scholarly journals Assessing the Correlation Between GMP Deviations and Potential Quality Defects of Medicinal Products: the Result of the Survey of Qualified Persons

2020 ◽  
Vol 9 (2) ◽  
pp. 151-158
Author(s):  
V. A. Orlov ◽  
V. N. Shestakov
Keyword(s):  
Russian Federation ◽  
Good Manufacturing Practice ◽  
Class I ◽  
Medicinal Products ◽  
Main Hypothesis ◽  
Risk Class ◽  
Regulatory Documents ◽  
The Russian Federation ◽  
Methodological Guidelines

Introduction. One of the key issues in the field of assessing the conformity of drug manufacturers with the requirements of good manufacturing practice (GMP) is a systematic methodology for classifying revealed deficiencies (deviations, non-conformities) by their level of criticality. Today the information included into regulatory documents regarding the definitions of critical, major and minor (other) deficiencies is not always sufficient for the use in GMP inspection practice, as well as in quality management systems of the pharmaceutical manufacturers. In terms to study approaches to the classification of GMP deviations applied in the practice of the Qualified persons of drug manufacturers in the Russian Federation, a survey was conducted in the form of a questionnaire. This work became a logical continuation of a previous study among employees of the pharmaceutical inspectorate of the Russian Federation.Aim. To identify the correlation between the classification of critical and major GMP deviations and potential class I and II quality defects of medicinal products.Materials and methods. The study was based on a survey of Qualified persons of drug manufacturers (56 respondents) using a questionnaire specially designed. The main hypothesis of the study is that specialists (Qualified persons) who make decisions on the classification of GMP deviations are guided by potential quality defects that may be caused by the indicated deviations. In the framework of the study, authors used the model of gradation of quality defects of the medicinal products into 3 classes (class I, II and III) according to the rate of their significance as indicated in the PIC/S and EMA guidelines. At the same time, for GMP deviations a three-level gradation system is also used: Critical, Major and Minor (Other). In designing of questionnaires for the survey, the focus was made on examples of quality defects of classes I and II and, accordingly, Critical and Major GMP deviations.Results and discussion. The results of the processing and analysis of questionnaires summarize the opinion of the majority of respondents about the direct relationship between product quality defects of the high risk (class I) and critical GMP deviations. Respondents also expressed the opinion that deviations that could trigger the occurrence of the class II quality defects in most cases will be classified as critical. The results obtained during the study also indicate the similarity of existing approaches of the classification of GMP deviations (deficiencies) between QPs of the drug manufacturers and pharmaceutical inspectors.Conclusion. The results of the study show that for the purpose of classifying (determining the criticality) of GMP deviations (deficiencies) , it is possible to use the rating system for the quality defects of medicinal products by the rate of their significance for the patient which is presented in EU regulatory documents and PIC/S guidelines. The results of the study also will facilitate the drawing of conclusions that today, not only from the position of regulatory authorities, but also for the pharmaceutical industry, there is a need to develop methodological guidelines with a focus on a risk-based classification of GMP deviations (deficiencies). These guidelines should take into account the potential impact of the mentioned GMPdeviations on the occurrence of the quality defects of medicinal products and, as a result, threats to the life and health of patients.

scholarly journals Comparison of Approaches to Stability Testing of Medicines in the Russian Federation and the Eurasian Economic Union

2021 ◽  
Vol 11 (1) ◽  
pp. 16-23
Author(s):  
A. I. Belanova ◽  
E. L. Kovaleva ◽  
L. I. Mit’kina
Keyword(s):  
Medicinal Product ◽  
Russian Federation ◽  
Marketing Authorisation ◽  
Storage Conditions ◽  
Stability Testing ◽  
Medicinal Products ◽  
Regulatory Documents ◽  
Eurasian Economic Union ◽  
The Russian Federation ◽  
Economic Union

Stability testing gives necessary data on the effect of such factors as temperature, light, humidity, etc. on the medicinal product quality. The results of these studies help to select suitable primary and secondary packaging and to determine storage conditions and shelf life for the product. The aim of this study was to compare current requirements for stability testing of medicinal products in the Russian Federation and the Eurasian Economic Union (EAEU). The study covered stability testing of small-molecule medicines. The paper describes evolution of approaches to stability testing in the Russian Federation. It summarises the main differences in basic requirements for stability testing as stipulated in the State Pharmacopoeia of the Russian Federation (Ph. Rus.) XIII edition, Ph. Rus. XIV edition, and EAEU regulations. The study demonstrated that the Russian Federation lacks regulations containing specific requirements for stability testing performed to support variations to marketing authorisation documentation. The Ph. Rus. XIV edition does not specify the extent of stability testing to be performed after switching to another manufacturer of the active ingredient or introduction into operation of a new manufacturing site where the medicinal product will be produced. At the same time, the EAEU regulatory documents contain requirements for stability testing for each type of the most frequent variations to marketing authorisation documentation. The study demonstrated the continuing relevance of bringing the Russian regulations on stability testing in line with those of the EAEU.

Value added tax in case of exports from the special economic zone in the Kaliningrad Oblast

2021 ◽  
Vol 17 (8) ◽  
pp. 1433-1448
Author(s):  
Elena Yu. SIDOROVA ◽  
Aleksei A. ARTEM'EV
Keyword(s):  
Russian Federation ◽  
Value Added ◽  
Special Economic Zone ◽  
Federal Law ◽  
Value Added Tax ◽  
Free Economic Zone ◽  
Kaliningrad Oblast ◽  
The Russian Federation ◽  
Economic Zone ◽  
Methodological Guidelines

Subject. The article focuses on the value added tax in case of exports from the special economic zone in the Kaliningrad Oblast. Objectives. We study methodological aspects of VAT in case of exports from the special economic zone in the Kaliningrad Oblast. Methods. We conducted the content analysis of available sources. The comparative analysis helped confirm the reasonableness, reliability and the relevance of methodological guidelines for determining economically adequate tax implications in terms of VAT in case of exports from the special economic zone in the Kaliningrad Oblast. Results. Importing foreign goods into the special economic zone of the Kaliningrad region and letting them pass the customs procedure of free economic zones, a Kaliningrad-registered legal entity was found to exempt from customs payments, including VAT as part of customs payments under the above procedure. Being transported to elsewhere in the EAEU, any goods in the free economic zone should be treated as foreign goods, unless their status as the EAEU goods is corroborated with documents. The effective tax and customs regulations provide for VAT to be paid on imports into the Russian Federation, including as part of customs payments, and subsequently VAT on the sale of goods in the Russian Federation. VAT on imports, inter alia, as part of customs payments is subject to tax deductions as per Articles 171, 172 of the Russian Tax Code. Conclusions and Relevance. The taxation mechanism herein is identical to that applying to exports from the free economic zone to elsewhere in the customs area of the EAEU if there were not tax clauses envisaged in Federal Law № 72-ФЗ. Hence, the above clauses seem reasonable to be excluded.

Objectives of the penal system and problems of differentiation of convicted persons to deprivation of liberty

2020 ◽  
pp. 63-72
Author(s):  
Сергей Михайлович Савушкин
Keyword(s):  
Program Development ◽  
Russian Federation ◽  
Penal System ◽  
Correctional Institutions ◽  
Existing Problems ◽  
Nelson Mandela ◽  
Target Program ◽  
The Russian Federation ◽  
Development Concept

Важность определения конкретных, измеримых и объективно необходимых целей деятельности исправительных учреждений уголовно-исполнительной системы объясняется проблемами, с которыми сталкиваются сотрудники при выполнении функций, отдельные из которых не способствуют достижению целей уголовно-исполнительного законодательства РФ. В статье рассматриваются и подвергаются конструктивной критике цели уголовно-исполнительного законодательства, задачи уголовно-исполнительной системы (которые в 2004 г. были исключены из закона), основные задачи ФСИН России, основные цели Концепции развития уголовно-исполнительной системы РФ до 2020 г., цель Концепции федеральной целевой программы «Развитие уголовно-исполнительной системы (2017-2025 годы)». Приводятся цели классификации осужденных, которые предусмотрены Правилами Нельсона Манделы, как положительный опыт закрепления целей отдельного правового института. Высказывается позиция относительно необходимости закрепления целей отдельных институтов, промежуточных целей и важности определения точных критериев оценки достижимости отмеченных целей. Данная работа проводится для выявления имеющихся проблем, связанных с отсутствием конкретных показателей деятельности исправительных учреждений, выполнение которых должно способствовать достижению целей уголовно-исполнительного законодательства РФ. The importance of determining the specific, measurable and objectively necessary goals of the activities of correctional institutions of the penal system is explained by the problems faced by employees in performing functions, some of which do not contribute to the achievement of the goals of the penal legislation of the Russian Federation. The article discusses and criticizes constructively the goals of the penal legislation, the tasks of the penal system (which were excluded from the Law in 2004), the main tasks of the Federal Penitentiary Service of Russia, the main goals of the Development Concept of the Russian penal system until 2020, the goal of the Federal Concept target program "Development of the penal system (2017-2025)". The goals of the classification of convicts, which are provided for by the rules of Nelson Mandela, as a positive experience in fixing goals, a separate legal institution. A position is expressed regarding the need to consolidate the goals of individual institutions, intermediate goals and the importance of determining, exact criteria, assessing the attainability of the stated goals. This work is carried out in order to establish the existing problems associated with the lack of specific indicators of the activity of correctional institutions, the implementation of which should help achieve the goals of the criminal-executive legislation of the Russian Federation.

Legal and clinical aspects of emergency burns

2020 ◽  
Vol 22 (4) ◽  
pp. 208-211
Author(s):  
V. A. Sokolov ◽  
I. F. Shpakov ◽  
Ya. L. Butrin
Keyword(s):  
Russian Federation ◽  
Clinical Aspects ◽  
Practical Skills ◽  
Federal Law ◽  
Emergency Rescue ◽  
Medical Evacuation ◽  
Emergency Situations ◽  
The Russian Federation ◽  
Key Questions

The key questions concerning particular sections of the topic Burns in Emergencies are presented. Particular attention is paid to the presentation of terminology. For this, the wording of the Federal Laws, Government Resolutions and Orders of the Ministry of Health of the Russian Federation were used. In accordance with the latter, the classification of emergency situations is given, as well as the criteria by which their damage is assessed. It has been established that the involvement of the forces and means of the Ministry of Defense in the elimination of the consequences of emergency situations is spelled out in the Federal Law. In addition, an argument is made on what basis the citizens of the Russian Federation are obliged to constantly improve their knowledge and practical skills in studying numerous issues of protecting the population, providing assistance to victims, in carrying out emergency rescue operations, etc. situations that led to massive burns. Key features of burns as injuries sustained in emergency situations are formulated. Also, aggravating circumstances are listed that negatively affect the general condition of the victims. The role and place of clinical guidelines as a fundamental development governing the sequence of the organization and content of medical care for those burned at the stages of medical evacuation are indicated. Attention is drawn to the legal significance of the problem.

scholarly journals Constitutional-Legal and Administrative-Legal Bases of the Status of Migrants

2020 ◽  
Vol 6 (2) ◽  
pp. 263-267
Author(s):  
S. Popova ◽  
Yu. Chernov
Keyword(s):  
Russian Federation ◽  
Social Order ◽  
Theoretical Aspect ◽  
Legal Basis ◽  
The Rule Of Law ◽  
Current State ◽  
The Status ◽  
Internal Migrants ◽  
The Russian Federation

The study of the constitutional and legal basis of the status of migrants will allow to determine and summarize the rights and obligations of these persons, which significantly affect the formation of legal social order. This article discusses the constitutional, legal and administrative basis of the status of migrants, regulated by the legislation of the Russian Federation. Considering the issue of the current state of the migration legislation of the Russian Federation, the theoretical aspect of migration as the mobilization of people to change their permanent residence is highlighted. The causes of this phenomenon and the classification of categories of migrants are determined. The definitions of external and internal migrants are differentiated, on the basis of which the constitutional norms of foreign persons who entered the territory of the Russian Federation are further studied. According to Federal laws, the basic rights and obligations of immigrants who entered the Russian Federation for different definitions of reasons and circumstances are distinguished. The article considers the administrative and legal basis of the status of migrants in the context of violation of the rule of law according to the norms of the Code of administrative violations. The Institute of citizenship is singled out as a status that directly affects the scope of individual rights and freedoms, which allows it to be singled out as a special status of a migrant. In conclusion, the above topic is summarized.

scholarly journals Methods of big data definition: Russian and foreign experience

2021 ◽  
pp. 143-157
Author(s):  
Kseniia Antipova
Keyword(s):  
Big Data ◽  
Russian Federation ◽  
Personal Data ◽  
Legal Regulation ◽  
The European Union ◽  
Legal Doctrine ◽  
Original Definition ◽  
Data Definition ◽  
The Russian Federation

This article explores the main approaches of Russian and foreign authors towards big data definition; reflects the classification of data, components of big data; and provides comparative characteristics to legal regulation of big data. The subject of this research is the legislation of the Russian Federation and legislation of the European Union that regulate the activity on collection, processing and use of big data, personal data and information; judicial and arbitration practice of the Russian Federation in the sphere of personal data; normative legal acts of the Russian Federation; governmental regulation of the Russian Federation and foreign countries in the area of processing, use and transmission of data; as well as legal doctrine in the field of research dedicated to the nature of big data. The relevance of this research is substantiated by the fact that there is yet no conceptual uniformity with regards to big data in the world; the essence and methods of regulating big data are not fully explored. The goal of this research is determine the legal qualification of the data that comprise big data. The task lies in giving definition to the term “big data”; demonstrate the approaches towards determination of legal nature of big data; conduct  classification of big data; outline the criteria for distinguishing data that comprise the concept of big data; formulate the model for optimal regulation of relations in the process of activity on collection, processing, and use of the data. The original definition of big data in the narrow and broad sense is provided. As a result, the author distinguishes the types of data, reflects the legal qualification of data depending on the category of data contained therein: industrial data, user data, and personal data. Attention is also turned to the contractual form of big data circulation.

scholarly journals Approaches and methods for calculating the initial (maximum) price of contracts for the supply of goods, performance of work, provision of services for state and municipal needs

2021 ◽  
pp. 302-318
Author(s):  
М.Г. Городничев ◽  
Л.В. Егорова ◽  
А.М. Измайлов ◽  
А.Ю. Казанская ◽  
Е.А. Кандрашина ◽  
...  
Keyword(s):  
Russian Federation ◽  
Practical Significance ◽  
Relevant Issue ◽  
Maximum Price ◽  
Provision Of Services ◽  
The Russian Federation

В соответствии с законодательством Российской Федерации заказчики для осуществления закупки необходимо обосновать объект закупки, необходимость его закупки, план-график осуществления закупки, начальную (максимальную) цену контракта, а так же способ ее определения, что является актуальным вопросом, в контексте которого в статье изложены подходы и методы для обоснования (расчета) начальной (максимальной) цены контрактов на выполнение работ, оказание услуг и поставок товара, реализуемых в рамках федеральных и национальных проектов, государственных и целевых программ в сфере образования и науки. Практическая значимость материалов статьи заключается в том, что в них представлены классификация существующих подходов и методов, а также рекомендации по их применению для определения цены контракта в зависимости от предмета контракта. In accordance with the legislation of the Russian Federation, customers need to justify the object of purchase, the need for its purchase, the procurement schedule, the initial The (maximum) price of the contract, as well as the method of determining it, which is a relevant issue in the context of which the article sets out the approaches and methods to justify (calculating) the initial (maximum) price of contracts for the performance of work, the provision of services and supplies of goods implemented within the framework of federal and national projects, state and target programs in the field of education and science. The practical significance of the article is that it presents a classification of existing approaches and methods, as well as recommendations on their use to determine the price of a contract depending on the object of the contract.

scholarly journals MINI-PARLIAMENTS IN THE POST-DICTATORSHIP DEMOCRACIES OF WESTERN EUROPE AND LATIN AMERICA

2020 ◽  
Vol 24 (4) ◽  
pp. 942-964
Author(s):  
Alexey S. Koshel
Keyword(s):  
Latin America ◽  
Russian Federation ◽  
Western Europe ◽  
Parliamentary Democracy ◽  
Present Stage ◽  
The Russian Federation ◽  
Ongoing Development ◽  
Parliamentary Procedure

The article investigtes the powers and parliamentary procedures in the standing committees and commissions of several countries of Western Europe and Latin America. The author believes that one of the modern paradigms for the development of parliamentary democracy is to strengthen the role of standing committees in the work of parliament by transferring to the committee level a number of constitutional powers of parliaments. In this regard, the author clarifies approaches to the classification of the committee structure of parliaments and looks at committee parliamentary procedures in Italy, Germany, Greece, Portugal, Spain, Brazil and Argentina at the present stage. The author comes to certain conclusions regarding the paradigm of the committee parliamentary procedure, including further improvement of domestic constitutional-legal matter in the context of the ongoing development of parliamentary democracy in the Russian Federation.

scholarly journals Spatial outlines of an innovative system, capable of innovative reproducing

2021 ◽  
pp. 69-76
Author(s):  
Maksim A. Asaul ◽  
◽  
Nikita S. Zaitsev ◽  
Keyword(s):  
Russian Federation ◽  
Innovation System ◽  
Innovation Process ◽  
Innovation Systems ◽  
Innovative Products ◽  
Innovative System ◽  
The Russian Federation

It is established to what extent an innovative system, limited by the framework of a region - a subject of the Russian Federation, is capable of expanded reproduction. The spatial contours of the local innovation system are justified by the boundaries of the macroregion. The classification of domestic innovation systems on a spatial basis is carried out. The problems that do not contribute to the implementation of the entire chain of the innovation process in the local innovation system are formulated: from the generation of knowledge to the production of finished innovative products.

Evolution of Hotel Classification System in Russian Federation

2021 ◽  
Vol 12 (1) ◽  
pp. 277
Author(s):  
Dmitry Aleksandrovich KOZLOV
Keyword(s):  
Russian Federation ◽  
Classification System ◽  
State Standards ◽  
Classification Systems ◽  
International Standards ◽  
Economic Activities ◽  
World Tourism Organization ◽  
The Russian Federation ◽  
Tourism Organization

The main aim of this paper is to analyze the approaches to the system of classification of accommodation facilities in the Russian Federation. The United Nations World Tourism Organization pays great attention to the unification of classification systems for accommodation facilities in all countries of the world, issuing appropriate recommendations on tourism statistics systems, classification of economic activities, as well as criteria for interregional harmonization. In the Russian Federation, there are a number of laws, regulations, state standards, building and sanitary norms and rules concerning the classification of accommodation facilities. They are so imperfect that they have to be revised almost annually or even several times a year. The general statistics of accommodation facilities currently do not correspond to world recommendations. The classification system needs to be revised and brought into line with international standards as much as possible.

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