Evolution of clinical trials: a comprehensive analysis of ICH E6(R3) and integrated quality management systems in the pharmaceutical industry

Urgency of the research. With the development of information technology and new management practices, there has been a convergence and often a merger of quality management and information technology practices. At present, concepts based on the integration of quality management systems and automated information systems are becoming increasingly important.Actual scientific researches and issues analysis.In the process of researching specialized scientific and technical litera-ture, modern trends and problems of introduction of information technologies in the quality management system were analyzed.Uninvestigated parts of general matters defining. An unsolved problem is to ensure the quality of use of automated infor-mation systems at a pharmaceutical enterprise integrated into an enterprise quality management system based on the requirements of the international GMP standard and the Guidelines ST-N MOH 42-4.0: 2016 “Medicines. Good manufacturing practice".The research objective. The purpose is to systematically analyze the methodological foundations of quality assurance, through the introduction and use of AIS, aimed at creating favorable conditions for improving the efficiency of the quality management system in the pharmaceutical industry.The statement of basic materials. The issues of construction and improvement of quality management system based on existing technologies for automated production are considered. The structure of the computer quality management system and the mechanisms of its information support are determined. The methods of integration of specialized software systems are alsoanalyzed and the concept of integration of them into the quality management system is proposed.Conclusions.Based on the critical analysis, a number of unresolved problems related to the development, implementation and use of automated information systems based on international standards were separated, as well as the scientific hypothesis of the effective implementation and use of automated information systems integrated into the quality management system of the pharmaceutical enterprise was put forward.

Clinical Research in Neglected Tropical Diseases: The Challenge of Implementing Good Clinical (Laboratory) Practices.

The article is devoted to the study of theoretical and practical aspects of building an integrated quality management system at milk processing enterprises. It is proved that quality management is a continuous process of influencing production by consistently implementing logically interrelated functions to ensure quality. An integrated quality management system is a set of structures and procedures, processes and resources required to implement quality management. It should be an integral part of the enterprise management system and should provide the management of the organization and / or the consumer with confidence that the product or service will meet the established quality requirements. It is proved that in the process of making a decision on the organization’s quality management system, measures are defined and planned to achieve the goals. The combination of these activities makes up the plan of organizational activity. For each of the activities included in the plan, the conditions for implementation and responsibility for implementation are determined. Since the quality management system actually covers all areas of the organization, then, of course, the processes of creating and implementing a quality management system in the enterprise will be associated with a change in the organizational structure of management.

Newly emerging products which combine drugs, devices, and biologics are expected to provide new opportunities in bridging device and drug capabilities and establish synergies while bringing sophisticated combination products to consumers. The emergence of these novel products has triggered new regulatory, strategic, and technological challenges. While progress has been made at clarifying the issues that arise most frequently, regulatory authorities and product developers continue to struggle with complex regulatory and technical issues encompassing the development programs for combination products. A risk-based approach requires not only a strategy but also tools to define key indicators to measure specific risks. Key risk indicators (KRIs) and risk-based quality management systems should focus on safety of research subjects and data integrity. We analyzed current regulatory guidelines throughout the life cycle of combination products and compared old and new approaches to risk-based quality and compliance management for current good manufacturing practices and during pre-clinical and clinical phases of combination products development. Cause-effect analysis for two major risk categories in clinical trials with combination products was performed. The results of our analysis are based on observations from 15 clinical trials, which were conducted with combination products. Based on our findings, we proposed practical recommendations for the development of KRIs to improve conduct and ensure safety of research subjects in trials with combination products by utilizing risk-based quality management approach. Combination products, due to their specific nature, can increase risks while being tested in clinical trials. Metrics critical to risks and quality management should be linked to particular processes within development program for combination products. Ongoing collaboration between regulators, industry, and other stakeholders is essential to streamlining of the global combination entities development and approval process in a way that will produce safe and effective products for consumers.

Total quality management (TQM) system of higher education is related to formulating college functions, and implementing quality policy, objective and responsibilities. Higher education information resources and service quality system is continuously improved through comprehensive utilization of various quality management methods. This paper designs specific contents and implementation strategies for higher education to apply this system and finally point out tge possible problems and solutions during implementation of TQM system.

Background: Good Clinical Laboratory Practice (GCLP) is a standard that helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competencies and safety measures. Implementation of GCLP is influenced by existing resources and quality systems, thus laboratories in low- and middle-income countries may face additional challenges. Methods: This paper describes implementation of Good Clinical Laboratory Practice (GCLP) at the Kenya Medical Research Institute-Center for Microbiology Research (KEMRI-CMR) as part of a quality system to support medical research. This study employed assessment, twinning (institutional mentorship) model, conducting relevant training workshops and Kaizen 5S approaches to implement an effective quality management system using GCLP standard. This was achieved through a collaboration between the KEMRI/Wellcome Trust Research Programme (KWTRP) and KEMRI-CMR. The aim was compliance and continuous monitoring to meet international GCLP standards in a way that could be replicated in other research organizations. Results: Following a baseline assessment in March 2017, training, mentorship and a cycle of quality audit and corrective action using a Kaizen 5S approach (sorting, setting in order, shining, standardizing and sustaining) was established. Laboratory personnel were trained in writing standard operating procedures and analytical plans, microbiological techniques, and good documentation practice. Mid-term and exit assessments demonstrated significant declines in non-conformances across all GCLP elements. KEMRI-CMR achieved GCLP accreditation in May 2018 by Qualogy Ltd (UK). Conclusions: Involving all the laboratory personnel in implementation of quality management system processes is critical to success. An institutional mentorship (twinning) approach shows potential for future collaborations between accredited and non-accredited organizations to accelerate the implementation of high-quality management systems and continuous improvement.

Background: Good Clinical Laboratory Practice (GCLP) is a standard that helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competencies and safety measures. Implementation of GCLP is influenced by existing resources and quality systems, thus laboratories in low- and middle-income countries may face additional challenges. Methods: This paper describes implementation of GCLP at the Kenya Medical Research Institute-Center for Microbiology Research (KEMRI-CMR) as part of a quality system to support medical research. This study employed assessment, twinning (institutional mentorship) model, conducting relevant training workshops and Kaizen 5S approaches to implement an effective quality management system using GCLP standard. This was achieved through a collaboration between the KEMRI/Wellcome Trust Research Programme (KWTRP) and KEMRI-CMR. The aim was compliance and continuous monitoring to meet international GCLP standards in a way that could be replicated in other research organizations. Results: Following a baseline assessment in March 2017, training, mentorship and a cycle of quality audit and corrective action using a Kaizen 5S approach (sorting, setting in order, shining, standardizing and sustaining) was established. Laboratory personnel were trained in writing standard operating procedures and analytical plans, microbiological techniques, and good documentation practice. Mid-term and exit assessments demonstrated significant declines in non-conformances across all GCLP elements. KEMRI-CMR achieved GCLP accreditation in May 2018 by Qualogy Ltd (UK). Conclusions: Involving all the laboratory personnel in implementation of quality management system processes is critical to success. An institutional mentorship (twinning) approach shows potential for future collaborations between accredited and non-accredited organizations to accelerate the implementation of high-quality management systems and continuous improvement.

Introduction. In modern conditions, quality management systems are actively used as an effective economic management tool. It complies with the requirements and recommendations in the ISO 9000 series of international standards and serves as a cross-cutting structural element of the overall enterprise management system. It is based on a process approach, which is implemented through planning, provision, control and continuous improvement of quality in order to achieve strategic objectives. Purpose and methods. The purpose of the study is to analyse methodological approaches to the quality management system, study the current state of its implementation and regulatory and legal support based on the ISO 9000 series of standards in Ukraine, focusing on quality management of service and production activities of restaurant businesses. The research process used methods of logical generalisation, a systematic approach, and systemic-structural and functional analysis. Results. The article investigates methodological approaches to quality management of products and services in the restaurant business based on the international standards ISO 9000 series. Based on the research results, a thorough analysis of the current regulatory framework for quality management systems in accordance with international standards ISO 9000 series in Ukraine was conducted, which became the methodological basis for the research. The theoretical foundations and practical aspects of the formation of quality management and the patterns of development of key concepts, particularly TQM, which, combined with the requirements of ISO 9000, contributed to the formation of integrated quality management systems, were analysed. The quality management system as an economic tool for ensuring the efficiency of enterprises was analysed, and the process aspect of its implementation was revealed. The main reasons for implementing a quality management system in restaurant businesses are identified. Conclusions. The ISO 9000 series of international standards form a coherent system focused on effective quality management based on key management principles. The basis for the quality management system's functioning is implementing preventive measures to prevent non-conformities in restaurant businesses' service and production processes. Compliance with ISO 9000 requirements allows companies to demonstrate their ability to provide products and services that meet consumer expectations and mandatory regulatory requirements.

This article analyses the quality certification, standardization, market and technical barriers to trade relations problems. Certification system and quality management tools development in Lithuania and international context are also analysed. It gives a study of the processes in place designed to normalise international standards, technical regulations and rules in the light of current global economic conditions. The models of Market, standardization and certification relations, Standardization space and typology and National quality certification system are presented in the article. The resultant generalisations and suggestions have been made based on the author‘s research of Lithuanian enterprises. Worldwide economic globalisation processes and the development of international trade have necessitated rapid quality internationalisation processes, as they are crucial in defining the quality of a product or company. These processes mean that more countries are keeping to unified standards and technical regulations, quality and environmental management systems, quality satisfaction evaluation and certification procedures. With their help, it is hoped that not only will the quality of goods and services be assured on an international scale, but that their implementation will lead to the elimination of technical barriers to trade. The main task of this article is to analyze and systemize quality certification, standardization, regulation tools that are used in the Lithuania and international trade, and to present the providence of the more effective usage of them. Technical barriers to international trade are becoming increasingly pervasive because there is a lot of variance in how these technical rules are applied in manufacturing and agriculture, where, in order to guarantee the production of pure and healthy food products, many countries have come up with especially strict and restrictive rules. Given the existing complicated and nonuniform rules, their systematisation is very difficult to achieve. The author suggests technical barriers to trade be divided into five groups. The certification system of Lithuania involves products, organizations and employees conformity assessment. Apart from “traditional” quality (ISO 9001) and environment (ISO 14001) management systems Lithuanian companies use other systems – ISO 22000, ISO/IEC 20000 GMP, ISO/IEC 17021:2006, ISO/TS 16949, ISO/IEC 27001, CMMI, BRC Global Standard, etc. Vehicle technical inspection and jewellery quality hallmarking performed by Lithuanian Assay Office are also a part of product certification activity. It must be highlighted that enterprises in Lithuania do not certify their products to the conformity of EU quality mark (Key Mark) requirements and not develop environmental management system EMAS yet. Nowadays quality management systems (QMS) are implemented no only in business enterprises, but also in hospitals, high education institutions, police departments, city municipalities and other public sector institutions of Lithuania. Although the amount of organizations that use quality management systems ISO 9001 is rising in Lithuania still there are some problems to be solved. However quantitative evaluation of noted indicator is not very informative. That is why the author uses the relative index – the number of ISO 9001 certificates per 1000 citizen for better comparison. According to this index in the number of QMS certificates Lithuania wins behind against the USA, China and India, however signally falls against other new European Union countries. To reach the EU average of this index, Lithuania has to have more than 2000 certificated QMS. Thus, business organizations and state governmental institutions have every reason for the concern. The author provides recommendations for the development of the effective QMS, to improve all certification system of country and introduce the providences of quality management science development.

Baristand Industri Padang is an agency under control Ministry of Industry of Indonesia which it has a duty to serve the industries involving research activities, standardization and certification. To realize the programs, Baristand Industri Padang implemented a quality management system including ISO 9001, ISO/IEC 17025, ISO/IEC 17065, and KNAPPP 02. Nevertheless, it has been running separately. Therefore, quality of products not only proven by testing the final product, but also needed other evidence as a certificate that ensuring the quality of products. This research aims to design the Quality Management System for Baristand Industri Padang which it was implemented using life cycle methodology. Finding of this study revealed there was integration of ISO 9001, ISO/IEC 17025, ISO/IEC 17065, and KNAPPP 02 in the context of the structure of the process, documents, and organization. In the context of the structure of processes, it obtained four groups of primary process involving management, research and standardization, support, and improvement. Moreover, In terms of documentation, there was three levels of the document such as the document of strategic policy, quality guideline and procedures. While aspects of the organizational structure, the integration of quality management system required to develop the organizational structure that consist of Top Management, Technical Manager, Quality/Management Representative, Researcher and Administrative/Technical Staff. In addition, this study provided an integrated quality management information system including management of quality documents and quality records. Finally, the integrated quality management system and quality management information system has been designed to meet the expectations of the organization.

In the rapidly evolving field of clinical research, the effective management of data is paramount. A robust data management framework is essential for ensuring the integrity, security, and accessibility of data throughout the research lifecycle. This framework not only supports compliance with regulatory requirements but also enhances the efficiency and reliability of research outcomes. Developing a data management framework for a clinical research institution involves a comprehensive approach that integrates best practices in data collection, storage, processing, and analysis. It requires a thorough understanding of the unique challenges and needs of clinical research, including the handling of sensitive patient information, adherence to ethical standards, and the facilitation of collaborative research efforts. This framework introduces sets the stage for exploring the key components and strategies involved in creating an effective data management framework, highlighting its critical role in advancing clinical research and improving quality of research data throughout comprehensive data management processes. This is the result of a long-journey of studying the SCDM’s Good Clinical Data Management Practices (GCDMP©) (SCDM, 2013), ICH E6 (R2) Good clinical practice (ICH) and practical experiences of Data Managers of the Oxford University Clinical Research Unit.

A fundamental principle of project quality management is that quality is planned into project and not inspected through project. In the context of host communities in developing countries with mineral exploration activities construction projects and contracts generally is a key provider of employment in both short, medium and long term and particularly for the locals, therefore the incorporation of quality management systems in project life cycle is paramount for sustainable development. Ensuring project quality plays an important role in socio-economic development of people as it provides the most basic infrastructure that promotes economic activities. Quality management systems (QMS) has significant value relating to project quality and cost reduction and a comprehensive quality management culture can promote project success, mutual beneficial relationship and organisational sustainability. This study provides empirical findings emanating from local vendor(s) understanding, compliance and implementation of quality management systems in a multinational oil company (MNOC) community assisted projects. The study utilised SPSS version 22 for the statistical data analysis and Goodness-of-fit-test interrogated the assumption that contractors are not complying with quality management systems in project execution. The study found inter alia that 65% of the vendors are registered as closed corporation (sole proprietorship), 15% were limited liability companies, while 20% belong to other category such as subcontractors. Furthermore, 98% of the 222 respondent are yet to develop a quality manual and a conceptual nominated vendor system (NVS) project quality model was developed to improve the contract award and project management status quo, with emphasis on the need for integration of quality management systems in project life cycle for the oil and gas host communities.

When routine laboratories merge or are taken over by larger entities, their quality management systems usually need to be integrated. In many laboratories, quality management systems according to ISO/IEC 17025 are in place. The integration of the quality management systems is often advantageous in terms of efficiency of operations, reduction in number of processes and consequently amount of quality documentation. However, a number of practical problems, some of them hard to overcome, may be encountered. Examples are: how to deal with multi-site activities showing technical and/or cultural differences, how to merge historically different ways of working and how to overcome psychological resistance to change from laboratory staff. This paper demonstrates a way of working used in our organisation to integrate successfully the quality management systems of several laboratories under one quality management system. The laboratories were located in two different countries (Belgium and Italy) and had activities under ISO/IEC 17025, ISO/IEC 17043 and ISO Guide 34 accreditation. Involvement of the laboratory staff was essential for obtaining a fast and efficient integration.

Background: The quality policy for hospitals enrolled in 2009 by the Flemish government, is based on a ‘Quality-of-Care Triad’ consisting of accreditation, inspection and public reporting of quality indicators. Since 2021, an accreditation label no longer replaces governmental quality system inspection in Flanders. Today, hospitals have the opportunity to build their own quality management system, but questions are raised on the development of a sustainable one. To address this gap in existing research, we aimed to develop a conceptual model towards sustainable, integrated quality management and to implement this model in healthcare organisations. Methods: A multi-methods approach in co-design with 19 healthcare organisations is used to develop a conceptual model. Development phases based on literature and multistakeholder feedback are followed by implementation phases in a convenience sample of 19 organisations (living labs) and by validation of the models based on their recommendations. Results: Flanders Quality Model (FlaQuM) towards sustainable, integrated quality of care constitutes 1) a vision model, 2) a co-creation roadmap and 3) a learning consortium of livings labs. For the vision model, a validated measurement tool, the FlaQuM Quickscan, was developed to measure quality experiences from a multistakeholder perspective (patients and kin, professionals and primary care) and ensures that organisation’s quality vision is rethought from an integrated, multidimensional approach. The co-creation roadmap guides organisations to build their quality management system by focusing on six drivers and 19 buildings blocks. Organisation’s maturity in those drivers and building blocks can be mapped using two tools: the FlaQuM Maturity matrix and FlaQuM Co-creation scan. Those are developed in co-design by conducting 20 focus groups with 79 content experts. Every 18 months, the FlaQuM Quickscan, FlaQuM Maturity matrix and FlaQuM Co-creation scan will be disseminated in the living labs and results will be fed back in benchmarking reports. During learning sessions with the consortium of 19 living labs, consisting of coordinators and board members from each organisation, results of tools are discussed and recommendations are used to further validate FlaQuM. The consortium is based on the learning principles of the Breakthrough Improvement Collaborative. Conclusion: FlaQuM is a new, unique model towards sustainable, integrated quality management that includes a vision model, co-creation roadmap and a learning consortium of living labs. By focusing on building a shared quality vision pursued through co-creation with all healthcare stakeholders, the organisation’s desired maturity level can be reached. Practice implications: FlaQuM and the developed tools can guide researchers, policymakers, healthcare managers and clinicians to build a sustainable quality management system while focusing on commitment, ownership and engagement of healthcare stakeholders to quality. Next steps: Future research will focus on the evaluation of the implementation of FlaQuM in the living labs. The realistic evaluation model to explore the context (C) in which FlaQuM is implemented, to understand the mechanisms (M) of change and the define impact on certain outcomes (O), will support to understand if, how and why FlaQuM works. Studying barriers and facilitators to implement FlaQuM in living labs, will help to disseminate FlaQuM in various healthcare settings.

The comparative analysis of the iso 9001:2015 standard and Good Clinical Practice guidelines: the framework for improving management of clinical trialsThe principal concept of the ICH Q8, Q9 and Q10 guidelines is to encourage implementation of scientific and systematic approaches for quality assurance of pharmaceutical products. Clinical trials, which are the crucially important part of the pharmaceutical research and development process, are outside of these guidelines, and it actualizes the issue on introducing quality management into clinical trials.Aim. To analyze the ISO 9001 quality management methodology and the Addendum to GCP requirements in order to elaborate the methodical background for its combined use that will provide the effective work of the quality management system while achieving GCP compliance. Materials and methods. The methods of the comparative analysis, synthesis, generalization, abstraction and content analysis were used to determine the possibility of ISO 9001:2015 and ICH GCP integration.Results. The Addendum to GCPdemonstrates the conformity of its provisions with prominent trends of quality management confirmed by the ISO 9001:2015 standard. The Addendum to GCP declares that the quality management system should use a risk-based approach, which allows conducting clinical trials more efficiently.Conclusions. The ICH GCP framework can be easily and effectively integrated into the ISO 9001 quality management system of a particular clinical study, as well as in the entire system of quality assurance during the drug lifecycle. Further studies should be focused on development of the practical approaches and methods for implementation of the risk-based quality management in clinical trials.