scholarly journals Quality management of the chemical-technological process for continuous synthesis of pharmaceutical substances of medicinal compounds in flow microreactors

Author(s):  
V. F. Kornyushko ◽  
O. M. Nikolaeva ◽  
A. V. Panov ◽  
R. R. Biglov ◽  
A. S. Kuznetsov

Objectives. The introduction of digital tools for the development of medicines, intelligent management systems, and quality control is stipulated not only by modern requirements for the chemical and pharmaceutical industry but also by strict regulatory requirements for manufactured products. This principle ensures the release of a quality product on the first attempt. The aim of this study is to develop information support for the intelligent quality management system for the production of active pharmaceutical substances (APSs) for medicines using a fundamentally new technology: continuous synthesis in flow microreactors. To develop the necessary information support, we developed appropriate systemic, informational, and mathematical models; algorithms for the online management of the experiment; and techniques and algorithms to qualitatively assess whether the product meets official regulatory documents.Methods. System analysis techniques, information and mathematical modeling techniques with multireference regression models, and online optimization using the Hook–Jeevs algorithm (a method of expert evaluation based on the concordance factor) were used to solve the problems formulated.Results. To manage the quality of the process of continuous APS synthesis in the flow microreactor, we developed theoretic multiple system models that were designed to build the digital information environment for the process of experimental research. We developed algorithms for mathematical modeling and optimization of the control process based on multiresponse regression models and an online optimization algorithm that allows the process to be managed step by step, taking into account the limitations. Our results show that the degree of conversion is higher in reactions that contain bromodiphenylmethan.Conclusions. Based on mathematical modeling method algorithms for the quality control of the process of continuous APS synthesis on a fundamentally new microreactor system, Qmix were developed. The applicability of the proposed methods and algorithms in the production of the drug diphenhydramine from chlorobenzohydrol and bromobenzohydrol as initial substances was proven by an experimental study. The built models were statistically adequate and valid.

2020 ◽  
Vol 13 (2) ◽  
pp. 206-217
Author(s):  
V. P. Soloviev ◽  
T. A. Pereskokova

The authors of the article explore the problem of introducing process and risk-oriented thinking in national organizations. In 2000 the International Organization for Standartization, ISO, announced process approach as the basis principle of management in any organization. It became the embodiment of Deming’s postulate who recommended to consider any activity as a technological process. The authors show the practicability of transition from the functional structure of an organization to integrated process. New ISO 9000:2015 standards reflect presentday challenges and require that organizations should carry out risk assessment and accounting. One of the key objectives of the quality management system is to act as the prevention tool. Preventive action lies in using riskoriented thinking in formulating requirements to the quality management system. The authors introduce the system analysis method in risk management to reveal potential risks and plan preventive action.


2020 ◽  
Vol 3 (1) ◽  
pp. 48
Author(s):  
Li Zhang

With the continuous development of China’s medical industry in recent years, relevant staff has also paid more attention to the quality management of blood stations, and China has gradually improved during the setting of laws and regulations for blood station quality management. The policies set by the Chinese government have been fully implemented through the reasonable implementation of relevant staff. With the continuous development of China’s medical industry in recent years, relevant staff have also paid more attention to the quality management of blood stations, and China has gradually improved during the setting of laws and regulations for blood station quality management. The policies set by the Chinese government have been fully implemented through the reasonable implementation of relevant staff. On this basis, the management model of the Chinese blood station has been continuously innovated in the application process, and the blood collection work of the Chinese blood station has been greatly developed. However, when the blood station in China is conducting blood collection, its quality control program is still not fully mature. Therefore, in this context, it is necessary to do a good job in the construction of the corresponding blood station quality management system and make effective adjustments, which will give full play to the role of the management system in the quality control process of blood collection. In this paper, the construction plan of the blood station quality management system is analyzed to explore the role of the blood station quality management system in the process of blood collection quality control, aiming to provide assistance for the quality management of blood collection in China.


2021 ◽  
Author(s):  
Jin Wang ◽  
Xianghua Ma

BACKGROUND From the perspective of medical ethics, patient safety is the core before any other factors within health science. As the application of health science, medical services are inseparable from the safety of patients' lives and medical ethics. Scope of its practice is composed of statutory and individual components, includes codes of ethics and other resources. As the Quality Management Center of Clinical Nutrition in Jiangsu, it is the system`s responsibility to standardize and improve the professional performance within the province`s tertiary hospitals. Their quality assessment comes from the reported data of all CND among these hospitals, such as human and material resource, professional practice, foodservice operation, patient`s satisfaction, and nutrition education presentation for hospital and community. Within this information era, most of the current information is network-based, as well as the data of healthcare. An electronic system that automatically collects medical information can realize timely monitoring of patient health, improve the effectiveness and accuracy of medical treatment. From a medical quality perspective, a reliance intelligent management system can improve data curation, reduce human resource costs, and contribute to facilitating continuous improvement. As one of the inventions in the information era, AI shows its strong adaptability to the network-based health-care system. It can be introduced into clinical behavior detection accurately and automatically, and of great significance for reducing the incidence of treatment errors and ensuring patients safety. However, the amount of digital data has increased dramatically after the appliance of online system5. A crucial consequence is that data management has become more complex, which has increased the necessity for methods that are able to deal with the quality assessment of digital information. From the perspective of QM and the discipline development of a medical specialty, such as CN, the specific indicators and the application evaluation of AI are important to achieving quality control goals. To our knowledge, the application of AI into medical service quality assessment has merely been evaluated, especially for CND. There existed a unified platform for all the QM centers of various medical specialties set up by the Jiangsu Provincial Health Commission. After its broken-down in October 2017, the QMCNJ became the first center to independently develop and promote the application of its online platforms named “Jiangsu Province Clinical Nutrition Management Platform”. It was officially launched in the QMSNJ in 2019 and successfully promoted to 70 CND within the quality control system. They are required to fill in relevant information regularly in accordance with the regulations of “Strengthening the Management of Provincial Medical Quality Management System” formulated by JPHC, which has revised in September 2020. Since the stable application of this platform for two years, its effect in QM required to be validated. At the same time, the application value of AI and the development of the CND in Jiangsu can also be clarified. OBJECTIVE To critically evaluate the Quality Management System (QMS) for Clinical Nutrition (CN) in Jiangsu. Monitor its performance in quality assessment as well as human resource management from nutrition aspect. Investigate the appliance and development of Artificial Intelligence (AI) in medical quality control. METHODS Subjects: The study source of this research was all the staffs of 70 Clinical Nutrition Department (CND) of the tertiary hospitals in Jiangsu Province, China. These departments are all members of the Quality Management System of Clinical Nutrition in Jiangsu (QMSNJ). Methods: An online survey was conducted on all 341 employees within all these CNDs based on the staff information from the surveyed medical institutions. The questionnaire contains 5 aspects, while data analysis and AI evaluation were focused on human resource information. RESULTS 330 questionnaires were collected with the respondent rate of 96.77%. The QMS for CN has been build up for CNDs in Jiangsu, which achieved its target in human resource improvements, especially among dietitians. The increasing number of participated departments (42.8%) and the significant growth of dietitians (p=0.02, t=-0.42) are all expressions of the advancements of QMSNJ. CONCLUSIONS As the first innovation of an online platform for QM in Jiangsu, JPCNMP has been successfully implemented among QMS from this research. This multidimensional electronic system can help QMSNJ and CND achieve quality assessment from various aspects, so as to realize the continuous improvement of clinical nutrition. The instrument of online platform, as well as AI technology for quality assessment is worth to be recommended and promoted in the future.


Author(s):  
Gavin P Spickett

Introduction Structure of the NHS and the NHS plan Clinical Pathology Accreditation (CPA) Medicines and Healthcare Products Regulatory Authority (MHRA) Quality management system (QMS) Concepts of quality assurance in the laboratory Quality control (internal) Quality control (external) 1: EQA schemes Quality control (external) 2: benchmarking and CE marking...


2016 ◽  
Vol 5 (3) ◽  
pp. 62-82 ◽  
Author(s):  
Eleftherios Vavoulidis ◽  
Stavros Archondakis ◽  
Maria Nasioutziki ◽  
Ourania Oustambasidou ◽  
Angelos Daniilidis ◽  
...  

Modern cytopathology laboratories offer an outstanding portfolio of testing services that are vital for patients. Due to their clinical importance, such laboratories have to provide results of high quality and credibility. Accreditation status and the implementation of a Quality Management System according to ISO15189 requirements are usually the most effective strategies to reach the optimum quality standards. However, laboratory quality should be constantly monitored and assessed in order to avoid potential deviations from the pre-defined values. The design of a unified system of Quality Control and Assurance procedures that will guarantee excellent performance and results is essential. The authors present their experience on the implementation of such a system and describe in detail strategies for efficient quality management. Useful recommendations for the design of such a system are provided. Finally, a mobile health application that could potentially enhance the entire quality control and assurance system is also presented.


2013 ◽  
Vol 16 (2) ◽  
pp. 35-38
Author(s):  
Miroslav Prístavka ◽  
Marián Bujna

Abstract More and more organisations are beginning to realise how important is it to implement a quality management system. Its main task is to rejuvenate the given processes in production. Problem solving is systemic within quality assurance procedures of an organisation. This work describes a quality management system according to ISO 9001 and statistical methods in quality management. The theoretical part contains the characteristics and description of the system listed above. The practical part shows the use of knowledge in the organisation to solve problems.


2017 ◽  
Vol 7 (1) ◽  
pp. 54
Author(s):  
Ivana Čandrlić - Dankoš

According to the international requirements of ISO 9001:2015, the conducting of the audit of the quality control system is a key prerequisite for checking the compliance of the system with the international standards requirements and the requirements of the organization's quality management system that applies them. The results of conducted internal audits contain information related to irregularities (noncompliance with the required norms), and recommendations for improvement, all of it aimed towards improving the existing business practices. Simultaneously, the analysis of the position of the Republic of Croatia on international competitiveness charts shows a significant lag in relation to the countries of Central and Eastern Europe. The analysis of the comparison of the Republic of Croatia with other countries based on the analysis of international competitiveness shows lagging in all segments of competitiveness. Consequently, in line with the recommendations of the European Commission as part of the convergence program of national reforms in the Republic of Croatia, the weakness of the system is also reflected in the (non) efficiency of the public sector that needs to be improved. The work of local and regional self-government units (hereinafter referred to as management) in the Republic of Croatia is supervised by State administration bodies, institutions responsible for conducting business of legal and/or natural persons, assemblies in towns and counties, and within municipalities the municipal council as well as internal audit units and internal auditors if the management has implemented a quality management system according to one of the international standards. The question arises about the possibility of using audits as a form of quality management control as a strategic tool for improving the work of the administration, or more precisely the increasing of the efficiency of the system and raising the level of competitiveness. This paper gives a brief overview of the efficiency of the Croatian public administration presented through international competitiveness charts, an overview of the forms of work management oversight, with special emphasis on monitoring specificities according to the international standard ISO 9001:2015 and the Quality Control and Auditing Guidelines standard methodology and the ISO / IEC 19011: 2012. Professional and scientific literature regarding the experiences and the role of internal auditing in public administration has been consulted. The concluding remarks analyze the possibilities of using internal audits as the basis for improving the quality of the management system.


Author(s):  
Lisa Bremanti ◽  
Musa Hubeis ◽  
Nurheni Sri Palupi

Boiled fish is a processing of fishery products that have great potential because of high public demanding. UMKM Cindy Group is a small and medium enterprise in Bogor regency who wished that their product could be competitive, so that the application of quality management is required. The objectives of this research were: (1) to identify the level of quality management implementation at traditional and hygienic boiled fish SMEs as well as; (2) to analyze the relation of the level of quality application to the performance of traditional and hygienic boiled fish SMEs. The method used was descriptive analysis; trend analysis (financial performance: Net Profit Margin (NPM), Return on Investment (ROI), Return on Equity (ROE) and non-financial performance (number of training, production volume, number of customers); and discriminant analysis. Sampling technique for filling questionnaire was purposive sampling. The results of the study found that the level of application of quality management system at traditional boiled fish was at the level between Quality Control Operator (OQC) and Foreman Quality Control (FQC), while hygienic cleansing was at the level between Statistic Quality Control (SQC) and Total Quality Management (TQM). The result of discriminant analysis show that the level of SMM implementation has an effect on the company performance of UD Cindy Group that was seen from sig value <0.05. On hygienic displacement had an increasing trend of non-financial performance and higher on the average of the last three years compared with traditional boiled fish


Author(s):  
O. A. Lobovikova ◽  
I. V. Shul'gina ◽  
A. K. Nikiforov

Developed are the methodical approaches for design and implementation of quality management system(QMS) in the production of preventive and diagnostic medical immunobiological preparations manufactured at the Russian Research Anti-Plague Institute Microbe. Analyzed and generalized is the current legislative-normative framework of Russian Federation in the sphere of quality control and quality assurance. Factors influencing the quality management system are revealed. QMS is certified in conformity with the requirements of international standard ISO 9001.


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