Comparison of quality control methods for drugs against animal E. coliinfection in the State and European Pharmacopoeias

2020 ◽  
pp. 61-66
Author(s):  
Alsu Galiakbarova
Keyword(s):  
Quality Control ◽  
Russian Federation ◽  
The State ◽  
Farm Animals ◽  
E Coli ◽  
Pathogenic Escherichia Coli ◽  
Acute Infectious Disease ◽  
Document Collection ◽  
Standards And Regulations ◽  
The Russian Federation

E. coli infection is an acute infectious disease of all young farm animals which causes diarrhea. It is caused by pathogenic Escherichia coli and entails great damage to livestock. At the present stage there are about 30 remedies to prevent E. coli infection in animals circulating in the Russian Federation. Vaccine is an immunobiological that activates acquired immunity. Vaccination is one of the safest, most effective and affordable remedies for specific prophylaxis despite a great number of therapeutic (pharmacological) drugs. All immunobiologicals in Russia must be registered, certified and their circulation must be under control. Drugs must undergo rigorous quality control. The main regulatory document, collection of standards and regulations that determine the quality indicators of substances produced in the Russian Federation and drugs made from them is the State Pharmacopoeia. This article describes how to perform sterility test of various drugs that, in accordance with the regulations, must be sterile.

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.

The Destruction of Pharmaceutical Products as an Element of the Efficiency of State Control (Supervision) Over the Circulation of Medicines

2015 ◽  
Vol 70 (6) ◽  
pp. 741-747
Author(s):  
Fatima Nikolaevna Bidarova
Keyword(s):  
Quality Control ◽  
Russian Federation ◽  
Pharmaceutical Products ◽  
The State ◽  
The North ◽  
Control Functions ◽  
The Russian Federation ◽  
The Republic ◽  
State Quality ◽  
State Medical Academy

Background: The modern system of state quality control over medicine makes it possible to reveal and withdraw drugs, that do not meet the requirements. However the problem of the turnover of substandard and fake drug and their destruction in the Russian Federation is still urgent. The aim of the study: to evaluate the effectiveness of state quality control over medicine and the practice of fake medicine destruction. Methods: data of the official websites of the Ministry of Health of the Russian Federation and the Republic of North Ossetia — Alania, Russian Sanitary Inspection, National Center of Quality control and Certification of Drugs were included in the investigation. Method of unrepeated samples was used in sociological investigations. 225 questionnaires have been worked out. The research was carried out in the North-Ossetian State Medical academy during the period from 2013 to 2015 with the help of the National Center of Quality Control and Certification of Drugs. Results: The shortcomings of the state quality control over the rules of fake drug destruction were studied. It was found out that the mechanism of permanent data collection monitoring of revealing, moving and destruction of substandard and fake drug destruction has not been determined. The ineffectiveness of controlling measures under the condition of critical legal base deficiency has been confirmed. The analysis of terminology characterizing the order of fake drug destruction was carried out. Conclusion: deficiencies related to the implementation of the state quality control over the fake drug destruction rules revealed during the course of investigations prove the necessity of adopting measures in creating new model of control functions, increasing the results of activity.

scholarly journals Antrax in Primorsky Territory (1919–2020). Communication 1. Historical Records and Characteristics of Stationary Potentially Hazardous as Regards Antrax Areas

2021 ◽  
pp. 51-59
Author(s):  
Z. F. Dugarzhapova ◽  
M. A. Ivacheva ◽  
M. V. Chesnokova ◽  
E. V. Kravets ◽  
E. A. Reshetnyak ◽  
...  
Keyword(s):  
Russian Federation ◽  
Nutritional Value ◽  
The State ◽  
Farm Animals ◽  
Soil Toxicity ◽  
Historical Records ◽  
Reference Book ◽  
Urban Districts ◽  
The Russian Federation

The aim of the study was to analyze the state of stationary potentially hazardous areas as regards anthrax in the Primorsky Territory and update the Cadastre of stationary potentially hazardous as regards anthrax areas (SPHA) of the Russian Federation (2005).Materials and methods. The collection and survey of accounting and reporting documents, archival and informational materials, records on anthrax from veterinary institutions, Rospotrebnadzor, municipalities by the 72 registered anthrax SPHA of the Primorsky Territory have been carried out. The reference book of the Russian Soviet Federative Socialist Republic’s settlements endemic for anthrax (1976), the Cadastre of the stationary potentially hazardous as regards anthrax areas in the Russian Federation (2005) were used.Results and discussion. The description of anthrax cases in the Primorsky Territory goes back to 1894, the official registration of the disease – since 1919. The last cases of the disease in farm animals and population were noted in Kavalerovsky and Oktyabrsky districts in 1979. When updating the SPHA (2005), information on 82 dormant sites of the Territory in 22 municipal and six urban districts was clarified. In six districts of the Territory, anthrax was not officially registered. Most of the SPHAs are centered on the Khanka plain, where the network of transport routes, the largest number of livestock and population are concentrated. The data on the number of sick animals and people over a period of 1919–1929 have not survived, and in the period between 1980 and 2020 anthrax was not reported in the region. 173 animals and 34 humans were diagnosed with anthrax in 1929–1979 in Primorye. High epizootic activity was noted in the period of 1919–1941. In the Asian part of the Russian Federation, Primorsky Territory belongs to the regions under a mild epizootic and epidemiological disadvantage as regards anthrax. Monitoring of anthrax has shown that the persistence of the pathogen in the soils of ten districts of the Territory could be facilitated by the absence of soil toxicity (86,8 %) and an average nutritional value (23,5 %) in relation to the anthrax microbe.

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 Ways to Improve Quality Control of Culture Medium Used for Mycoplasma Detection

2019 ◽  
Vol 19 (3) ◽  
pp. 161-168
Author(s):  
S. M. Sukhanova ◽  
Z. E. Berdnikova ◽  
A. S. Tikhonova
Keyword(s):  
Quality Control ◽  
Russian Federation ◽  
Culture Medium ◽  
Culture Media ◽  
Growth Promotion ◽  
The State ◽  
Test Strain ◽  
Animal Blood ◽  
Mycoplasma Detection ◽  
The Russian Federation

An urgent safety concern associated with biological products is contamination with mycoplasmas, which may originate from donor tissues and organs, virus harvests, culture medium components, trypsin, animal blood serum, as well as be transmitted by personnel involved in the manufacture of medicines. Currently, due to an increase in the range of biologicals available, there is a need for more sensitive and specific test methods. In the Russian practice, microbiological (culture-based) testing of finished pharmaceutical products for mycoplasma contamination is performed using complex culture media whose sensitivity depends on the quality of proteins, ingredients, and reagents used. Growth promotion properties of the media are determined according to the State Pharmacopoeia of the Russian Federation, 14th ed., using a single test strain — Mycoplasma arginini G230 (M. arginini G230 industry reference material). The aim of the study was to analyse current Russian and foreign requirements for the quality control of culture media that are used for mycoplasma detection, in order to update and improve the quality control procedure in Russia. It was demonstrated that a compelling advantage of the State Pharmacopoeia of the Russian Federation is the possibility of using a semi-liquid culture medium which does not require special aerobic or anaerobic incubation conditions and allows for quantification of mycoplasma colonies and determination of mycoplasma titre in culture medium while testing its growth promotion properties using reference М. arginini G230 test strain. The analysis revealed some differences in Russian and foreign requirements for quality evaluation of culture media. These differences were taken into account when developing recommendations for improvement of the Russian test procedure, i.e. enlarging the range of test strains used and development of respective reference standards.

PROBLEMS OF SECULAR NATURE OF THE STATE PRINCIPLE IN THE RUSSIAN FEDERATION

2019 ◽  
Vol 12 (2) ◽  
pp. 21-24
Author(s):  
Gatsolaeva Aleftina Hadzibekirovna ◽  
◽  
Gabaraev Alan Shotaevich ◽  
Keyword(s):  
Russian Federation ◽  
The State ◽  
The Russian Federation

ALGORITHM FOR DETERMINING THE DEGREE VALUES OF CONFIDENTIAL DOCUMENTS OF THE ORGANIZATION

2017 ◽  
pp. 80-88
Author(s):  
Sergey Valerevich Belov ◽  
Irina Mikhalovna Kosmacheva ◽  
Irina Vyacheslavovna Sibikina
Keyword(s):  
Information Security ◽  
Russian Federation ◽  
Value Of Information ◽  
Weighting Factor ◽  
State Regulation ◽  
The State ◽  
Information Security Management ◽  
Pair Comparison ◽  
The Russian Federation ◽  
Properties Of Information

To solve the problem of information security management the method was proposed that allows determining the degree of importance of confidential documents of the organization. The urgency of the proposed algorithm was substantiated taking into account the requirements of the legislation of the Russian Federation in the sphere of information security. The stages prior to the formation of the list of confidential documents of the organization were described. A review of the main documents of the legal and regulatory framework was carried out including documents relating to the state regulation of relations in the sphere of information security. The classes of protected information for the accessing categories were considered. The criteria changes of the value of information in the process of time were represented. The algorithm of formation of the list of confidential documents of the organization based on the properties of information was offered. The algorithm is based on an expert method of pair comparison of alternatives. The result of the use of this method is a number of confidential documents, ranked in descending order of importance. For each document the weighting factor of importance can be calculated. The verification stage of the degree of expert consistency was included in the methodology to eliminate the use of erroneous expert data. The application of the methodology is illustrated by a calculated example.

Updating the methodology for providing incentive subsidies to depressed agricultural regions

2020 ◽  
Vol 19 (12) ◽  
pp. 2210-2224
Author(s):  
V.M. Sharapova ◽  
T.N. Medvedeva ◽  
E.A. Farvazova
Keyword(s):  
Russian Federation ◽  
Agricultural Sector ◽  
Methodological Approach ◽  
State Regulation ◽  
The State ◽  
State Support ◽  
Agricultural Producers ◽  
The Russian Federation ◽  
Depressed Regions ◽  
Agricultural Regions

Subject. The article considers a procedure for calculating and distributing State support to depressed agricultural regions in the framework of a new type of budget financing, i.e. compensating and stimulating subsidies. Objectives. The purpose is to evaluate the efficiency of the system of State regulation of agribusiness in a depressed region, determine the priority of modern methods of budgetary support from the State, improve the methodological approach to the distribution of State aid among subjects of the Russian Federation with low level of socio-economic development. Methods. The study draws on the abstract and logical method, methods of statistical analysis, grouping, comparison, and generalization. Results. We realized the objectives of the study, using the agricultural producers of the Kurgan Oblast case. The paper analyzes the condition of agricultural sector in the depressed region, assesses the State support system efficiency for the agricultural sector of the Trans-Ural region, considers government measures related to the regulation of the economy of backward regions. It presents an updated method of budget financing within an incentive subsidy by clarifying the calculations and introducing an additional indicator that reflects the level of remuneration of regional agricultural producers. Conclusions. The updated calculation methodology for incentive subsidies to depressed regions enables to build a certain economic rating of ten depressed regions of the Russian Federation, taking into account not only the volume of production and employment, but also the level of wages of agricultural workers.

The World Opened to Everyone. The Main Library of Krasnoyarsk Region has Celebrated 75-year Anniversary

2010 ◽  
pp. 99-100
Author(s):  
Julia N. Shubnikova
Keyword(s):  
Russian Federation ◽  
The State ◽  
Krasnoyarsk Region ◽  
The World ◽  
The Russian Federation ◽  
Krasnodar Region

On the State Universal Scientific Library of the Krasnodar region, which is one of the largest regional libraries in the Russian Federation.

Селекция и семеноводство картофеля в Камчатском крае

2018 ◽  
Author(s):  
N.I. Ryakhovskaya ◽  
T.P. Sherstyukova ◽  
M.L. Gamolina
Keyword(s):  
Russian Federation ◽  
Potato Yield ◽  
The State ◽  
Limiting Factors ◽  
State Register ◽  
Region Selection ◽  
New Varieties ◽  
The Russian Federation ◽  
Selection Of

Рассмотрены агроклиматические условия Камчатского края и лимитирующие факторы, сдерживающие рост урожайности картофеля. Приведены характеристики новых сортов картофеля селекции Камчатского НИИСХ созданных в соответствии с приоритетными для региона направлениями селекции, включенных в Государственный реестр селекционных достижений РФ и охраняемых патентами.Agroclimatic conditions of the Kamchatka Krai and limiting factors that restrain the growth of potato yield are considered. The characteristics of new varieties of potatoes of the selection of the Kamchatsky RIA are created in accordance with the priority for the region selection areas included in the State Register of Selection Achievements of the Russian Federation and protected by patents.

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