scholarly journals Comparison of the World Pharmacopoeias’ Requirements for the Quality of Cell Lines

2020 ◽  
Vol 20 (3) ◽  
pp. 159-173
Author(s):  
M. A. Vodyakova ◽  
A. R. Sayfutdinova ◽  
E. V. Melnikova ◽  
Yu. V. Olefir
Keyword(s):  
Quality Control ◽  
Cell Lines ◽  
Russian Federation ◽  
Human Cell ◽  
Quality Parameters ◽  
Test Methods ◽  
Regulatory Document ◽  
Biological Drugs ◽  
The Russian Federation

The cell line is one of the necessary components of a biomedical cell product (BMCP) which can include only viable human cells. In addition, human, animal, insect, or bacterial cell lines can be used as a substrate for the production of some biological drugs. The list of quality parameters and test methods for medicinal products quality control are specified in the State Pharmacopoeia of the Russian Federation, but it contains only a few general monographs on blood products and a few requirements for cell lines as substrates for the production of biological drugs (which cover all types of cells). Currently, there is no regulatory document comparable to the State Pharmacopoeia of the Russian Federation that would contain requirements and test methods for BMCP quality control in the Russian Federation. Thus, one of the issues that arises both during quality control and approval of BMCPs is the lack of a regulatory document defining requirements for BMCP quality parameters and test methods. However, some general monographs of the Russian Pharmacopoeia and other pharmacopoeias can be used for quality control of both cell lines and non-cellular components. The aim of the study was to analyse and compare different pharmacopoeial requirements for the quality of cell lines used as components in human cell- and tissue-based products (comparable to BMCPs), which could be used in BMCP quality control. The paper analyses general monographs of the United States Pharmacopoeia (USP), European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia, Pharmacopoeia of the Republic of Belarus, including general monographs on biological/biotechnological products, because their requirements apply to human cell lines included as components in products similar to BMCPs. The analysed approaches and methods of quality control of cell- and tissue-based products described in the USP and Ph. Eur. could form the basis for elaboration of general monographs for the Russian Pharmacopoeia, including identification, potency, viral safety, and mycoplasma tests that are based on the nucleic acid amplification technology and other tests for cell lines as components of BMCPs.

scholarly journals SCIENTIFIC AND TECHNICAL SOLUTIONS AND METHODS OF COMMUNICATION SERVICES QUALITY CONTROL

2021 ◽  
Vol 23 (4) ◽  
pp. 35-44
Author(s):  
M.A. Davliatova ◽  
Keyword(s):  
Quality Control ◽  
Russian Federation ◽  
Communication Channel ◽  
Services Quality ◽  
Technical Problem ◽  
Automated System ◽  
Communication Services ◽  
The Russian Federation ◽  
Technical Solutions

The paper is devoted to the analysis of known methods of communication servicesquality control, as well as presented innovative proposals developed by the author.: method of external quality control of services provided by the communication network (Patent for invention of the Russian Federation №2669535), aimed at solving a technical problem, which consists in presenting objective data on the quality of the provided services to consumers of communication services without their interference in the process of network functioning; billing method, taking into account the quality of the provided communication services (Patent for invention of the Russian Federation №2708512), aimed at expanding the functionality of billing systems and allowing to objectively determine the level of quality of the provided communication services for the subscriber; an automated system and method for accepting payments for high-quality communication services (Patent for invention of the Russian Federation №2705422), aimed at increasing the awareness of operators about the quality of communication services, accurate to the element of a composite communication channel.

scholarly journals Comparative Analysis of Russian and Foreign Pharmacopoeial Requirements for the Quality Control of Water for Injection: Challenges and Ways of Harmonisation

2019 ◽  
Vol 19 (2) ◽  
pp. 99-108
Author(s):  
S. M. Sukhanova ◽  
N. M. Minaeva
Keyword(s):  
Quality Control ◽  
Comparative Analysis ◽  
Russian Federation ◽  
Test Methods ◽  
The State ◽  
Sterile Water ◽  
Member States ◽  
Test Parameters ◽  
The Russian Federation ◽  
Pharmacopoeial Requirements

Parenteral dosage forms are dissolved using sterile water for injection whose quality is regulated by special requirements. The lack of a monograph on sterile water for injection in the State Pharmacopoeia of the Russian Federation, as well as the concept of harmonisation of pharmacopoeial standards adopted by the member states of the Eurasian Economic Union (EEU), which promotes the development of a unified system of product quality attributes, test methods and means of control, support the need for and importance of the elaboration of a special document. The aim of the work was to study the possibility of harmonisation of Russian and international pharmacopoeial requirements for the quality control of sterile water for injection used as a solvent for medicinal products. The article presents the results of a comparative analysis of requirements of the nine leading world pharmacopoeias and pharmacopoeias of the EEU member states for the quality control of sterile water for injection (lists of test parameters, norms, test methods). The Russian and foreign requirements for the quality control of sterile water for injection differ both in terms of test parameters and test methods used. The analysis of monographs showed that the quality of sterile water for injection is controlled using 12–18 parameters. The most significant differences in the pharmacopoeial requirements of the EEU member states affect nine quality attributes. The authors propose approaches that are harmonised with international requirements and involve the use of more accurate modern test procedures, optimisation of the list of test parameters and establishment of impurity limits for containers with different capacities in order to prepare a monograph on sterile water for injection for inclusion into the State Pharmacopoeia of the Russian Federation and the EEU Pharmacopoeia.

Implementation of an electronic system of monitoring of pregnant women as an effective way of the quality control of a medical care

2019 ◽  
Vol 2019 (3) ◽  
pp. 80-85
Author(s):  
Алла Самойлова ◽  
Alla Samoylova ◽  
Нина Рогинко ◽  
Nina Roginko ◽  
Софья Таубкина ◽  
...  
Keyword(s):  
Information System ◽  
Quality Control ◽  
Medical Care ◽  
Pregnant Women ◽  
Russian Federation ◽  
Electronic Monitoring ◽  
Electronic System ◽  
The Russian Federation

One of the effective ways of an improvement of the quality of a medical care for pregnant women is the electronic monitoring (distant monitoring) over state of pregnant women, women in labour, puerperas. The article presents the experience of use of the information system of pregnant women monitoring in several regions of the Russian Federation, analyses advantages and limitations of given systems, proposes the standardize system of a monitoring.

scholarly journals Culture Media in Pharmacopoeial Analysis: Use, Current Requirements, Standardisation

2019 ◽  
Vol 19 (3) ◽  
pp. 136-144
Author(s):  
S. M. Sukhanova ◽  
N. E. Zakharova
Keyword(s):  
Quality Control ◽  
Russian Federation ◽  
Culture Media ◽  
Storage Conditions ◽  
The State ◽  
National Standard ◽  
Medicinal Products ◽  
Suitability Assessment ◽  
The Russian Federation

Culture media with predetermined specific characteristics play a key role in ensuring safety, quality and efficacy of medicinal products, especially biologicals. It is necessary to formulate clear criteria for culture media suitability, because they are used not only in manufacture, but also in quality control of medicinal products. The expansion of the range of complex high-technology medicinal products containing biologically derived substances as active ingredients, whose quality and properties are tested by biological methods, calls for more stringent requirements for the quality of culture media. The aim of the study was to analyse requirements for the culture media used in the production of medicinal products — in order to identify approaches to the development of a national standard. Currently, culture media are not included into the State Register of Medicinal Products, and there are no standards that could be used by manufacturers to confirm that a culture medium complies with specific safety, efficacy and quality requirements. The paper summarises the results of the analysis of the State Pharmacopoeia of the Russian Federation, 14th ed., and nine leading world pharmacopeias’ requirements for culture media used for various purposes (manufacture, auxiliary purposes, and quality control). Most countries have adopted requirements mainly for those culture media that are used in purity tests. The analysis revealed differences both in the lists of requirements (test strains, incubation and storage conditions, preparation for use, suitability assessment), and the approaches to the establishment and presentation of requirements. The paper discusses the main challenges and risks associated with the quality control of culture media in accordance with the requirements of the State Pharmacopoeia of the Russian Federation, 14th ed. It outlines current national and international ways of improving the quality of culture media used in the production of medicinal products, and substantiates the need to develop an appropriate national standard. The paper suggests approaches to the development and standardisation of requirements for the quality of various types of media used in the production and control of medicines. These approaches could be used in the preparation of the general chapter Culture media.

scholarly journals Elaboration of Pharmacopoeial Quality Standards for Bacteriophage Products

2019 ◽  
Vol 19 (4) ◽  
pp. 233-241
Author(s):  
T. M. Kargina ◽  
E. I. Sakanyan ◽  
D. S. Davydov ◽  
R. L. Parfenyuk
Keyword(s):  
Russian Federation ◽  
Specific Activity ◽  
Quality Standards ◽  
Storage Conditions ◽  
Quality Parameters ◽  
Test Methods ◽  
Bacterial Strains ◽  
Test Procedures ◽  
Intestinal Infections ◽  
The Russian Federation

Bacteriophages are novel safe and efficacious medicinal products that are used for treatment of intestinal infections and purulent inflammations. The fact that virulent phages can be adapted to fight antibiotic-resistant bacterial strains makes this group of medicines a promising means of treatment of infections associated with medical interventions. The elaboration of quality standards for bacteriophage products will enable alignment of the quality requirements and test methods. There are no monographs on bacteriophage products in pharmacopoeias of other countries, therefore, the development of general chapters on groups of test methods used in bacteriophage quality control and monographs on bacteriophages for the State Pharmacopoeia of the Russian Federation (Ph. Rus.) was a very relevant and timely initiative. The aim of the study was to elaborate pharmacopoeial quality standards for bacteriophages approved in the Russian Federation for therapeutic and prophylactic indications. The authors of the study analysed product specification files and master production records for bacteriophages produced in the Russian Federation. They determined common GMP-compliant production steps, the selection criteria for bacteriophage strains and bacteria production strains, and cultivation and storage conditions. The authors standardised bacteriophage quality parameters and brought the test methods in line with the test procedures described in the Ph. Rus., 14th ed. The study summarised test methods used for identification of bacteriophages and determination of their specific activity. The main results of the study were included into the general monograph «Bacteriophages» and individual monographs on bacteriophage products that were included into the current edition of the Ph. Rus. Further studies and elaboration of new quality standards for mono- and multicomponent bacteriophage products, and the use of such products in clinical practice will improve prophylaxis and treatment of various infectious diseases.

scholarly journals International Practice of Storing Human Cell Lines Intended for Clinical Use

2018 ◽  
Vol 18 (4) ◽  
pp. 216-224
Author(s):  
O. A. Rachinskaya ◽  
A. A. Chaplenko ◽  
E. V. Melnikova ◽  
I. S. Semenova ◽  
Yu. V. Olefir
Keyword(s):  
Cell Lines ◽  
Russian Federation ◽  
Human Cell ◽  
Clinical Use ◽  
Human Cell Lines ◽  
Scientific Application ◽  
Cell Bank ◽  
Cell Material ◽  
The Russian Federation ◽  
Cell Banks

Currently, the Russian Federation does not have a well-established state-controlled market for cell banks (CB) containing cell material that is potentially applicable for clinical purposes. Cryopreservation of cells in cell bank (CB) is an important step in the production of a number of biomedical cell products and makes it possible to overcome difficulties faced by manufacturers during production and storage of large amounts of cell material. At present there are a large number of human cell lines in the world, which are stored in CB owned by commercial and public organisations in different countries. In addition, new cell lines are being banked every year. All this makes it difficult to find cell material suitable for production purposes or that could potentially be used as donor material in clinics. This study analysed the international practice of storing human cell lines for clinical use. The authors of the study systematised the existing CB worldwide and analysed regulatory documents governing the activities of these banks in different countries. The analysis revealed a trend towards formation of CB, often specialising in certain types of cells, as well as a trend towards creation of registries giving full information about cell lines including data on their scientific application. The increasing development and clinical use of cell therapy products in the Russian Federation and abroad will most likely lead to the increase in the number of CB and registry systems, as well as amounts of materials stored in them, including cell lines intended for clinical use.

scholarly journals Specifics of certification of agricultural tires with maximum consideration of their operating conditions

2020 ◽  
Vol 1 (4) ◽  
pp. 3-11
Author(s):  
S.V. Goncharenko ◽  
◽  
Z.A. Godzhaev ◽  
V.I. Pryadkin ◽  
A.V. Artyomov ◽  
...  
Keyword(s):  
Product Quality ◽  
Russian Federation ◽  
Test Methods ◽  
Operating Conditions ◽  
Modern World ◽  
Agricultural Vehicles ◽  
Legal Proceedings ◽  
National Market ◽  
The Russian Federation

The problems of product quality and competitiveness are typical in the modern world. The inter-national market constantly demands the improvement of the performance properties of automobiles, tractors, agricultural machinery and other types of mobile vehicles. At the same time, they can not be increased without significant improving of the tire performance characteristics. Pneumatic tires are among the critical units of mobile vehicles that have a significant impact on the following per-formance properties; therefore, as a complex product, they were included in the list of approval in accordance with Regulation No 106 for agricultural vehicles and their trailers. The purpose of the research was to develop recommendations for improving the methodology of conducting certifica-tion tests of agricultural tires aimed at improving product quality. The article discusses the methods of certification and approval of tires for agricultural vehicles and their trailers. The drawbacks of the method of certification of agricultural tires using the method of automobile ones are analyzed. It is proposed to supplement the certification with test methods developed in the Russian Federation that are as close as possible to the operating conditions of agricultural vehicles and tires of traction machines. The experience of work of “Bridgestone” and “Michelin” companies in the Russian Federation is presented. The absence of a national tire certification system in Russia influence in many cases vehicle breakdowns, which lead to downtime, as well as to the occurrence of accidents. In case of serious accidents in transport, when there is insufficient clarity of the causes of the accident or it is clear that the accident is related to tire failure, the victims initiate legal proceedings against the manufacturers, involving the payment of monetary compensation. At the same time, mass production defects are usually hidden behind the losses of consumers. To improve the quality of agricultural tires, it is proposed to revise UN/ECE Regulation No 106 as close as possible to operating conditions, as well as to create an independent accredited tire center.

Risks and economic security of the life support system of citizens in the field of housing and communal services

2020 ◽  
Vol 19 (3) ◽  
pp. 175-191
Author(s):  
Vladimir M. Yakovlev
Keyword(s):  
Quality Of Life ◽  
Russian Federation ◽  
Support System ◽  
Internal Control ◽  
Life Support ◽  
Economic Security ◽  
Security System ◽  
Life Support System ◽  
The Russian Federation

The article analyzes the problems of the manifestation of risks of shadow and criminal activity in the life support system of citizens of the Russian Federation, the dissemination of which requires the development of effective measures to prevent and eliminate them. The most important issue is the formation of an effective economic security system with an emphasis on the new quality of life support for citizens of the Russian Federation in an adequate combination with the high growth rate of NTP in the Russian economy. The new technological structure emerging from the new achievements of scientific and technological progress involves the harmonization of the pace of scientific and technological development, combined with an adequate improvement in the quality of life support for citizens performing such achievements. Owing to this fact formation of new quality of the housing and communal services (HCS) as bases of life support of citizens becomes a prerequisite of increase in performance and intellectualization of human work. With this in mind, early recognition, prevention and elimination of risks of shadow and criminal activities in the housing and communal services system (housing and communal services) is considered as a significant mechanism to increase the effectiveness of the system of comfortable life support for citizens of the Russian Federation. The existing lag in the development of a high-quality and comfortable system for providing citizens of Russia on the basis of housing and communal services, the subject of which is the provision of quality and comfortable services, influenced by numerous risks of shadow and criminal influence, becomes a condition for intensifying economic development and increasing labor productivity on this basis. The need to develop and use modern scientific and technical achievements, especially in the field of digitalization, is emphasized in order to increase the efficiency of the economic security system of housing and communal services organizations based on innovative control mechanisms - internal control, audit, compliance control, taking into account financial investigations in order to prevent and eliminate the risks of shadow and criminal activities in the housing and communal services system.

Assessing the quality of public health in the Russian Federation and Israel: Main problems and solutions

2020 ◽  
Vol 19 (4) ◽  
pp. 618-632
Author(s):  
A.S. Panchenko
Keyword(s):  
Public Health ◽  
Russian Federation ◽  
Population Based ◽  
The Public ◽  
Disability Adjusted Life ◽  
Problems And Solutions ◽  
The Russian Federation ◽  
Disability Adjusted Life Year ◽  
Practical Recommendations

Subject. The article addresses the public health in the Russian Federation and Israel. Objectives. The focus is on researching the state of public health in Russia and Israel, using the Global Burden of Disease (GBD) project methodology, identifying problem areas and searching for possible ways to improve the quality of health of the Russian population based on the experience of Israel. Methods. The study draws on the ideology of the GBD project, which is based on the Disability-Adjusted Life-Year (DALY) metric. Results. The paper reveals the main causes of DALY losses and important risk factors for cancer for Russia and Israel. The findings show that the total DALY losses for Russia exceed Israeli values. The same is true for cancer diseases. Conclusions. Activities in Israel aimed at improving the quality of public health, the effectiveness of which has been proven, can serve as practical recommendations for Russia. The method of analysis, using the ideology of the GBD project, can be used as a tool for quantitative and comparative assessment of the public health.

THE VALUE OF LOVE IN THE SYSTEM OF FORMATION OF THE PROFESSIONAL MATURITY OF THE EDUCATOR

2020 ◽  
Vol 1 (10(79)) ◽  
pp. 12-18
Author(s):  
G. Bubyreva
Keyword(s):  
Russian Federation ◽  
The State ◽  
Educational Process ◽  
Wide Range ◽  
The Family ◽  
The Russian Federation ◽  
The Government ◽  
The Individual ◽  
The Right

The existing legislation determines the education as "an integral and focused process of teaching and upbringing, which represents a socially important value and shall be implemented so as to meet the interests of the individual, the family, the society and the state". However, even in this part, the meaning of the notion ‘socially significant benefit is not specified and allows for a wide range of interpretation [2]. Yet the more inconcrete is the answer to the question – "who and how should determine the interests of the individual, the family and even the state?" The national doctrine of education in the Russian Federation, which determined the goals of teaching and upbringing, the ways to attain them by means of the state policy regulating the field of education, the target achievements of the development of the educational system for the period up to 2025, approved by the Decree of the Government of the Russian Federation of October 4, 2000 #751, was abrogated by the Decree of the Government of the Russian Federation of March 29, 2014 #245 [7]. The new doctrine has not been developed so far. The RAE Academician A.B. Khutorsky believes that the absence of the national doctrine of education presents a threat to national security and a violation of the right of citizens to quality education. Accordingly, the teacher has to solve the problem of achieving the harmony of interests of the individual, the family, the society and the government on their own, which, however, judging by the officially published results, is the task that exceeds the abilities of the participants of the educational process.  The particular concern about the results of the patriotic upbringing served as a basis for the legislative initiative of the RF President V. V. Putin, who introduced the project of an amendment to the Law of RF "About Education of the Russian Federation" to the State Duma in 2020, regarding the quality of patriotic upbringing [3]. Patriotism, considered by the President of RF V. V. Putin as the only possible idea to unite the nation is "THE FEELING OF LOVE OF THE MOTHERLAND" and the readiness for every sacrifice and heroic deed for the sake of the interests of your Motherland. However, the practicing educators experience shortfalls in efficient methodologies of patriotic upbringing, which should let them bring up citizens, loving their Motherland more than themselves. The article is dedicated to solution to this problem based on the Value-sense paradigm of upbringing educational dynasty of the Kurbatovs [15].

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