Quality Risk Assessment Production of Beta Lactams by FMEA Model and Fuzzy Theory Method

Hajimolaali, Mohamad; Asl, Akbar Abdollahi

doi:10.4172/2327-5146.1000222

Cited by 3 publications

(2 citation statements)

References 5 publications

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“…Предприятия имеют широкий ассортимент выпускаемой продукции, лекарственные средства производят в разных условиях -от нестерильных до асептических, процессы производства имеют различные стадии и способы контроля. Каждому предприятию необходимо сделать свой индивиду-альный выбор методов оценки рисков, способов информирования о рисках, разработать документацию и т.д., учитывая особенности своего производства и системы качества [12][13][14][15][16]. Проведенный поиск и анализ литературы показал, что в национальных и международных регламентирующих документах содержатся только принципиальные подходы к управлению рисками для качества, при этом разъясняющие методические материалы, содержащие конкретные примеры возможных подходов к управлению рисками для качества, в том числе для специфических производств, отсутствуют.…”

Section: оригинальная статьяunclassified

Analysis of Industrial Practice of Drug Quality Risk Management in Russian Pharmaceutical Enterprises

Каширина

Аладышева

Pyatigorskaya

et al. 2021

Farm. farmakol. (Pâtigorsk)

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The aim of the research was to study the current industrial practice of drug quality risk management in Russian pharmaceutical enterprises, including the assessment of the main problems during the implementation of the risk management system and its compliance with the accepted international approaches.Materials and methods. In the period from 6 April to 10 May 2020, an online survey of the leading employees in the field of quality assurance of Russian manufacturers was conducted. In the survey, the questionnaire was based on the results of the authors’ analysis of the national regulatory legal acts of the Russian Federation, the European Union countries, international guidelines of the EAEU, ICH and WHO in this area. 111 people took part in the survey, the return of questionnaires was 11.5%.Results. The data obtained indicate the prevalence of a superficial approach to quality risk management in the Russian pharmaceutical industry, the presence of objective and subjective reasons that hinder the effective implementation of these methods, the fragmentation of the systems used and, in most cases, their ineffective use. The respondents believe that the most significant reasons for the difficulties in implementing this methodology, are the lack of recommendations from the Ministry of Industry and Trade of Russia on creating an effective quality risk management system and a shortage of the specialists who are ready to work in the area of this industry. The survey revealed rather large gaps in the deployment of a risk management system at the enterprise and separation from the established international practice.Conclusions. The data obtained indicate the extreme urgency of developing recommendations for a quality risk management system, which should be based upon and supported by Russian regulatory legal acts and international experience in this area. The authors propose highlights for these recommendations.

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Section: оригинальная статьяunclassified

Analysis of Industrial Practice of Drug Quality Risk Management in Russian Pharmaceutical Enterprises

Каширина

Аладышева

Pyatigorskaya

et al. 2021

Farm. farmakol. (Pâtigorsk)

View full text Add to dashboard Cite

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“…In spite of all these papers there are few papers about FMEA and pharmaceutical industry such as Lv and Liang (2014), Bhattacharya (2015) and Hajimolaali and Asl (2016) [11][12][13]. These papers are very valuable studies about FMEA and risk management in pharmaceutical industry.…”

Section: Introductionmentioning

confidence: 99%

An integrated approach by fmea & fuzzy prioritization method at pharmaceutical ındustry quality control

Yücenur

Çataltepe²,

Sakin³

2020

Cumhuriyet Science Journal

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Protecting public health, taking preventive measures and ensuring recovery in case of any disease are conditions for creating a healthy life. In order to create this life, the manufacturing process of the pharmaceutical industry needs to be formed carefully. In this study there is a risk analysis application into operational processes of a pharmaceutical company. In application study, operational processes of sample company were examined and analyzed from October to May. Within the scope of the study, a two-stage approach was proposed in the analysis of the data obtained. In the first phase, fishbone analysis was carried out to determine the risks in the operational processes and the potential risks in two separate production lines were determined. In the second stage, the risk prioritization method was used and risk priority numbers (RPN) were calculated for all risks. In all these analysis, more realistic and valid results were obtained with the usage of fuzzy logic and the calculations of RPNs were made more objective and independent from analysts. After the determination of RPNs, precautions were suggested for high risky failures. Following the implementation of precautions, new RPNs were calculated for all failures. The old and the new RPNs were compared for all risky failures and all precautions were examined with their impacts on the process. As a result, all examined failures' risk prioritization numbers were reduced in the ratio between 72% and 90%, the operational processes were improved.

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Risk Assessment of Oil Reservoirs of Amout-E-Arvand Free Zone Area at the Explotiation Phase Using FMEA Method

Hamidan¹,

Dashti²

2018

j.health

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Background & objectives: With increasing development of knowledge and the emergence of new technologies in industry especially in the oil industry and the creation of highly complex systems, the implementation of the principles of safety, health and environmental management has been of particular importance in preventing accidents. This study was conducted to assess risk of oil resevoirs in Amout-E-Arvand Free Zone. Methods: In this study, FMEA method was used to identify and determine the significance of health, safety and environmental risks. Results: Based on the results obtained in the process of exploitation of Amout-E-Arvand oil reservoirs, of 14 identified risks, four of them are at critical level, of which 3 risks have been occurred due to human error. These three risks are leakage from LPG reservoirs, explosion and fires (caused by LPG tanks), vehicles and vehicle accident. The occurrence of natural disasters, with the value of RPN (240), has the highest risk. Conclusion: The use of the FMEA method can also identify and prioritize activities and risk indicators, plan to prevent and eliminate significant risks.

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Quality Risk Assessment Production of Beta Lactams by FMEA Model and Fuzzy Theory Method

Cited by 3 publications

References 5 publications

Analysis of Industrial Practice of Drug Quality Risk Management in Russian Pharmaceutical Enterprises

Analysis of Industrial Practice of Drug Quality Risk Management in Russian Pharmaceutical Enterprises

An integrated approach by fmea & fuzzy prioritization method at pharmaceutical ındustry quality control

Risk Assessment of Oil Reservoirs of Amout-E-Arvand Free Zone Area at the Explotiation Phase Using FMEA Method

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