The risk-oriented approach to the development and implementation of the pharmaceutical quality system in the production of in-bulk finished products

Baula, O. P.; Saliy, O. O.; Shevchenko, Olena; Shevchenko, T. O.

doi:10.24959/uekj.21.1

Manag. econ. qual. assur. pharm.

2021

DOI: 10.24959/uekj.21.1

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The risk-oriented approach to the development and implementation of the pharmaceutical quality system in the production of in-bulk finished products

O. P. Baula¹,

O. O. Saliy²,

Olena Shevchenko³

et al.

Abstract: Aim. To determine the areas of the risk-based approach to the development and implementation of the pharmaceutical quality system with the emphasis on the production of in-bulk finished products, identify the main factors affecting the stability of the functional characteristics of drugs in order to provide their compliance with the international quality standards, Good Manufacturing Practice and quality risk management. Results. 29 pharmaceutical companies with the license in Ukraine for dispensing and packin… Show more

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Cited by 3 publications

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Marketing research of the range of medicinal products based on salts of natural origin

Saliy

Baula

Мелеш

et al. 2022

Farm Zh

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As a source of supply of a balanced complex of salts in pharmaceutical practice, sea water (MW), sea salt (MS), obtained by the method of ordinary evaporation, or salt solutions made from standardized raw materials are used. Deep seawater (SW), typically pumped from depths greater than 200 m, contains a wealth of trace elements, including magnesium, calcium, potassium, chromium, selenium, zinc, and vanadium. Due to this, SW has the potential of a source and raw material for the creation of medicinal products for human health. The purpose of the work was to research the assortment of preparations based on salts of natural origin and analyze the segment of such products on the pharmaceutical market of Ukraine as of June 2022. The research was conducted on the basis of data from the State Register of Medicinal Products of Ukraine, the Morion information search program, and the classification system of the ATS electronic resource Compendium.online. Methods of structural, statistical and graphic analysis were applied in the work, and their generalization and systematization was carried out. It was established that on the pharmaceutical market of Ukraine, the segment of medicines, medical products and cosmetics, the source of active substances of which is SW and/or SS, is represented by 150 trade names. It was determined that by type of registration, the most common are medical products (51%) and cosmetics (42%), only 7% of registered drugs are registered. Manufacturers use sea water obtained from the deep water basins of the Adriatic, Aegean, Mediterranean Seas, Atlantic Ocean, Kankal Bay, sea water of Gullmarsfjorden. Domestically produced drugs of the investigated market segment occupy a share of 57%. Among the importing countries, the leaders are Croatia (9%) and Poland (5%). The analysis of the nomenclature established that the most common medicinal form of the drugs are nasal sprays (78%). The obtained data show that as the active substance of saline solutions, manufacturers declare SS (56% of the nomenclature) and SW (53%), however, not all products contain information about the source of origin of SS/SW. It was determined that there are no products on the pharmaceutical market of Ukraine based on the SW and SS of the Black and Azov seas, which is the basis for research and the creation of new drugs of domestic production.

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Marketing research of the range of medicinal products based on salts of natural origin

Saliy

Baula

Мелеш

et al. 2022

Farm Zh

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Research оn healthcare oxygen measures during the COVID-19 pandemic: latest trends and current priorities

Baula¹,

Saliy²,

Halstian³

et al. 2022

Farm Zh

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Medical oxygen is a critically needed medicine in the treatment of coronavirus disease. During out breaks of the COVID-19 pandemic, the needs of health care institutions for medical oxygen increase by 5-6 times. The issue of the reliable functioning of the oxygen supply system of health care institutions during the COVID-19 pandemic is extremely urgent and requires systematic research. The purpose of the work was to conduct research on measures to provide oxygen to health care facilities during the COVID-19 pandemic, to establish risk factors in its production and supply, and to determine priority directions for guaranteeing the ability to provide medical assistance in the treatment of coronavirus disease. The methods of systematic approach, bibliographic, information search, marketing analysis, as well as generalization and analysis were used during the research. The study showed that medical use of oxygen as a medicine, oxygen produced by medical devices, and technical oxygen was allowed at the state level. Domestic manufacturers produce medical oxygen that meets all regulatory requirements for medicinal products. In Ukraine, 36 drugs based on medical oxygen are registered, the production of which is carried out by 26 enterprises that have licenses for the production of medicinal products. During the pandemic, it was allowed for medical use of technical oxygen, which should meet the quality indicators of medical oxygen. The use of oxygen, which is produced by medical devices, which include oxygen generators and oxygen concentrators, which must meet the requirements of the Technical Regulations, became a significant measure for the expansion of oxygen therapy. During the implementation of all measures to provide oxygen, there are risks of a national and branch nature, as well as specific risks associated with the characteristics of different types of oxygen (oxygen as a medicine, oxygen produced by medical devices, technical oxygen). The identified list of risks and their analysis in the provision of oxygen to health care facilities during the COVID-19 pandemic will provide an opportunity to develop the concept of general risk assessment and risk management processes to guarantee the ability to provide adequate medical care in the treatment of coronavirus disease.

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Development of Approaches to Laboratory Control of «biotestlab» LTD to Ensure Quality of Veterinary Preparations

Saliy

Sinchuk

2021

SCIVP

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The article presents the development of approaches to laboratory control and the results of research related to the standardization of methods at Ltd "BIOTESTLAB" to ensure the quality of veterinary drugs. Attention is paid to the methods of biological quality control of veterinary drugs: microbiological purity, hemagglutination reaction (HAR), determination of infectious activity of embryonic vaccines. Because such methods are characterized by low automation, low accuracy, the impact on the result of error due to personnel performing operations manually, the lack of regulatory approaches to validation of methods. The influence on the reliability of the obtained results on determining the titer of infectious activity of the virus of the following factors: quality and concentration of the applied suspension of erythrocytes of a rooster, duration of cultivation of a virus, technique of performance by the controller of each operation of a technique is investigated. Studies on the influence of these factors were conducted on the example of determining the titer of infectious activity of Newcastle disease virus. Approaches to accounting for the obtained results by the method of qualitative HAR, namely visual control of hemagglutination reaction on glass and on a plate are established. A comparative characterization of the results for the detection of hem agglutinin of Newcastle disease virus on glass (using 2% suspension of erythrocytes) and on the plate (using 1% suspension of erythrocytes). The results of inter-laboratory comparative tests of microbiological methods conducted to verify the qualification and reliability of the results are presented. It is demonstrated that the proper organization of laboratory control in measures to confirm the results of control of quantitative methods and evaluation of biological material by standardizing methods, conducting internal laboratory testing and participation in inter-laboratory comparative tests ensures and guarantees the quality of veterinary drugs.

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The risk-oriented approach to the development and implementation of the pharmaceutical quality system in the production of in-bulk finished products

Cited by 3 publications

References 3 publications

Marketing research of the range of medicinal products based on salts of natural origin

Marketing research of the range of medicinal products based on salts of natural origin

Research оn healthcare oxygen measures during the COVID-19 pandemic: latest trends and current priorities

Development of Approaches to Laboratory Control of «biotestlab» LTD to Ensure Quality of Veterinary Preparations

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