Quality/risk management system in radiotherapy: Changes afoot

Author(s):  
N. Pourel ◽  
C. Meyrieux ◽  
A. Lisbona
2021 ◽  
Vol 8 (5) ◽  
pp. 362-376
Author(s):  
A. B. Kashirina ◽  
Zh. I. Aladysheva ◽  
N. V. Pyatigorskaya ◽  
V. V. Belyaev ◽  
V. V. Beregovykh

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.


Author(s):  
Renza Monteleone ◽  
Dieter Klarmann

AbstractQualification and validation are integral components of the quality risk management system. Decisions about the scope and extent of qualification and validation should be based on detailed and documented risk assessments performed by the key transplant program personnel (collection/processing/clinical) who are responsible for critical aspects of the relevant operations over the life cycle of the product or process.


2020 ◽  
Vol 22 (1) ◽  
pp. 59-63
Author(s):  
Ihor Nestoryshen ◽  
◽  
Ivan Berezhnyuk ◽  
Alina Brendak ◽  
◽  
...  

Introduction. The article emphasizes that the current features of the implementation of foreign economic activity require consideration of two factors that are contradictory to each other. In particular, on the one hand, the growth of external threats is forcing the governments of many countries to tighten control measures when crossing the state border of goods and commercial vehicles. On the other hand, according to international conventions and agreements (Kyoto Convention, WMO Framework Standards for Security, WTO Facilitation Agreement), measures to reduce the interference of regulatory authorities in the operational activities of economic operators are envisaged. In this context, the use of risk-oriented customs control tools, which allow simplifying business without reducing the level of national security, is becoming especially important. Purpose. The purpose of the article is to generalize and systematize foreign and domestic approaches to simplification of customs procedures through the use of risk-oriented instruments of customs control, as well as to develop their own proposals for simplification of foreign trade entities in the domestic regulatory field by using subject-oriented criteria. Results. The authors analyzed the provisions of the International Convention on the Simplification and Harmonization of Customs Procedures, the Framework Standards for Security and Facilitation of International Trade, the WTO Agreement on Trade Facilitation, which are provided for significant simplification of international trade procedures by reducing the share of customs inspections and controls. Сustoms security, customs clearance of goods and vehicles on the territory of the subjects of foreign economic activity or in another place permitted by the customs, without the direct participation of customs officials. These measures are based on the widespread use of risk-oriented instruments of customs control. It is noted that some of the provisions of international conventions and agreements on the use of risk-oriented instruments of customs control and simplification of economic operators have been implemented in domestic customs legislation, namely Art. 320 of the Customs Code of Ukraine introduced selective customs control, it is determined that the forms and scope of control sufficient to ensure compliance with legislation on state customs and international treaties of Ukraine in customs clearance are selected by customs (customs posts) based on the results of risk management. Conclusion. The study analyzes the peculiarities of the customs risk management system application in customs control in Ukraine, and offers proposals for the use of subject-oriented criteria of customs control as a simplification for honest economic operators to reduce the selectivity of risk profiles ASUR.


Sign in / Sign up

Export Citation Format

Share Document