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The purpose of this paper is to explore the good practice (GxP) and standardised management system integration within total quality management (TQM) paradigm in pharmaceutical sector in Serbia. Also, the impact of all interested parties on quality management has been assessed.

The cross-sectional study was performed, including different stakeholders within the pharmaceutical sector in Serbia: manufacturers, distributors, big pharma representative offices, as well as national regulatory authority. A survey instrument was developed, consisted of 16 questions, which were organised into four groups: questions in relation to implementation of ISO 9001, implementation of good distribution practice/good manufacturing practice, integration of management systems, and impact on TQM and business excellence. Total number of participants was 121.

Standardised management systems (ISO 9001, ISO 14001, OHSAS 18001) support companies to improve business environment and management sustainability, but this survey indicated that it was ranked at the lower level then GxP, for pharmaceutical sector in Serbia. Although pharmaceutical companies has faced many challenges in recent years, the survey revealed high level of confidence in quality management systems, as well as the necessity of various management systems integration.

The perception of TQM by the experts in pharmaceutical companies and regulatory authority is wider than the common TQM definition. From pharmaceutical point of view, TQM is a holistic approach to long-term success of organisation, oriented to all interested parties, with focus on a public health. Risk-based approach in new revision of both ISO and GxP will facilitate integration process towards TQM and business excellence.

The objective of the study is to examine the extent to which pharmaceutical companies in India rely on traditional planning approaches rather than the new learning approach to strategic planning. In addition to that, the study also seeks to examine the perceived ability of the pharmaceutical companies in India to integrate continuous improvement goals and product quality into the overall strategic planning and success in implementing total quality management (TQM) programs examined through three particular continuous improvement mindsets.

The study collected data from select pharmaceutical companies in India through survey technique using a standardized questionnaire through online mode. A descriptive statistical analysis is performed to examine the extent of integration of strategic planning and continuous improvement in the select pharmaceutical companies in India.

The results of the study indicate that pharmaceutical companies in India still rely greatly on traditional planning methods for strategic planning. However, a shift is also observed toward adoption of best practice management and modern strategic management techniques. The study also demonstrates that continuous improvement goals and strategies are included into the corporate strategic planning.

The study employs only descriptive statistics, and no hypotheses are generated in the study because the objective is not to generalize the findings. The process of formulating quality goals and integrating them with strategy is typical to any company. Therefore, the findings cannot be generalized. The findings of the study do not given any insights into the strategic quality management process due to online mode of data collection. Also, the focus on the study is on the internal management of quality in an organization and factors in the external environment or in the value chain outside the firm, influencing strategic management of quality are beyond the scope of present study.

Considering the significance of quality of products, an understanding of the link between quality and strategic goals helps the managers in pharmaceutical industry to align the strategic planning goals with quality goals ensuring that the entire organization moves in same strategic direction.

The strong focus quality in pharmaceutical industry in India has given impetus to development of well-managed quality programs on the shop-floor to remain competitive and survive in the highly competitive global markets. However, no such study is conducted so far to understand the extent to which continuous improvement or TQM practices are integrated into strategic planning in the pharmaceutical companies in India.

The purpose of this paper is to assess the quality of Tehran pharmacies' services and their impacts on the pharmaceutical firms, to highlight forces behind the current situation and suggest some improvements. This provides the means for pharmaceutical companies to differentiate themselves by quality of services, in the forefront of dealing with the customers, so‐called the last “touch point”.

After a comprehensive literature review, SERVQUAL model was chosen to be used in this study. A combination of quantitative and qualitative (integrative) methods was used for data collection and analysis. The quantitative data were gathered by questionnaires, including 22 pair items measuring expectation and perception, followed by qualitative data, including 32 in‐depth interviews. Furthermore, the views of our expert panel consisting of nine experts have been identical to the study. For statistical treatment of quantitative data, SPSS software was used.

The study reveals that Tehran community pharmacies are facing serious service quality problems. The results of quantitative data show negative gaps in perceptions and expectations of customers in all 22 SERQUAL statements and all dimensions: Information, Reliability, Empathy, Appearance and Time commitment. Comparatively, appearance dimension is ranked as the highest quality and the lowest rank belongs to information dimension. The findings show that the generic SERVQUAL scale does not properly measure the quality of pharmacies' services; therefore, the authors recommend an industry‐based scale; called PHARMA‐SERVQUAL. The findings show the reasons for low quality services are: low education of pharmacists' assistants, lack of proper regulation and control, pharmacies' economic problems and cost of quality improvement, the culture of blaming others and accusing pharmaceutical firms, government and social security organization. In short, pharmacists transfer their service problems to pharmaceutical firms, which have largely neglected this last touch point with the customer. The study also suggests some quality improvements and academic as well as managerial implications.

The study provides empirical evidence regarding the service quality of pharmacies in a developing country (Iran) and adds depth to the understanding of the reasons behind the quality problems. This research contributes to the understanding of how pharmacies' qualities of services enhance/change the customers' perception of the pharmaceutical companies' product qualities. It suggests that the firms should differentiate themselves at the pharmacies as the “last touch point” dealing with the end‐users. The study sheds light on the necessity of modifying the SERVQUAL items and dimensions to fit pharmacies' services.

This paper examines the relationship between the originality of a pharmaceutical innovation and its patent quality. Greater patent quality has been shown in the extant literature to enhance market value, which better enables firms to recoup research and development (R&D) expenditures incurred during the innovation process. Understanding how originality improves patent quality can assist policymakers, when determining the optimal length of pharmaceutical patent protection and/or market exclusivity.

The relationship between originality and patent quality is empirically investigated using a tobit, as well as a zero-inflated negative binomial, estimation approach to account for prevalence of patents receiving zero forward citations. Moderating effects of joint innovation, innovation by a university researcher and innovation by an established innovator on originality are also considered.

There is a robust and positive relationship between patent originality and quality in the pharmaceutical sector. This relationship is positively moderated by joint patent ownership with a university. As such, innovators that target originality in new drug development (especially those collaborating with universities) should, according to extant literature, see greater increases in their market value.

Policymakers can use information on the originality of a new drug to discern the optimal length of market exclusivity needed to enable the innovator to recoup expenditures related to R&D. Better predictions of the timing for which firms can recoup R&D expenditures will equip policymakers with knowledge about the appropriate timing to introduce competition into the market, which is critical to reducing the price of pharmaceuticals to consumers.

Pharmaceuticals supply chain management (SCM) requires special expertise to transport the medicinal products because of weird features of their demand, supply and sensitivity towards quality. The purpose of this study is to establish the linkage of pharmaceutical quality system requirements with the SCM principles. The study enables the collaborative approach of technical, transport, logistics and supply chain teams within the pharmaceutical industry.

The methodology followed for this study is literature review and survey. The study is supplemented with data obtained through the structured questionnaire.

Through this study, an exclusive perspective for pharmaceutical good transportation practice (GTP) has been propagated in alignment with seven principles of SCM by Anderson. This study offers guidance to pharmaceutical industry for transportation of products by conceptualizing basic supply chain features such as segmentation, customization of requirement, market signals, differentiation, technology orientation and channel spanning performance.

Here is limited information available about the transportation failures in the pharmaceutical industry. Application of supply chain principles to pharmaceutical transportation is sometimes affected by technical knowledge bias of the researcher.

The study has successfully expounded the practical aspects of pharmaceutical GTP for supply chain professionals.

The study facilitates the patients and pharmaceutical consumers to get quality products in a timely manner across the globe.

The application of SCM principles to the pharmaceutical GTP is the result of novel research and has not been studied earlier.

The purpose of this paper is to develop a scale for the measurement of service quality at the manufacturer–doctor interface of the pharmaceutical supply chain and to study the impact of service quality on doctor’s satisfaction and doctor’s prescribing behavior. Doctors from two major states of South India were selected for the study. A doctor perceived service quality scale with three dimensions having eight items was developed through confirmatory factor analysis (CFA) in the pharmaceutical context. Structural equation modeling (SEM) technique was used to show the relationship between service quality, satisfaction and prescribing behavior. The critical factors of service quality were identified, and a model was developed showing the relationship between service quality, doctor’s satisfaction and doctor’s prescribing behavior which has not been explored in any research. This model will be helpful in further development of new concepts and for analyzing the reasons for the failure of doctors in providing quality service. 

A total of 200 doctors from three major cities of South India were selected. A doctor perceived service quality scale with three dimensions having eight items was developed through CFA using Parasuraman Service quality scale (Parasuraman, 1985, 1986, 1988) as the basis in the pharmaceutical context after focus group discussions with company experts, retailers, doctors and academicians. SEM technique was used to examine the impact of service quality on doctor’s satisfaction and prescribing behavior.

There is no universal set of dimensions and items that determine service quality in manufacturing industries, especially at the manufacturer–doctor interface of the pharmaceutical supply chain though service quality plays a very important role in affecting the performance of manufacturing industries. The critical factors affecting the quality of service for a pharmaceutical company at the manufacturer–doctor interface of the supply chain were identified, and its impact on doctor’s satisfaction and their prescribing behavior were studied.

This research contributes to the development of service quality scale for measuring service quality in pharmaceutical manufacturing company, especially with reference to manufacturer–doctor interface of the supply chain which was not thoroughly explored earlier. A model was developed showing the positive relationship between service quality and doctor’s satisfaction and doctor’s prescribing behavior in pharmaceutical supply chain which is a new concept not proved experimentally.

The study is very useful for the pharmaceutical manufacturing companies to identify the service quality factors affecting doctor’s satisfaction and their prescribing behavior thereby leading to development of new measures for improving the performance of the pharmaceutical supply chain. This study can lead to identification of problems involved in pharmaceutical supply chain and also leads to generation of new ideas and development of new concepts for influencing doctor’s satisfaction and doctor’s prescribing behavior which in turn can help in providing better health.

This study actually has a direct impact on the society. If factors affecting doctor’s satisfaction and prescribing behavior are identified automatically, the end consumer, i.e. patient, can be satisfied in a better way, and better medical care can be provided. If doctor’s problems are identified, then better solutions can be provided to patients; this in turn has a lot of positive impact on the pharmaceutical company and society in general.

This research will act as a base for generating ideas relating to how quality service provided by a company will have an impact on doctor’s satisfaction and his prescribing behavior in pharmaceutical supply chain .To the best of the authors’ knowledge, this study is the first of its kind of the conceptual aspects of service quality, satisfaction and loyalty explained in terms of pharmaceutical supply chain as service quality, doctor’s satisfaction and doctor’s prescribing behavior and proved experimentally.

This research aimed to investigate the information-seeking behaviour (ISB) and information needs of different professional groups within the pharmaceutical manufacturing sector in the Republic of Ireland (i.e. for what purpose information is acquired), the information sources professional groups use (including in-house documentation, regulations, industry guidelines, standards and colleagues) and the factors, which influence professional groups' choice of information sources. Furthermore, the research explored the perceived level of support that exists towards knowledge and information sharing.

A quantitative non-experimental research design, comprising of a self-completion survey questionnaire, was used to examine a number of information-seeking variables: information triggers, information sources and source influencers as well as information sharing enablers. It was related to four professional tasks: process technology/process development, regulatory support and quality/compliance support and engineering.

The research provides new insights into the ISB of pharmaceutical professionals working within a highly regulated and high-performance production environment, including a greater understanding of the context in which professional groups experience information needs. The levels of agreement observed in relation to employees' perception of information-sharing enablers indicated an overall positive level of information sharing.

The study points to largely echoed previous findings which suggest that individual work role associated tasks prompt particular information needs. Further to this, work role associated tasks have a bearing on information source selection. Pharmaceutical professionals engaged in positive levels of information and knowledge sharing, relying on procedures, other colleagues and internal documentation as information sources. The participants also indicated a high level of agreement in respect to the value of available subject matter experts as information-sharing enablers.

Organisations should aim to create opportunities for adequate time to share information and organisational structures, facilitating an overall organisational culture of sharing. A focus on information sharing through forums, seminars, meetings and working groups could enhance information sharing, through the development of communities of practice.

Pharmaceutical professionals relied on trustworthiness and quality as professional' top information source-influencing factors. Furthermore, the study demonstrated that working within a high-performance, target-driven and time-constrained production environment brings a particular contextual impact, where frequent urgent information triggers are experienced. These contextual factors warrant further investigation.

A paucity of information exists with respect to the ISB of professionals, working within the pharmaceutical manufacturing sector, which is a sector known for its high level of information use and production. This paper offered an original empirical investigation of the ISB of professionals, working within the pharmaceutical manufacturing sector in the Republic of Ireland, focussing on key professional tasks. The research also addressed the level of support available for knowledge and information sharing.

The purpose of this paper is to assess the quality practices of European pharmaceutical manufacturers to determine the level of readiness of this industrial sector to implement and/or sustain lean manufacturing (LM).

An assessment framework developed by Al-Najem et al. (2013) was adapted to evaluate how ready European pharmaceutical manufacturers are to implement and/or sustain LM. Therefore, the lean readiness (LR) level of these organisations was assessed through six quality practices related to LM. These included: processes, planning and control, human resources, top management and leadership, customer relations, and supplier relations. One research question and three hypotheses were formulated and tested using a combination of descriptive statistics and non-parametric Mann-Whitney tests. Data were collected through a survey questionnaire distributed to 310 European pharmaceutical manufacturers and responded by 37 of these organisations.

Overall, the results of this study indicate an inadequate level of LR for the participating firms. Simultaneously, it was concluded that factors such as company size, type of relationships with suppliers and ISO 9000 certification do not have an effect on the quality practices, and hence LR level, of European pharmaceutical manufacturing organisations.

This study provides crucial information regarding the LR level of European pharmaceutical manufacturers, which can now be aware of the areas in their practices that require further improvement towards a successful lean journey. Simultaneously, organisations in the pharmaceutical sector that intend to implement LM can consider the results of this study and evaluate their readiness level. Managers can, therefore, refer to this research and use it as a platform to take better decisions regarding what quality aspects of their operations need to be enhanced to successfully deploy or sustain a lean strategy.

This research is one of the very few studies that have focussed on evaluating whether the European pharmaceutical manufacturing industry is ready to successfully implement or sustain LM. Therefore, this research expands the limited existent body of knowledge of LM in this industry.

The purpose of this article is to demonstrate the application of the tools and techniques of Quality by Design (QbD) approach in an Indian pharmaceutical drug product manufacturing company and to understand the challenges, managerial implications and lessons learned while implementing this initiative.

This work adopts the Action Research methodology for impurity reduction in a drug product manufacturing company in India by using the tools and techniques of QbD approach. Various QbD tools like Design of experiments, process capability evaluation and control charts were effectively utilized for the study.

As a part of QbD implementation in the organization, a specific drug product was identified and the impurity level in the product was studied. Significant variables impacting the impurity were identified and the optimum levels for the significant variables were identified through design of experiments. The solutions were implemented and the impurity levels were reduced significantly.

Even though the article is based on a single case study related to tools and techniques of QbD in a single organization in India, the identified problem is a generic product quality related issue for any pharmaceutical drug product manufacturing company. Hence the findings of this research are applicable to pharmaceutical drug manufacturing industry in general.

This article illustrates the systematic usage of various tools and techniques of QbD methodology in a pharmaceutical drug product manufacturing company. The usage of Design of Experiments for process optimization and application of other tools and techniques are ready references for the practitioners and novice users in the field.

Empirical studies on the supply chain quality management (SCQM) of the pharmaceutical sector are scarce and scattered. This paper investigates a set of key quality determinants in the pharmaceutical sector to offer a holistic quality control framework for its supply chain (SC).

A mixed-method design was used. A focused group discussion with seven pharmaceutical SC managers summarized the narratives of the SCQM in this sector and helped to develop a questionnaire. The survey data were collected from the managers of 299 pharmaceutical firms.

The statistical results show the key determinants are leadership (LS), customer focus (CF), process integration and management (PIM), supplier relations (SR), quality practice (QP), human resource practices (HRP) and safety (SF). Unlike many other sectors, in the pharmaceutical SC, logistics and inventory costs have been proved to be not as important as other measures in the eyes of the SC managers and as part of SCQM performance measures, which can be a result of the priority systems influenced by the World Health Organization standards.

The study is distinctive in its scope as is carried out in a developing country with focus on concept of SCQM with reference to pharmaceutical SC. It shows great potential for further studies and improvements in logistics and warehousing in this sector, for the interest of the pharmaceutical SC managers and regulators who aim to ensure safety and quality in the health-care sector.