Search results for: sterility and safety in pharmaceutical development

Authors: Michael Leontiev, Danil Zhilikov, Dmitry Lobanov, Lenar Klimov, Vyacheslav Chertan, Daniel Bobrov, Vladislav Maslov, Vasilii Vologdin, Ksenia Balabaeva

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Pharmaceutical manufacturing is a complex process, where each stage requires a high level of safety and sterility. Personal Protective Equipment (PPE) is used for this purpose. Despite all the measures of control, the human factor (improper PPE wearing) causes numerous losses to human health and material property. This research proposes a solid computer vision system for ensuring safety in pharmaceutical laboratories. For this, we have tested a wide range of state-of-the-art object detection methods. Composing previously obtained results in this sphere with our own approach to this problem, we have reached a high accuracy ([email protected]) ranging from 0.77 up to 0.98 in detecting all the elements of a common set of PPE used in pharmaceutical laboratories. Our system is a step towards safe medicine production.

Keywords: sterility and safety in pharmaceutical development, personal protective equipment, computer vision, object detection, monitoring in pharmaceutical development, PPE

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Authors: Abdul Wakeel, Hafeez Ur Rehman, Muhammad Umair Mubarak

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Rice is the second most important staple food in Pakistan after wheat. It is not only a healthy food for the people of all age groups but also a source of foreign exchange for Pakistan. Instead of bright history for Basmati rice production, we are suffering from multiple problems reducing yield and quality as well. Rice lodging and water shortage for an-aerobic rice production system is among major glitches of it. Due to water shortage an-aerobic rice production system has to be supplemented or replaced by aerobic rice system. Aerobic rice system has been adopted for production of non-basmati rice in many parts of the world. Also for basmati rice, significant efforts have been made for aerobic rice production, however still has to be improved for effective recommendations. Among two major issues for aerobic rice, weed elimination has been solved to great extent by introducing suitable herbicides, however, low yield production due weak grains and panicle sterility is still elusive. It has been reported that potassium (K) has significant role to decrease panicle sterility in cereals. Potassium deficiency is obvious for rice under aerobic rice production system due to lack of K gradient coming with irrigation water and lowered indigenous K release from soils. Therefore it was hypothesized that K application under aerobic rice production system may improve the rice yield by decreasing panicle sterility. Results from pot and field experiments confirm that application of K fertilizer significantly increased the rice grain yield due to decreased panicle sterility and improving grain health. The quality of rice was also improved by K fertilization.

Keywords: DSR, Basmati rice, aerobic, potassium

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Authors: Adegoke Yinka Adebayo

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An understanding of the critical product attributes that impact on in vivo performance is key to the production of safe and effective medicines. Thus, a key driver for our research is the development of new basic science and technology underpinning the development of new pharmaceutical products. Research includes the structure and properties of drugs and excipients, biopharmaceutical characterisation, pharmaceutical processing and technology and formulation and analysis.

Keywords: drug discovery, drug development, drug delivery

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Authors: Doris Lacej, Eni Bushi

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Cleaning and disinfection procedures are essential for maintaining the cleanliness status of the pharmaceutical manufacturing environment particularly of the cleanrooms and sterile unit area. The Good Manufacturing Practice (GMP) Annex 1 recommendation highly requires the implementation of the standard and validated cleaning and disinfection protocols. However, environmental monitoring has shown that even a validated cleaning method with certified agents may result in the presence of atypical microorganisms’ colony that exceeds GMP limits for a specific cleanroom area. In response to this issue, this case study aims to arrive at the root cause of the microbial contamination observed in the sterile production environment in Profarma pharmaceutical industry in Albania through applying a problem-solving practical approach that ensures the appropriate sterility grade. The guidelines and literature emphasize the importance of several factors in the prevention of possible microbial contamination occurring in cleanrooms, grade A and C. These factors are integrated into a practical framework, to identify the root cause of the presence of Aspergillus Niger colony in the sterile production environment in Profarma pharmaceutical industry in Albania. In addition, the application of a semi-automatic disinfecting system such as H2O2 FOG into sterile grade A and grade C cleanrooms has been an effective solution in eliminating the atypical colony of Aspergillus Niger. Selecting the appropriate detergents and disinfectants at the right concentration, frequency, and combination; the presence of updated and standardized guidelines for cleaning and disinfection as well as continuous training of operators on these practices in accordance with the updated GMP guidelines are some of the identified factors that influence the success of achieving sterility grade. However, to ensure environmental sustainability it is important to be prepared for identifying the source of contamination and making the appropriate decision. The proposed case-based practical approach may help pharmaceutical companies to achieve sterile production and cleanliness environmental sustainability in challenging situations. Apart from the integration of valid agents and standardized cleaning and disinfection protocols according to GMP Annex 1, pharmaceutical companies must be careful and investigate the source and all the steps that can influence the results of an abnormal situation. Subsequently apart from identifying the root cause it is important to solve the problem with a successful alternative approach.

Keywords: cleanrooms, disinfectants, environmental monitoring, GMP Annex 1

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Authors: Clara T. Fatoye, April Betts, Abayomi Odeyemi, Francis A. Fatoye, Isaac O. Odeyemi

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Background: The post-launch stage is the last stage in the development of a pharmaceutical product. It is important to involve patients in the development of pharmaceutical products at the post-launch stage, as patients are the end-users of pharmaceutical products. It is expected that involving them might ensure an effective working relationship among the various stakeholders. However, involving patients in the development of pharmaceutical products comes with its problems. Hence, this study examined how to resolve problems experienced by involving patients in the developments of pharmaceutical products’ at post-launch consisting of Positioning of pharmaceutical products (POPP), detailing of pharmaceutical products (DOPP) and reimbursement and Formulary Submission (R&FS). Methods: A questionnaire was used for the present study. It was administered at the ISPOR Glasgow 2017 to 104 participants, all of which were professionals from Market access (MA) and health economics and outcomes research (HEOR) backgrounds. They were asked how the issues experienced by patients can be resolved. Participants responded under six domains as follows: communication, cost, effectiveness, external factors, Quality of life (QoL) and safety. Thematic analysis was carried out to identify strategies to resolve issues experienced by patients at the post-launch stage. Results: Three (3) factors cut across at POPP, DOPP, and R&FS that is (external factors, communication and QoL). The first resolution method was an external factor that is, the relationship with stakeholders and policymakers. Communication was also identified as a resolution method that can help to resolve problems experienced by patients at the post-launch stage. The third method was QoL as perceived by the patients based on professionals’ opinions. Other strategies that could be used to resolve problems experienced were the effectiveness of pharmaceutical products at the DOPP level and cost at R&FS. Conclusion: The study showed that focusing on external factors, communication, and patients’ QoL are methods for resolving issues experienced by involving patients at the post-launch stage of pharmaceutical product development. Hence, effective working relationships between patients, policymakers and stakeholders may help to resolve problems experienced at the post-launch stage. Healthcare policymakers are to be aware of these findings as they may help them to put appropriate strategies in place to enhance the involvement of patients in pharmaceutical product development at the post-launch stage, thereby improving the health outcomes of the patients.

Keywords: patients, pharmaceutical products, post-launch stage, quality of life, QoL

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Authors: Gule Teri

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The effective validation of analytical methods forms a crucial component of pharmaceutical manufacturing. However, traditional validation techniques can occasionally fail to fully account for inherent variations within datasets, which may result in inconsistent outcomes. This deficiency in validation accuracy is particularly noticeable when quantifying low concentrations of active pharmaceutical ingredients (APIs), excipients, or impurities, introducing a risk to the reliability of the results and, subsequently, the safety and effectiveness of the pharmaceutical products. In response to this challenge, we introduce an enhanced, tolerance-based Design of Experiments (DoE) approach for the validation of analytical methods. This approach distinctly measures variability with reference to tolerance or design margins, enhancing the precision and trustworthiness of the results. This method provides a systematic, statistically grounded validation technique that improves the truthfulness of results. It offers an essential tool for industry professionals aiming to guarantee the accuracy of their measurements, particularly for low-concentration components. By incorporating this innovative method, pharmaceutical manufacturers can substantially advance their validation processes, subsequently improving the overall quality and safety of their products. This paper delves deeper into the development, application, and advantages of this tolerance-based DoE approach and demonstrates its effectiveness using High-Performance Liquid Chromatography (HPLC) data for verification. This paper also discusses the potential implications and future applications of this method in enhancing pharmaceutical manufacturing practices and outcomes.

Keywords: tolerance-based design, design of experiments, analytical method validation, quality control, biopharmaceutical manufacturing

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Authors: Ahsan Ali Khan

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During past few years, researchers are emphasizing more on the need of safety in construction industry. This need of safety is an important issue in developing countries. As due to development they are facing huge construction growth. This research is done to evaluate labor safety condition in construction industry of Pakistan. The research carried out through questionnaire survey at different construction sites. Useful data are gathered from these sites which then factor analyzed resulting in five factors. These factors reflect that most of the workers are aware of the safety need, but they divert this responsibility towards management and claim that the work is more essential for management instead of safety. Moreover, those work force which is unaware of safety state that there is lack of any training and guidance from upper management which lead to many unfavorable events on construction sites. There is need of implementation safety activities by management like training, formulation of rules and policies. This research will be helpful to divert management attention towards safety need so they will make efforts for safety of their manpower—the workers.

Keywords: labor's safety, management role, Pakistan, safety factors

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Authors: Zeeshan Hamid, Asher Ramish

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The purpose of this paper is to focus on security and safety issues facing by pharmaceutical industry globally when counterfeit drugs are in question. Hence, there is an intense need to secure and authenticate pharmaceutical products in the emerging counterfeit product market. This paper will elaborate the application of radio frequency identification (RFID) in pharmaceutical industry and to identify its key benefits for patient’s care. The benefits are: help to co-ordinate the stream of supplies, accuracy in chains of supplies, maintaining trustworthy information, to manage the operations in appropriate and timely manners and finally deliver the genuine drug to patient. It is discussed that how RFID supported supply chain information sharing (SCIS) helps to combat against counterfeit drugs. And a solution how to tag pharmaceutical products; since, some products prevent RFID implementation in this industry. In this paper, a proposed model for pharma industry distribution suggested to combat against the counterfeit drugs when they are in supply chain.

Keywords: supply chain, RFID, pharmaceutical industry, counterfeit drugs, patients care

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Authors: Nerella Srinivas

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This study investigates the role of intellectual property (IP) management in pharmaceutical development, focusing on tools, strategies, and business models for leveraging IP effectively. Using a mixed-methods approach, we conducted case studies and qualitative analyses of IP management frameworks within the pharmaceutical sector. Our methodology included a review of IP tools tailored for pharmaceutical applications, strategic IP models for maximizing competitive advantages, and best practices for organizational efficiency. Findings emphasize the importance of understanding IP law and adopting adaptive strategies, illustrating how IP management can drive industry growth.

Keywords: intellectual property management, pharmaceutical products, IP tools, IP strategies, best practices, business models, innovation

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Authors: Dina Alfreahat, Zoltan Sebestyen

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Safety is considered as one of the project’s success factors. Poor safety management may result in accidents that impact human, economic, and legal issues. Therefore, it is necessary to consider safety and health as a project success factor along with other project success factors, such as time, cost, and quality. Organizations have a knowledge deficit of the implementation of long-term safety practices, and due to cost control, safety problems tend to receive the least priority. They usually assume that safety management involves expenditures unrelated to production goals, thereby considering it unnecessary for profitability and competitiveness. The purpose of this study is to introduce, analysis and identify the correlation between the orientation of the public safety procedures of an organization and the public safety standards applied in the project. Therefore, the authors develop the process and collect the possible mathematical-statistical tools supporting the previously mentioned goal. The result shows that the adoption of management to safety is a major factor in implementing the safety standard in the project and thereby improving safety performance. It may take time and effort to adopt the mindset of safety orientation service development, but at the same time, the higher organizational investment in safety and health programs will contribute to the loyalty of staff to safety compliance.

Keywords: project management perspective, safety orientation, safety performance, safety standards

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Authors: Efua Ehiaguina, Haruna Moda

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Interest in the development of appropriate safety culture in the oil and gas industry has taken centre stage among stakeholders in the industry. Human behaviour has been identified as a major contributor to occupational accidents, where abnormal activities associated with safety management are taken as normal behaviour. Poor safety culture is one of the major factors that influence employee’s safety behaviour at work, which may consequently result in injuries and accidents and strengthening such a culture can improve workers safety performance. Nigeria oil and gas industry has contributed to the growth and development of the country in diverse ways. However, in terms of safety and health of workers, this industry is a dangerous place to work as workers are often exposed to occupational safety and health hazard. To ascertain the impact of employees’ safety and how it impacts health and safety compliance within the local industry, online safety culture survey targeting frontline workers within the industry was administered covering major subjects that include; perception of management commitment and style of leadership; safety communication method and its resultant impact on employees’ behaviour; employee safety commitment and training needs. The preliminary result revealed that 54% of the participants feel that there is a lack of motivation from the management to work safely. In addition, 55% of participants revealed that employers place more emphasis on work delivery over employee’s safety on the installation. It is expected that the study outcome will provide measures aimed at strengthening and sustaining safety culture in the Nigerian oil and gas industry.

Keywords: oil and gas safety, safety behaviour, safety culture, safety compliance

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Authors: Hassan Noun, Christian Urban-Seelmann, Mohamed Abdelfattah, Guillaume Zeller, Rajesh G., Iryna Mozgova, Roland Lachmayer

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Several modules in automotive are usually modified and adapted for various project-specific applications. Due to a standardized safety concept, high reusability is accessible. A safety element out of context (SEooC) according to ISO 26262 can be a suitable approach. Based on the same safety concept and analysis, common modules can reach high usability. For developing according to a module out of context, an appropriate and detailed development approach is required. This paper shows how to derive these development processes for platform modules. Therefore, the detailed approach to the safety element out of context is derived. The aim is to create a detailed workflow for all phases of the development and integration of any kind of system modules. As an application example, an automotive project for an actuator control module is considered.

Keywords: functional safety, engineering processes, system engineering, electronic engineering

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Authors: Miklos Taliga

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In the present case study we examined the development and testing methods of systems that contain safety-critical elements in different industrial fields. Consequentially, we observed the classical object-oriented development and testing environment, as both medical technology and automobile industry approaches the development of safety critical elements that way. Subsequently, we examined model-based development. We introduce the quality parameters that define development and testing. While taking modern agile methodology (scrum) into consideration, we examined whether and to what extent the methodologies we found fit into this environment.

Keywords: safety-critical elements, quality managent, unit verification, model base testing, agile methods, scrum, metamodel, object-oriented programming, field specific modelling, sprint, user story, UML Standard

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Authors: Preeda Sansakorn, Min An

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In order to be capable of dealing with uncertainties, subjectivities, including vagueness arising in building construction projects, the application of fuzzy reasoning technique based on fuzzy set theory is proposed. This study contributes significantly to the development of a fuzzy reasoning safety risk assessment model for building construction projects that could be employed to assess the risk magnitude of each hazardous event identified during construction, and a third parameter of probability of consequence is incorporated in the model. By using the proposed safety risk analysis methodology, more reliable and less ambiguities, which provide the safety risk management project team for decision-making purposes.

Keywords: safety risk assessment, building construction safety, fuzzy reasoning, construction risk assessment model, building construction projects

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Authors: Mohammad Rajabalinejad

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Safety is often seen as a requirement or a performance indicator through the design process, and this does not always result in optimally safe products or systems. This paper suggests integrating the best safety practices with the design process to enrich the exploration experience for designers and add extra values for customers. For this purpose, the commonly practiced safety standards and design methods have been reviewed and their common blocks have been merged forming Safety Cube. Safety Cube combines common blocks for design, hazard identification, risk assessment and risk reduction through an integral approach. An example application presents the use of Safety Cube for design of machinery.

Keywords: safety, safety cube, product, system, machinery, design

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Authors: Jasper C. Dioco

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The study was done to investigate the relationship of taxi company safety climate and drivers’ safety motivation and knowledge on taxi drivers’ safety performance. Data were collected from three Taxi Companies with taxi drivers as participants (N = 84). The Hiligaynon translated version of Transportation Companies’ Climate Scale (TCCS), Safety Motivation and Knowledge Scale, Occupational Safety Motivation Questionnaire and Global Safety Climate Scale were used to study the relationships among four parameters: (a) Taxi company safety climate; (b) Safety motivation; (c) Safety knowledge; and (d) Safety performance. Correlational analyses found that there is no relation between safety climate and safety performance. A Hierarchical regression demonstrated that safety motivation predicts the most variance in safety performance. The results will greatly impact how taxi company can increase safe performance through the confirmation of the proximity of variables to organizational outcome. A strong positive safety climate, in which employees perceive safety to be a priority and that managers are committed to their safety, is likely to increase motivation to be safety. Hence, to improve outcomes, providing knowledge based training and health promotion programs within the organization must be implemented. Policy change might include overtime rules and fatigue driving awareness programs.

Keywords: safety climate, safety knowledge, safety motivation, safety performance, taxi drivers

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Authors: Murat Gunduz, Mustafa Ozdemir

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In this research, a framework is to be proposed to model the safety performance in construction sites. Determinants of safety performance are to be defined through extensive literature review and a multidimensional safety performance model is to be developed. In this context, a questionnaire is to be administered to construction companies with sites. The collected data through questionnaires including linguistic terms are then to be defuzzified to get concrete numbers by using fuzzy set theory which provides strong and significant instruments for the measurement of ambiguities and provides the opportunity to meaningfully represent concepts expressed in the natural language. The validity of the proposed safety performance model, relationships between determinants of safety performance are to be analyzed using the structural equation modeling (SEM) which is a highly strong multi variable analysis technique that makes possible the evaluation of latent structures. After validation of the model, a safety performance index assessment tool is to be proposed by the help of software. The proposed safety performance assessment tool will be based on the empirically validated theoretical model.

Keywords: Fuzzy set theory, safety performance assessment, safety index, structural equation modeling (SEM), construction sites

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Authors: Ilham Benali, Nasser Hajji, Nawfel Acha

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The pharmaceutical sector is ongoing different constraints related to the Research and Development (R&D) costs, the patents extinction, the demand pressing, the regulatory requirement and the generics development, which drive leading firms in the sector to undergo technological change and to shift to biotechnological paradigm. Based on a large literature review, we present a background of innovation trajectory in pharmaceutical industry and reasons behind this technological transformation. Then we investigate the role that Information and Communication Technology (ICT) is playing in this revolution. In order to situate pharmaceutical firms in developing countries in this trajectory, and to examine the degree of their involvement in the innovation process, we did not find any previous empirical work or sources generating gathered data that allow us to analyze this phenomenon. Therefore, and for the case of Morocco, we tried to do it from scratch by gathering relevant data of the last five years from different sources. As a result, only about 4% of all innovative drugs that have access to the local market in the mentioned period are made locally which substantiates that the industrial model in pharmaceutical sector in developing countries is based on the 'license model'. Finally, we present another alternative, based on ICT use and big data tools that can allow developing countries to shift from status of simple consumers to active actors in the innovation process.

Keywords: biotechnologies, developing countries, innovation, information and communication technology, pharmaceutical firms

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Authors: Abdel Qader Al Bawab, Mohannad Odeh, Rami Amer

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Recently, there has been an increasing interest in innovative business development. Nevertheless, in the pharmacy practice field, there seems to be a gap in perceptions, attitudes, and knowledge about innovation between practicing pharmacists and academia. This study explores this gap and aspects of pharmaceutical innovation in Jordan, comparing pharmacists and last-year pharmacy students. A validated (r2 = 0.74) and reliable (Pearson’s r = 0.88) online questionnaire was designed to assess and compare knowledge, attitude, and perceptions about pharmaceutical innovation. A total of 397 participants (215 pharmacy students and 182 pharmaceutical professionals) responded. Compared with 50% of the pharmacists, only 32.1% of the students claimed that they knew the differences between pharmaceutical innovation, discovery, invention, and entrepreneurship [x2 (2) = 14.238, p = 0.001; Cramer’s V = 0.189]. Pharmacists demonstrated a higher level of trust in the innovative website design for their institution compared with students (25.3% vs. 16.3%, p < 0.001, Cramer’s V = 0.327). However, 60% of the students did not know the innovative design standards for websites, while the corresponding percentage was 37% for the pharmacists (p < 0.001; Cramer’s V = 0.327). The majority of the students were interested in pharmaceutical innovation (81.9%). Unfortunately, 76.3% never studied innovation in their pharmacy curricula. Similarly, most pharmacists (76.4%) considered adopting innovation, but only 30% had a concrete plan. For the field where pharmacists aim to innovate in the next 5 years, new pharmaceutical services were the dominant field (34.6%). Despite a positive attitude and perception, pharmacists and pharmacy students expressed poor knowledge about innovation. Policies to enhance awareness about innovation and professional educational tools should be implemented.

Keywords: pharmacy, innovation, knowledge, attitude, practice

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Authors: Yirui Wang

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In the past few decades, patient safety has been the focus of much attention in the global medical and health field. As medical standards continue to improve and develop, the demand for patient safety is also growing. As one of the important dimensions in assessing patient safety, the Patient Perception Patient Safety Assessment Tool provides unique and valuable information from the patient's own perspective and plays an important role in promoting patient safety. This article aims to summarize and analyze the assessment content, assessment methods and applications of currently commonly used patient-perceived patient safety assessment tools at home and abroad, with a view to providing a reference for medical staff to select appropriate patient-perceived patient safety assessment tools.

Keywords: patients, patient safety, perception, assessment tools, review

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Authors: Hyun Chul Koag, Hyun-Sik Ahn

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In this paper, we propose a design approach for the safety mechanism of an actuator used in a commercial vehicle’s EPS system. As the number of electric/electronic system in a vehicle increases, the importance of the functional safety has been receiving much attention. EPS(Electric Power Steering) systems for commercial vehicles require large power than passenger vehicles, and hence, dual motor can be applied to get more torque. We show how to formulate the development process for the design of hardware and software of an EPS system using dual motors. A lot of safety mechanisms for the processor, sensors, and memory have been suggested, however, those for actuators have not been fully researched. It is shown by metric analyses that the target ASIL(Automotive Safety Integrated Level) is satisfied in the point of view of hardware of EPS controller.

Keywords: safety mechanism, functional safety, commercial vehicles, electric power steering

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Authors: A. Orlov, V. Rachkov

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The future of Nuclear Energetics is seen in fast reactors with inherent safety working in the closed nuclear fuel cycle. The concept of inherent safety, which lies in deterministic elimination of the most severe accidents due to inherent properties of the reactor rather than through building up engineered barriers, is a cornerstone of success in ensuring safety and economic efficiency of future Nuclear Energetics. The focus of this paper is one of the key elements of inherent safety - the lead coolant of a nuclear reactor. Advantages of lead coolant for reactor application, influence on safety are reviewed. BREST-OD-300 fast reactor, currently being developed in Russia withing the “Proryv” Project utilizes lead coolant and a special set of measures and devices, called technology of lead coolant that ensures safe operation in a wide range of temperatures. Here these technological elements are reviewed, and current progress in their development is discussed.

Keywords: BREST-OD-300. , fast reactor, inherent safety, lead coolant

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Authors: Yogesh Mahor, Subhash Nigam, Abhai Khare

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Road safety education is a composite subject which should be viewed holistically if taken into accoubehavior change communication, safe road infrastructure and low enforcement. Specific and customized road safety education is crucial for each type of road user and learners in the formal and informal teaching and various kind of training programs directly sponsored by state and center government, as they are active contributors to shaping a community and responsible citizens. The aim of this discussion article is to explore a strategy to integrate road safety education into the formal curriculum of schools, higher education institutions, driving schools, skill development centers, various government funded urban and rural development training institutions and their work plans as standing agenda. By applying the desktop research method, the article conceptualizes what the possible focus of road safety education and training should be. The article then explores international common practices in road safety education and training, and considers the necessary synergy between education, road engineering and low enforcement. The article uses secondary data collected from documents which are then analysed in a sectoral way. A well-designed road safety strategy for mainstreaming education and government-sponsored training is urgently needed, facilitating partnerships in various sectors to implement such education in the students and learners in multidisciplinary ways.

Keywords: road safety education, curriculum-based road safety education, behavior change communication, low enforcement, road engineering, safe system approach, infrastructure development consultants

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Authors: Muhammad Ajmal, Ahmad Shahrul Nizam Bin Isha, Shahrina Md. Nordin, Paras Behrani, Al-Baraa Abdulrahman Al-Mekhlafi

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This study aims to investigate the impact of safety management practices via safety compliance on occupational injuries in the context of downstream the oil and gas industry of Malaysia. However, it is still challenging for researchers and academicians to control occupational injuries in high-safety-sensitive organizations. In this study response rate was 62%, and 280 valid responses were used for analysis through SmartPLS. The study results revealed that safety management practices (management commitment, safety training, safety promotion policies, workers’ involvement) play a significant role in lowering the rate of accidents in downstream the oil and gas industry via safety compliance. Furthermore, the study results also revealed that safety management practices also reduce safety management costs of organizations, e.g., lost work days and employee absenteeism. Moreover, this study is helpful for safety leaders and managers to understand the importance of safety management practices to lower the ratio of occupational injuries.

Keywords: safety management, safety compliance, occupational injuries, oil and gas, Malaysia

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Authors: Gifty Kumadey, Albert Tchey Agbenyegah

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This study explores the role of stakeholders in developing a sustainable supply chain policy framework in Ghana's pharmaceutical industry. It employs a qualitative research design to analyze policy documents, academic articles, and reports, shedding light on stakeholder involvement. The findings highlight the contributions of government agencies, regulatory bodies, pharmaceutical companies, suppliers, and civil society organizations. Key policies such as green procurement, waste management, and recycling initiatives are identified. However, challenges such as limited transparency, supplier engagement, and regulatory complexity impede implementation. The study recommends strengthening collaboration and promoting transparency to overcome these challenges. The findings provide valuable insights for policymakers, industry stakeholders, and researchers seeking to advance sustainable supply chain practices in Ghana's pharmaceutical industry.

Keywords: stakeholders, sustainable supply chain, policy framework, pharmaceutical industry

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Authors: Saadan Man, Razidah Othmanjaludin, Madiha Baharuddin

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Nowadays, the pharmaceutical products are produced through the mixing of active and complex ingredient, naturally or synthetically; and involve extensive use of prohibited animal products. This article studies the challenges faced from fiqh perspective in the production of halal pharmaceutical products which frequently contain impure elements or prohibited animal derivatives according to Islamic law. This study is qualitative which adopts library research as well as field research by conducting series of interviews with the several related parties. The gathered data is analyzed from Sharia perspective by using some instruments especially the principle of Maqasid of Sharia. This study shows that the halal status of pharmaceutical products depends on the three basic elements: the sources of the basic ingredient; the processes involved in three phases of production, i.e., before, during and after; and the possible effects of the products. Various fiqh challenges need to be traversed in producing halal pharmaceutical products including the sources of the ingredients, the logistic process, the tools used, and the procedures of productions. Thus, the whole supply chain of production of pharmaceutical products must be well managed in accordance to the halal standard.

Keywords: fiqh, halal pharmaceutical, pharmaceutical products, Malaysia

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Authors: Elena A. Troubitsyna

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Designers of modern safety-critical control systems are increasingly relying on networking to provide the systems with advanced functionality and satisfy customer’s needs. However, networking nature of modern control systems also brings new technological challenges associated with ensuring system safety in the presence of openness and hence, potential security threats. In this paper, we propose a methodology that relies on systems-theoretic analysis to enable an integrated analysis of safety and security requirements of controlling software. We demonstrate how to create a safety case – a structured argument about system safety – with explicit representation of both safety and security goals. Our approach provides the designers with a systematic approach to analysing safety and security interdependencies while designing safety-critical control systems.

Keywords: controlling software, integrated analysis, security, safety-security co-engineering

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Authors: Muhammad Tufail, Jawad Hussain, Hammad Hussain, Imran Hafeez, Naveed Ahmad

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Road safety performance index is a composite index which combines various indicators of road safety into single number. Development of a road safety performance index using appropriate safety performance indicators is essential to enhance road safety. However, a road safety performance index in developing countries has not been given as much priority as needed. The primary objective of this research is to develop a general Road Safety Performance Index (RSPI) for developing countries based on the facility as well as behavior of road user. The secondary objectives include finding the critical inputs in the RSPI and finding the better method of making the index. In this study, the RSPI is developed by selecting four main safety performance indicators i.e., protective system (seat belt, helmet etc.), road (road width, signalized intersections, number of lanes, speed limit), number of pedestrians, and number of vehicles. Data on these four safety performance indicators were collected using observation survey on a 20 km road section of the National Highway N-125 road Taxila, Pakistan. For the development of this composite index, two methods are used: a) Principal Component Analysis (PCA) and b) Equal Weighting (EW) method. PCA is used for extraction, weighting, and linear aggregation of indicators to obtain a single value. An individual index score was calculated for each road section by multiplication of weights and standardized values of each safety performance indicator. However, Simple Average technique was used for weighting and linear aggregation of indicators to develop a RSPI. The road sections are ranked according to RSPI scores using both methods. The two weighting methods are compared, and the PCA method is found to be much more reliable than the Simple Average Technique.

Keywords: indicators, aggregation, principle component analysis, weighting, index score

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Authors: Hong-Yi Kuo

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Leadership is a key factor of improving workplace safety, and there have been abundant of studies which support the positive effects of appropriate leadership on employee safety performance in the western academic. However, little safety research focus on the Chinese leadership style like paternalistic leadership. To fill this gap, the resent study aims to examine the relationship between authoritarian leadership (one of the ternary mode in paternalistic leadership) and safety outcomes. This study makes hypothesis on different levels. First, on the group level, as an authoritarian leader regards safety value as the most important tasks, there would be positive effect on group safety outcomes through strengthening safety group norms by the emphasis on etiquette. Second, on the cross level, when a leader with authoritarian style has high priority on safety, employees may more obey the safety rules because of fear due to emphasis on absolute authority over the leader. Therefore, employees may show more safety performance and then increase individual safety outcomes. Survey data would be collected from 50 manufacturing groups (each group with more than 5 members and a leader) and a hierarchical linear modeling analysis would be conducted to analyze the hypothesis. Above the predictive result, the study expects to be a cornerstone of safety leadership research in the Chinese academic and practice.

Keywords: safety leadership, authoritarian leadership, group norms, safety behavior, supervisor safety priority

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Authors: Muhammad Danyal Khan

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The standards of patentability are drawing a great impact upon medicine industry of Pakistan which is indirectly troubling the right to health of ordinary citizen. Globalization of intellectual property laws is directly impacting access to medicine for population in Pakistan. Pakistan has enacted Patent Ordinance 2000 to develop the standards of Patent laws in consonance with international commitments. Moreover, Pakistan is signatory to UN Millennium Development Goals (2000-2015), and three of them directly put stress upon the health standards. This article will provide a critical brief about implications of TRIPS Agreement on standards of health in Pakistan and will also propose a futuristic approach for the pharmaceutical industry. This paper will define the paradox of globalization and national preparedness on pharmaceutical patents utilizing industry statistics and case laws from Pakistan. Moreover, this work will contribute towards debate on access to medicine at legislative and interpretative levels that will further help development of equilibrium between pharmaceutical patents and right to health.

Keywords: TRIPS (Trade Related Intellectual Property Rights), patents, compulsory licensing, patent, lifesaving drugs, WTO, infringement

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