scholarly journals The current state of the pharmaceutical market of Ukraine, quality assurance and falfication of medicines

Pharmacia ◽  
2021 ◽  
Vol 68 (2) ◽  
pp. 411-419
Author(s):  
Hanna Eiben ◽  
Liliia Hala ◽  
Valentyna Slipchuk
Keyword(s):  
Quality Assurance ◽  
Criminal Liability ◽  
Pharmaceutical Market ◽  
Quality And Safety ◽  
State Control ◽  
State Service ◽  
Drug Quality ◽  
Current State ◽  
Assurance System ◽  
Falsified Medicines

The aim of our article was the study of the current state of the pharmaceutical market of Ukraine in the context of the quality assurance of medicines and preventing the spread of falsified medicines (FM), the identification of the main problems in the field of circulation of medicines and the ways to solve them. It is established that the dynamic development of the pharmaceutical market and its high profitability cause problem of drug quality, increasing threats to the spread of FM in circulation and require the implementation of effective mechanisms for regulation of quality and safety of medicines. Analysis the annual official statistics of the State Service of Ukraine on Medicines and Drug Control for the period of 2008–2019 on the number of detected FM in circulation showed a steady trend of increasing FM and insufficient implementation of effective measures to combat them. The creation of effective quality assurance system of drugs and preventing the spread of FM need to improve the organization of state control of drug quality, strengthening criminal liability for falsification of drugs and optimization of the system of their detection.

scholarly journals Scientific approaches of a multi-level competitiveness assessment of quality assurance system for AIC products

2021 ◽  
Vol 59 (3) ◽  
pp. 263-276
Author(s):  
P. V. Rastorgouev
Keyword(s):  
Quality Assurance ◽  
Quality Management ◽  
Food Products ◽  
Quality Parameters ◽  
Regulation System ◽  
Quality Assurance System ◽  
Quality And Safety ◽  
Assurance System ◽  
Apc Regulation

High dependence of agri-food products competitiveness level on its qualitative parameters determines the need to orientate both the management of individual enterprises and the entire APC regulation system for formation of competitive advantages of domestic products in order to efficiently implement it in external and domestic markets. A prerequisite for reliably determine the direction of efficient solution to solve such a task is availability of a mechanism for objective assessment of the current product quality management system from the point of view of providing sustainable production of competitive product according to quality parameters. In connection with these objectives of the study were substantiation and development of practical oriented scientific approaches to assessment of competitiveness of the system for ensuring quality of agri-food products in modern conditions, taking into account the multi-levelness of the APC regulation system in the Republic of Belarus. As a result, system of principles of assessing competitiveness of system for ensuring quality of agri-food products has been developed. Targeted estimated criteria specifying the level of competitiveness of the system for ensuring quality differentially according to AIC regulation levels have been specified (republican, sectoral, individual business entities). Priority estimates of competitiveness of the quality assurance system for agri-food products have been developed, classified depending on the criteria of quality and safety assurance system, as well as the level of regulation of AIC and their area of application (national, regional and international markets). Implementation of proposals for assessing the competitiveness of the product quality assurance system at all levels of AIC management in practical activities will allow substantiating the most relevant areas for improving the existing quality management mechanisms, increase competitiveness of products in terms of quality parameters and strengthen the position of domestic manufacturers by increasing the confidence of potential and actual consumers in the supply system quality and safety of agri-food products.

Improvement of the quality assurance system for oil products to be transported by pipelines

2017 ◽  
Vol 7 (5) ◽  
pp. 88-96
Author(s):  
Sergey B. Khotnichuk ◽  
◽  
Vadim V. Bortnik ◽  
Fyodor V. Timofeev ◽  
Andrey A. Kuznetsov ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Oil Products ◽  
Quality Assurance System ◽  
Assurance System

scholarly journals Quality Assurance Systems in Nursing. A turning point in the world of nursing homes

2014 ◽  
Vol 5 (1) ◽  
pp. 99-108
Author(s):  
Pedro Andreo ◽  
Carmelo Gómez ◽  
Elena Carrasco ◽  
Inmaculada Martínez-Escámez ◽  
Inmaculada Alguazas ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Nursing Homes ◽  
Nursing Practice ◽  
Health Indicators ◽  
General Interest ◽  
Quality Assurance System ◽  
Nursing Service ◽  
Positive Effects ◽  
Assurance System ◽  
Positive Results

Developing and trying to achieve a high quality in the service nursing personnel provide at nursing homes by means of implementing quality assurance systems is a topic of general interest nowadays. These systems have already proved to be effective in other fields. That is why the focus of this study is to analyse the most relevant effects due to the implementation of a quality assurance method based on standard UNE EN ISO 9001:2008 in the nursing service of four nursing homes. An analysis of more than 200 answers of a satisfaction survey about the nursing service at four nursing homes has been carried out. A study on the available bibliography about the results obtained after having implemented a quality assurance system in the nursing service at nursing homes has also been carried out. Very positive results can be appreciated in the daily nursing practice at nursing homes as a consequence of using a quality assurance system. Clinical practice has improved considerably as a consequence. The study shows quality assurance systems to be a useful tool at the service of nursing practice at nursing homes. Positive effects resulting from the implementation of such quality assurance systems are evident as it can be seen from satisfaction surveys and health indicators.

scholarly journals [18F]F-PSMA-1007 Radiolabelling without an On-Site Cyclotron: A Quality Issue

2021 ◽  
Vol 14 (7) ◽  
pp. 599
Author(s):  
Valentina Di Iorio ◽  
Stefano Boschi ◽  
Anna Sarnelli ◽  
Cristina Cuni ◽  
David Bianchini ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Radiochemical Purity ◽  
Competent Authority ◽  
Radiochemical Yield ◽  
Synthesis Process ◽  
Control Parameters ◽  
Quality Issue ◽  
Assurance System ◽  
Quality Control Parameters ◽  
Specific Membrane

Radiopharmaceuticals targeting the prostate-specific membrane antigen (PSMA) has become the gold standard for PET imaging of prostate cancer. [68Ga]Ga-PSMA-11 has been the forerunner but a [18F]F-PSMA ligand has been developed because of the intrinsic advantages of Fluorine-18. Fluorine-18 labelled compounds are usually prepared in centers with an on-site cyclotron. Since our center has not an on-site cyclotron, we decided to verify the feasibility of producing the experimental 18F-labelled radiopharmaceutical [18F]F-PSMA-1007 with [18F]F- from different external suppliers. A quality agreement has been signed with two different suppliers, and a well-established and correctly implemented quality assurance protocol has been followed. The [18F]F- was produced with cyclotrons, on Nb target, but with different beam energy and current. Extensive validation of the [18F]F-PSMA-1007 synthesis process has been performed. The aim of this paper was the description of all the quality documentation which allowed the submission and approval of the Investigational Medicinal Product Dossier (IMPD) to the Competent Authority, addressing the quality problems due to different external suppliers. The result indicates that no significant differences have been found between the [18F]F- from the two suppliers in terms of radionuclidic and radiochemical purity and [18F]F- impacted neither the radiochemical yield of the labelling reaction nor the quality control parameters of the IMP [18F]F-PSMA-1007. These results prove how a correct quality assurance system can overcome some Regulatory Authorities issue that may represent an obstacle to the clinical use of F-18-labelled radiopharmaceuticals without an on-site cyclotron

scholarly journals Evaluating the quality and safety of health-related apps and e-tools: Adapting the Mobile App Rating Scale and developing a quality assurance protocol

2021 ◽  
pp. 100379
Author(s):  
Anna E. Roberts ◽  
Tracey A. Davenport ◽  
Toby Wong ◽  
Hyei-Won Moon ◽  
Ian B. Hickie ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Rating Scale ◽  
Mobile App ◽  
Quality And Safety ◽  
Health Related
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