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.

On the taxation of deposits and bonds and the need to qualify passive income

2021 ◽  
Vol 27 (4) ◽  
pp. 875-893
Author(s):  
Ol'ga S. BELOMYTTSEVA ◽  
Anna S. BALANDINA
Keyword(s):  
Comparative Analysis ◽  
Russian Federation ◽  
Income Tax ◽  
The State ◽  
Individual Investors ◽  
Personal Income Tax ◽  
Interest Income ◽  
State Classification ◽  
The Russian Federation

Subject. The article discusses the taxation of interest income from deposits and bonds in the Russian Federation from perspectives of individual investors and the State, classification of people’s income into active and passive. Objectives. We outline actions to adjust the fiscal policy on personal income tax to unify the taxation and stimulate the innovating activity of individuals. Methods. The study is based on methods of logic and comparative analysis. Results. Tactically, payers of interest income are now bound to inform taxpayers on accrued interest income, and the need to qualify coupons of government, municipal and corporate bonds for relief. The strategic result is determined as the need to qualify active and passive income. Conclusions and Relevance. The findings can be an agenda of the State Duma of the Russian Federation and promulgated in the Tax Code of the Russian Federation.

scholarly journals Significance of Legal Symbols in the Russian Federation

2019 ◽  
Author(s):  
Olga Viacheslavovna Kosatkina
Keyword(s):  
Comparative Analysis ◽  
Research Methods ◽  
Russian Federation ◽  
The State ◽  
The Russian Federation ◽  
The Law

The article considers the scope of legal symbolism in relation to the modern needs of society and the state. The research methods used in this article included general methods of cognition, as well as special methods used in the field of law, including interpretation of the law and comparative analysis. The obtained results can be used for informative, methodical and educational purposes.

scholarly journals BIOENERGETIC EFFICIENCY OF SEED PRODUCTION OF CORN HYBRIDS

2021 ◽  
Author(s):  
D.D. Babushkin ◽  
◽  
S.А. Zaytsev ◽  
◽  
Keyword(s):  
Comparative Analysis ◽  
Seed Production ◽  
Russian Federation ◽  
Crude Protein ◽  
The State ◽  
High Yield ◽  
Corn Hybrids ◽  
State Register ◽  
Gross Energy ◽  
The Russian Federation

We conducted the comparative analysis of bioenergetic efficiency of production of seeds of corn hybrids developed in breeding centers – participants of the Coordination Council on breeding and seed production of corn, included into the State register of breeding achievements permitted for production in the Russian Federation. We revealed corn hybrids with relatively high yield of gross energy: Neon 147 МV (71.4 GJ/ha), Katerina SV (68.4 GJ/ha), and crude protein: Neon 147 МV (0.45 t/ha), RNIISK-1 (0.43 t/ha), Baykal (0.44 t/ha).

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.

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.

The State Fund of Metrology of Russian Federation. Part 2. General-purpose, pulse and special dosimeters

ANRI ◽  
2020 ◽  
Vol 0 (4) ◽  
pp. 3-13
Author(s):  
Yury Martynyuk
Keyword(s):  
Comparative Analysis ◽  
Russian Federation ◽  
General Purpose ◽  
The State ◽  
Photon Radiation ◽  
Measuring Instruments ◽  
Pulse Radiation ◽  
State Information ◽  
The Russian Federation ◽  
State Fund

Lists of photon radiation dosimeters, as well as pulse radiation dosimeters and metrological dosimeters, included in the State Information Fund of Measuring Instruments of the Russian Federation are given. The results of a comparative analysis of the characteristics of these dosimeters groups are discussed.

scholarly journals Using banking statistics to assess the SME sector in the Russian Federation

2021 ◽  
Vol 227 (1) ◽  
pp. 161-181
Author(s):  
Anastasia O. Alekhnovich ◽  
◽  
Leonid L. Anuchin ◽  
Anton O. Akhiev ◽  
◽  
...  
Keyword(s):  
Comparative Analysis ◽  
Administrative Data ◽  
Russian Federation ◽  
Income Tax ◽  
Growth Index ◽  
The State ◽  
Personal Income ◽  
Personal Income Tax ◽  
Official Statistics ◽  
The Russian Federation

With the development of technologies for collecting, processing and storing data, many countries started to upgrade the systems of official statistics, complementing it with big and administrative data. One of the most detailed and operative sources of data on the economy is banking statistics. The article presents the results of a comparative analysis of the data of the SME Growth Index, formed on the basis of the data of Sberbank, and the data of the Federal Tax Service of the Russian Federation. The analysis showed that the data of banking statistics correspond to the data of the Federal Tax Service of Russia both in the distribution of observations in various sections (regions of the Russian Federation, size of the business), and make it possible to more quickly obtain data on the state of the sector, and can be used both for analyzing the SME sector and forecast parameters of its development. Based on the analysis of banking statistics for the 3rd quarter of 2020, the effect of “the sector whitewashing” and an increase in deductions on insurance premiums and personal income tax due to a decrease in the rate on insurance charges for SMEs from 30% to 15% was revealed. Further analysis based on data from the Federal Tax Service of Russia also confirmed this conclusion.

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.

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