of risk is assessed, and actions to reduce or completely eliminate risks from their impact on the BMS are proposed. PB - Belgrade: Faculty of Mechanical Engineering C3 - 7th International Symposium of Industrial Engineering - SIE : Proceedings; 2018, 27th-28th September, 2018, Belgrade T1 - Assessment of the scope of testing required to qualification the BMS using FMEA methods UR - https://hdl.handle.net/21.15107/rcub_machinery_4115 ER -
@conference{ author = "Tabašević, Ilija and Milanović, Dragan and Misita, Mirjana", year = "2018", abstract = "In the pharmaceutical industry, BMS qualifications are carried out by applying structures models for risk management, in accordance to relevant GMP requirements. In this paper, the FMEA method of risk analysis for assessing the scope and qualification level of the BMS was applied. FMEA is a desirable method for risk management in the pharmaceutical industry because it involves improved reliability, superior quality, increased security and it is based on understanding the processes and on knowledge of the characteristics of the system itself. Through this paper potential problems are identified, the level of risk is assessed, and actions to reduce or completely eliminate risks from their impact on the BMS are proposed.", publisher = "Belgrade: Faculty of Mechanical Engineering", journal = "7th International Symposium of Industrial Engineering - SIE : Proceedings; 2018, 27th-28th September, 2018, Belgrade", title = "Assessment of the scope of testing required to qualification the BMS using FMEA methods", url = "https://hdl.handle.net/21.15107/rcub_machinery_4115" }
Tabašević, I., Milanović, D.,& Misita, M.. (2018). Assessment of the scope of testing required to qualification the BMS using FMEA methods. in 7th International Symposium of Industrial Engineering - SIE : Proceedings; 2018, 27th-28th September, 2018, Belgrade Belgrade: Faculty of Mechanical Engineering.. https://hdl.handle.net/21.15107/rcub_machinery_4115
Tabašević I, Milanović D, Misita M. Assessment of the scope of testing required to qualification the BMS using FMEA methods. in 7th International Symposium of Industrial Engineering - SIE : Proceedings; 2018, 27th-28th September, 2018, Belgrade. 2018;. https://hdl.handle.net/21.15107/rcub_machinery_4115 .
Tabašević, Ilija, Milanović, Dragan, Misita, Mirjana, "Assessment of the scope of testing required to qualification the BMS using FMEA methods" in 7th International Symposium of Industrial Engineering - SIE : Proceedings; 2018, 27th-28th September, 2018, Belgrade (2018), https://hdl.handle.net/21.15107/rcub_machinery_4115 .