Pharmaceutical Manufacturing Industry Research Articles

Crystal-size distribution-based dynamic process modelling, optimization, and scaling for seeded batch cooling crystallization of Active Pharmaceutical Ingredients (API)

Crystallization of active pharmaceutical ingredients (API) is one of the most important and complex multiphase engineering operations in pharmaceutical manufacturing industry. The desired physicochemical properties of solid crystalline product, such as crystal size distribution (CSD), are achieved by optimizing appropriate analyzed process operating conditions. In this application-derived study, an efficient straightforward mathematical modelling approach for the d value targeted CSD (characterized by 10th, 50th, and 90th centiles d10, d50, and d90) optimization of the API fesoterodine fumarate (FF) batches in different solvent mixtures on reactor dimension scales from 0.1 to 15 L is presented. The model is based on energy, mass, and population balance equations, the thermodynamic system equilibrium between solute/solution, and the kinetics of nucleation, crystal growth, and crystal agglomeration. In the first set of two experiments, the ability of the model to predict final CSD under chosen operating conditions was validated applying particular previously estimated kinetic parameters. An excellent statistical agreement between predicted and experimental CSD results was observed. Furthermore, the utility of the model to determine suitable operating conditions for the formation of FF crystals with d value defined CSD is presented. Two additional experiments were designed where stirring, cooling rate, and the amount of seed were optimally regressed. Good agreement between targeted and experimental CSD was shown and depending on the chosen vessel unit, mixing & cooling rates had the strongest relative impact on CSD. Algorithm may be beneficially utilized early during API industrial technological development, intensification, and scale-up, or transferred to continuous flow.

Heterogeneous Stock Market Reactions to COVID-19: More Hidden Mechanisms

This paper studies the heterogeneous effects of the COVID-19 outbreak on stock prices in China and its hidden mechanisms from multi perspectives. First, we confirm the recent conclusion that the spread of the epidemic has a significant negative impact on stock market returns. However, this effect is heterogeneous for different industries. In particular, stocks not only in the pharmaceutical manufacturing industry but also in its upstream industry, the chemical industry, even benefit from the epidemic. Second, we construct a fear sentiment index by using data from searching volume of COVID-19 related words and find that the fear sentiment can directly cause the stock price to fall. Moreover, the panic will exacerbate the negative impact of the epidemic on stock returns. Third, and most importantly, we demonstrate the underlying mechanisms from four firm characteristics. The results show that companies with high asset intensity, low labor intensity, high inventory-to-revenues ratio, and small market value are more negatively affected. We argue that the labor employment in state-owned enterprises is less flexible, so for labor-intensive state-owned firms, their stock performance worsens because of higher idle labor costs. Our evidence also strongly supports this hypothesis. Finally, we create a brand new index based on the WIOD input-output database to measure the relative position of an industry in the supply chain. Our findings show that companies located downstream are more vulnerable to the COVID-19 outbreak.

The Significance of Quality Metrics in a Pharmaceutical Quality Management System – A Case Based Study

Abstract: Background: The pharmaceutical quality management system is a concept of management function that design and implement the “Quality policy”. The pharmaceutical manufacturing industries all over the world have just begun to apply the United States Food and Drug Administration (USFDA) guidelines in the 21st century. The study tries to identify the quality metrics based on Quality Indicators for a pharmaceutical industry and to investigate the utilization of quality KPIs. Methodology: The work experience from a successfully working pharmaceutical organization related to Research and and Development (R&D) of pharmaceutical products are discussed here. Important areas were identified and analysed based on the data collected from the deviation reports of selected organization and other resources. The R&D centre uses a software system for Quality management system including, Deviation management, Change management, Laboratory investigation, Incident management and Corrective Action and Preventive Action (CAPA). Results: The primarily considered Quality indicator (QI) was the pharmaceutical deviation. A Among the deviations reported in the year of 2017-18, 214 cases were selected as sample. In this 171 were permanent deviations and 43 is temporary deviations. Secondarily, Pharmaceutical incidents are selected for the study as the QI in which 70% of the root cause is due to human related issues. Failure to meet acceptance criteria comes first with 48% and failure to follow procedure with 28%. Conclusion: A good quality metrics system supports both industries’ profitability, GMP compliance and precludes overproduction of metrics; only measure what adds value to quality in the most efficient way. Key words: Quality Metrics, CAPA, Key performance indicators, Deviation, Change control.

Covid 19 – Impact and new normal for pharmaceutical industry (Part – I)

This review article shares New Normal as part of impact of Covid 19, on Pharmaceutical Industry globally as whole & Manufacturing Operations as preventive measures or cure of Covid 19. Based on known transmissions & spreading routes, the Pharmaceutical Industry Manufacturing Operations needs to learn to avoid such impacts of transmissions & spreads. The pharmaceutical and healthcare operations need to take care to protect personnel As such The Pharmaceutical Industry does take very good care to avoid cross contaminations as part of Good Manufacturing Practices (GMP). But now keeping in mind seriousness of virus spread, the Pharmaceutical Industry has to take precautions to avoid transmission & spread during travel in buses, entry & exit procedures, change rooms, avoid hand touch to doors, handles etc. at office work places & throughout the manufacturing operations at site This article looks at various stages the Pharmaceutical Manufacturing Operation sites has to take care depending types of products & human involvement in such operations As per WHO, key major steps to protect against the infection are: • Social distancing • Use of Masks/Face- Shields • Frequent Washing of Hands with soap & water or Sanitisation with proper sanitisers containing min. 70% Alcohol. • Segregation of staff in essential & non-essential at manufacturing site. • Non-essential staff to work from home Essential staff are the ones who are required to work in person at manufacturing site The Pharmaceutical Industry is moving forward very confidently by amending concerned SOP’s to meet Covid – 19 impact & challenges. This article describes “New Normal – impacts” of Covid-19 & basic requirements like Personal hygiene, Entry/Exit procedures to Protect the Workplace & Safety of the Workforce.

Harmonic Amplitude Dispersion: When Production Intrinsic Prior Meets Oxygen Concentration Detection of Pharmaceutical Glass Vials

In situ and accurate oxygen concentration detection is drawing great attention in the pharmaceutical manufacturing industry. This article proposes a novel concept of harmonic amplitude dispersion (HAD) under the framework of wavelength-modulation-based tunable diode laser absorption spectroscopy (TDLAS/WMS). Then, a reliable production intrinsic prior to the long-term information entropy distribution pattern is learned from the demodulated second-harmonic signals. Interestingly, the performance in oxygen concentration detection can be improved in two rounds by the HAD concept. First, for accuracy, signal reconstruction is implicitly carried out during the HAD-based parameter optimization process for the horizontal span ( $k_{x}$ ) and the vertical tension ( $k_{y}$ ) in the Voigt spectral line modeling. This method is denoted as HAD signal reconstruction (HADSR). Second, for efficiency, with the guidance of HAD, only approximately 12% of reconstructed signals are fed into the online sequential extreme learning machine (OS-ELM) for further concentration classification, as the data with higher HADs are determined to be uninformative and are discarded early before data training to enable the classifier to be more compact. The detection framework of HADSR + OS-ELM was first verified on an automated vision inspection machine in an actual pharmaceutical manufacturing line. Promisingly, the proposed HAD robustly narrowed the average variance in the signal peak-to-peak values by nearly 30%, and together with the HAD-guided OS-ELM, an average detection accuracy of 98.1% within an acceptable time cost of 300 ms/vial was realized during a long-term test.

Evaluation of energy-saving potential for optimal time response of HVAC control system in smart buildings

In some fields, such as the semiconductor manufacturing process, museum, pharmaceutical, and medicine manufacturing industry, the HVAC system needs a very fast response time to protect products and more energy-efficient buildings than traditional controllers. So, the proposed controller is designed to overcome such problems by using integrated fuzzy PI-PD Mamdani-type (FPIPDM) and cluster adaptive training based on Takagi-Sugeno-Kang (CABTSK) type. The spans of the fuzzy membership functions of the FPIPDM are tuned online by the Nelder-Mead simplex search (NMSS) algorithm to minimize time response, while the CABTSK model is tuned offline and online using a gradient descent (GD) algorithm to enhance the stability of the overall system and reject disturbances. Then, the integration framework is used to enable the concept of time-optimal based on the bang-bang code delegation. In this sense, a selected switch delegates the execution of proper control code to the action processor that provides computational resources to control indoor conditions. The predicted mean vote (PMV) index provides a higher comfort level than the temperature, as it considers six variables related to thermal comfort. The results of the proposed structure show that it improves the overall output accuracy and significantly reduces the response time. Furthermore, it increases the robustness of the indoor conditions and it is quite applicable to the MIMO HVAC systems processes with strong coupling actions between temperature and humidity, large time delay, noise, disturbances, nonlinearities, and imprecise identification model.

Regional technology gap and innovation efficiency trap in Chinese pharmaceutical manufacturing industry.

ObjectiveThere is a huge technology gap between regions in Chinese pharmaceutical manufacturing industry, which is the reality that must be faced. However, most of the available researches on innovation efficiency are based on the logic of a given technology level, ignoring the regional technological gap. This paper will stand from the perspective of technology gap and re-examine the innovation efficiency of pharmaceutical manufacturing industry in different regions of China and its impact on regional industrial competitiveness.MethodsWe use the DEA-BCC input-oriented model to measure innovation efficiency of 28 provinces from the data of China's pharmaceutical manufacturing industry. The threshold model is constructed, with technology level as the threshold variable, innovation efficiency as the main explanatory variable, and industrial competitiveness as the dependent variable. In the threshold model, 28 regions are divided into three technical groups, and further, the impact of innovation efficiency on industrial competitiveness in different groups is analyzed and compared.ResultsAccording to the empirical research results, an U-shaped efficiency trap has been found in Chinese pharmaceutical manufacturing industry, and the areas with medium technical level are at the bottom of the trap. The improvement of innovation efficiency does not necessarily promote the improvement of regional industrial competitiveness. Only in high-level and low-level technology groups, innovation efficiency has effectively promoted the improvement of industrial competitiveness. In addition, the intensity of R&D investment has a similar impact on industrial competitiveness.ConclusionsThe findings suggest that, regions in the efficiency trap should strive to seek opportunities for industrial transformation and focus on the industrial transformation of new technology, new industry and new opportunities, instead of blindly pursuing R&D investment intensity and superstitious innovation efficiency. So as to free up innovation resources for high-quality technological innovation in other regions. In addition, the Chinese government should make use of its public hospital system to normalize and expand the centralized drug procurement and eliminate the low-quality innovation.

Physico-chemical Properties of Starches from Two Varieties of Sweet Potato and Yam Tubers Available in Nigeria

The research sought to investigate the functional properties of starches obtained from four Nigerian root and tubers, yam and sweet potato varieties, in order to facilitate their exploitation as substitute raw material for the local food and pharmaceutical manufacturing industry. The varieties, namely: white yam (Dioscorea rotundata), water yam (Dioscorea alorta), orange flesh sweet potato (Ipomoea batatas) and cream flesh sweet potato (Ipomoea batatas), their respective starches were obtained by wet separation techniques and were analyzed for their pasting properties, physic-chemical properties, starch yield on dry and wet basis, functional, starch purity, amylase and amylo-pectin were undertaken in order to determine their suitability for food and other uses. The peak time, pasting temperature, peak viscosity, holding strength, breakdown, set from peak and set back from through ranged from 7.3 – 8.3 mins, 65.4 – 71.3°C, 511.5 – 1001.2 BU, 860.8 – 871.3 BU, 300.1 – 306.9 BU, 240.8 – 248.1 BU and 400.4 – 510.9 BU respectively. There were significant differences (p<0.05) in the pasting properties. The crude protein, crude fat, crude fibre, ash, moisture and carbohydrate ranged from 1.55 – 1.85%, 0.09 – 0.12%, 0.12 – 0.22%, 1.32 – 2.05%, 10.72 – 11.09% and 85.59 – 86.20% respectively. There were significant differences (p<0.05) in the proximate composition of the starches. The starch yield on dry weight basis, starch weight on fresh weight basis, starch yield from tubers and percentage dry matter ranged from 56.84 – 85.88%, 22.75 – 36.07%, 18.02 – 26.00% and 40.02 – 44.01% respectively. There were significant differences (p<0.05) in the all the parameters. The bulk density, water absorption capacity, oil absorption capacity, gelatinization temperature, starch purity, amylase, amylo-pectin and pH ranged from 0.56 – 0.61g/cm3, 86.8 – 99.4%, 103.2 – 125.4%, 59.78 – 60.42°C, 95.28 – 96.55%, 27.25 – 29.37%, 70.63 – 72.63% and 6.82 – 6.91 respectively. There were significant differences (p<0.05) in all the parameters but no significant difference (p>0.05) in the pH. The starches from yam and sweet potato varieties starches can be exploited for diverse uses based on their different characteristics.

Source identification, spatial distribution pattern, risk assessment and influencing factors for soil heavy metal pollution in a high-tech industrial development zone in Central China

We determined the spatial distribution pattern, source, risk level and influencing factor of heavy metal pollution in a typical high-tech industrial development zone of Changsha, China. A total of 123 topsoil samples were excavated from 11 different land-uses. Quite strong pollution (Nemerow) occurred in the whole zone. The Igeo pollution levels were from slight to strong for these elements. Four primary components were extracted from PCA with 79.36% of total variance explained. It could be deduced from the primary components that Cu, Co, Ni normally resulted from electronic industry; As and Cr were affected by both industrial and natural source; Pb and Zn were originated from traffic activities; and Cd was correlated with the activities of General equipment manufacturing industry and pharmaceutical manufacturing industry. The concentrations of Pb and Zn decreased from densely populated areas to suburbs, while the high concentrations of the other six elements were mainly found in the industrial lands. Heavy metal concentration was in weak relationship with green cover ratio (GCR) and built time, inferring that increase of GCR might not be contributed to improvement of the heavy metal pollution. While a reasonable spatial planning of land use had positive effects on controlling heavy metal pollution.

Re-Innovation from Failure, Institutional Environmental Differences, and Firm Performance: Evidence from China

Due to an anti-failure bias, theoretical and practical studies have not focused much on the problem of innovation failure. The literature does not include studies on how the effect of re-innovation input on firm performance can still be explained by existing theories, especially in the case of previous innovation failures. To explore the intrinsic relationship between the re-innovation from failure and firm performance, as well as the influencing mechanism of the institutional environment differences on a firm’s re-innovation activities, using the data of the Listed Companies in China’s pharmaceutical manufacturing industry from 2008 to 2014 and a multiple regression model, the relationships between the re-innovation from failure, institutional environment differences, and firm performance were analyzed from 3 aspects: government intervention, financial development, and legal environment. The results show that the re-innovation input from failure has a significant positive impact on firm performance. The level of government intervention and the level of financial development play significant negative and positive moderating roles in the relationship between the re-innovation input and firm performance, respectively, and the above-mentioned effects are more prominent in eastern China. Moreover, with the improvement of the marketization of the financial industry, the beneficial effect of the re-innovation input from failure on firm performance in state-owned firms will be further strengthened. However, the moderating effect of the legal environment is not obvious.

Leveraging Integrated Continuous Manufacturing to Address Critical Issues in the U.S. Military

There is a tremendous opportunity to modernize the pharmaceutical manufacturing industry-relinquishing outdated machines that have been used for decades, and replacing them with state-of-the-art equipment that reflect more contemporary advanced technologies. This article describes how the implementation of continuous manufacturing, replacing outdated batch systems, can positively impact our health care sector. Important benefits will include the creation of advanced pharmaceutical manufacturing jobs in the United States, the establishment of capabilities and capacity to quickly produce drugs critical to U.S. citizens, the reduction of health care costs through more efficient manufacturing, and access to better quality drugs through more sophisticated and reliable production processes. Furthermore, the application of continuous manufacturing will enable the U.S. Government, in partnership with pharmaceutical companies, to address current issues such as drug shortages, national emergencies (eg, natural disasters or chemical, biological, radiological, or nuclear threats), the Strategic National Stockpile (ie, improving response time and reducing maintenance costs), and the delivery of critical drugs to distant geographies (eg, forward military bases). The article also provides a detailed example of a critical aspect of continuous manufacturing: the ability to overcome technical challenges encountered by batch technologies.

Industrial Policy Response to the Covid 19 Crisis in Ireland – A Filière Approach

The economic shock represented by the Covid19 crisis has been showing the limits of industrial policy choices such as that of the chosen globalisation model, a model characterised in particular by the relocation of “key” manufacturing activities away from EU countries and towards low-cost emerging countries. In relation to the Covid19 crisis, relocation emanates from industrial policy choices that have weakened the health filière (encompassing the chemicals & pharmaceutical manufacturing industries and the health service industry). The specific case of Ireland shows a strong manufacturing specialisation in the relatively resilient pharmaceutical industry, a strength undermined by a relatively inefficient health service industry. National policy responses have taken the form of a large number of schemes estimated to amount to some €5bn. Questions arise in terms of the ability of the EU, and of Ireland therein, to secure its health sovereignty in the future, and in terms of the implications of growing indebtedness, particularly in the euro-area.

An Exploration of Contemporary Issues of Supply Chain Management: A Case on Pharmaceuticals Manufacturing Industry in Sri Lanka

Supply Chain Management (SCM) has a crucial role in facilitating the production, marketing, logistics and purchasing processes of an organization since it may focus on the management’s attempts to maintain or build competitiveness in changing environment. This study was carried out as qualitative cross-sectional multiple case studies using semi-structured interviews to collect data. Case studies were chosen on the judgmental non-probability sampling method to explore contemporary issues and the reasons for SCM in the pharmaceutical manufacturing industry of Sri Lanka. It further tried to recommend solutions to mitigate those issues to increase the effectiveness of the pharmaceutical supply chains. Interviews were conducted with the employees who are responsible for SCM from each case study. A thematic analysis was carried out to achieve the purpose of the study using Nvivo 12. Unpredictable lead time, no proper guideline or standards in custom for pharmaceutical product regulations, lack of temperature control in warehouses at custom, underutilization of human resources consuming, delaying duty waiver and other regulatory approval from the National Medicines Regulatory Authority (NMRA), frequent changes of the NMRA guidelines without any grace period, technical knowledge gap of employees for R&D, and challenge from generic competitor products from other countries were identified as the major drawbacks in SCM process of pharmaceutical supply chains in Sri Lanka. Further, failure to identify correct raw materials suppliers, issue of Minimum Order Quantity (MOQ), buffer stock maintenance issues, no proper reverse logistics management procedures, shortage of approved vehicles for transportation, finding of trustworthy local packing materials suppliers, forecasting errors, and communication gap or language barrier of employees also slower the effectiveness of supply chains.

Knowledge Management Infrastructural Capabilities as Antecedents of Innovation: A Structural and Mediation Analysis

This study develops and empirically tests a KM infrastructural capabilities-based model of innovation, which integrates technological and organisational design capabilities, in addition to the KM process capability of knowledge integration. It does so through investigating the effects of knowledge management technological infrastructural (KMTI) capability, in addition to the 'organic organisational design' (OOD) capability and 'knowledge integration' (KI), on innovation. A survey dataset of 203 questionnaires collected from the pharmaceutical manufacturing industry in Jordan was used. Structural equation modelling as well as mediated regression analyses revealed that KMTI positively and significantly affects each of OOD, KI and innovation. Each of OOD and KI positively and significantly affects innovation. Also, OOD and KI partially mediate the relationship between KMTI and innovation. As such, perspectives on information technology management, organisational design and innovation management have to be combined to understand how organisational innovation can be enhanced by using KM-related technological capabilities.

Enhancing Performance through Total Quality Management in Pharmaceutical Manufacturing Industry of Pakistan

The study is focused on the evaluation of total quality management (TQM) in the pharmaceutical companies of Pakistan and the effect that it produces. After thorough literature review, seven hypotheses were postulated comprising of nine variables encompassing TQM elements. A survey-based quantitative approach was utilised in which primary data was collected through self-administered questionnaires. Out of 350 questionnaires circulated, 301 responses were received that were used for the data analysis. The collected data was analysed using PLS-SEM and results were statistically evaluated. The investigation concluded that quality culture creates a chain effect that greatly improves performance of a company. It was also concluded that the proposed hypotheses are positively supported and that the implementation of TQM elements bring about positive changes in the overall performance of the pharmaceutical industry of Pakistan.

Double-Color Lanthanide Metal-Organic Framework Based Logic Device and Visual Ratiometric Fluorescence Water Microsensor for Solid Pharmaceuticals.

Water is one of the most widespread impurities and contaminants for pharmaceuticals and chemical products. A simple, fast and reliable water assay method is of high significance for the pharmaceutical and chemical manufacturing industries. In this work, lanthanide metal-organic framework Eu-dipicolinic acid/2-aminophthalic acid (Eu-DPA/PTA-NH2) was prepared as a double-color ratiometric fluorescent water sensor, which shows ultrasensitive (limit of detection 0.01% v/v) and linear broad-range (0-100% v/v) response to water. An innovative analytical device based on a one-to-two logic gate was constructed by using the water content and the two fluorescence responses as the input and output signals, respectively. The direct analysis of water content can be achieved by the four output types, NOT (0, 1), PASS 0 (0, 0), PASS 1 (1, 1), and YES (1, 0). Importantly, the metal-organic framework (MOF)-loaded fiber paper was prepared as a microsensor, and a water assay tube was designed for rapid water detection of solid pharmaceuticals via ratiometric chromaticity, coupled with a portable visual determination device. The paper-based microsensor is response-rapid (20 s), long-term stable (at least 30 days), and can achieve the accurate (relative error <9.8%) visual assay of trace water in solid pharmaceuticals. To our knowledge, this is the first time to report an MOF-based double-color ratiometric fluorescent water sensor, a water analytical logic device, and a paper-based water microsensor for point-of-care visual water assay in solid samples via ratiometric chromaticity.

Techno-economical evaluation of coupling ionizing radiation and biological treatment process for the remediation of real pharmaceutical wastewater

Abstract Pharmaceutical manufacturing industries produce a vast range of substances by using organic and inorganic compounds as raw material thereby gives rise to huge volume of toxic and complex organic liquid effluents comprised of high levels of dissolved solids. High and low strength wastewater streams originating from manufacturing unit often contains different types of contaminants, including organic compounds which can be difficult to treat with conventional methods of treatment. In this study, the sequential treatment process of coagulation, electron beam (E-beam) irradiation and biological treatment was employed on real pharmaceutical industrial wastewater to study the impact of combined treatment on remediation and detoxification of the wastewater. Combined treatment was performed on low (LOSW) and high (HOSW) organic strength wastewater collected from representative pharmaceutical industry. Operational parameters like pH, absorbed dose and use of oxidants were systematically investigated to achieve the enhanced treatment of wastewater streams using E-beam irradiation. Biological treatment was carried out using activated sludge process at laboratory-scale reactor by utilizing acclimatized consortia in the experiments. Sequential hybrid coagulation, E-beam irradiation and biological treatment lead to synergistic degradation and detoxification of both the recalcitrant wastewater streams with overall chemical oxygen demand (COD) removal of 94% and 89% for LOSW and HOSW, respectively. Cytotoxicity assessment revealed that the combined treatment of wastewater was effective in eliminating the toxicity when tested against the selected microorganisms. The treatment cost of E-beam radiolysis alone, biological treatment alone and E-beam + biological treatment for LOSW was found to be 0.50, 2.35 and 2.85 USD m−3; whereas, for HOSW, it was found to be 0.67, 0.7 and 1.37 USD m−3, respectively. The overall cost of the set-up of an E-beam unit and the treatment cost for real pharmaceutical wastewater was evaluated to establish the applicability of the E-beam technology at industrial scale. The feasibility of E-beam irradiation for wastewater remediation may ensure future smart cities with sustainable resource management.

Integrated continuous manufacturing in pharmaceutical industry: current evolutionary steps toward revolutionary future.

Continuous manufacturing (CM) has the potential to provide pharmaceutical products with better quality, improved yield and with reduced cost and time. Moreover, ease of scale-up, small manufacturing footprint and on-line/in-line monitoring and control of the process are other merits for CM. Regulating authorities are supporting the adoption of CM by pharmaceutical manufacturers through issuing proper guidelines. However, implementation of this technology in pharmaceutical industry is encountered by a number of challenges regarding the process development and quality assurance. This article provides a background on the implementation of CM in pharmaceutical industry, literature survey of the most recent state-of-the-art technologies and critically discussing the encountered challenges and its future prospective in pharmaceutical industry.

Assessment of Total Quality Management Adoption Level in Pharmaceutical Manufacturing Companies in Southwestern Nigeria

The objective of this study was to assess the adoption level of Total Quality Management (TQM) in pharmaceutical manufacturing industry in Southwestern Nigeria by a cross-sectional survey of staff in Lagos, Ogun and Oyo States of Nigeria involving 348 of the 2,649 members, selected by multi-stage sampling. Primary data were collected using a set of pre-tested semi-structured questionnaire which sought to elicit information on the level of TQM adoption and designed with items on a Likert–type scale of seven alternative responses with weighting scores of 0 through 6, representing seven stages (levels) in the adoption process. Adoption was taken as becoming effective from the sixth stage (level 5). Factors influencing TQM adoption were identified by employing a Likert-type influence scale with five alternative responses and weighting scores of 0 - 4. Weighted averages (WA) and means of weighted averages (MWA) were employed in summarising the data while t-test and regression analyses were used in identifying significant relationships between variables at 5% significance level. The results showed that TQM adoption was at implementation (trial) level (MWA ≈ 4) and had not become actualised in the industry (t = 11.906, df = 3, p = .000). The study concluded that the adoption level of TQM in this industry was at trial level and TQM adoption was ineffective. Thus, there is need for improved adoption of the various components of TQM, particularly ‘leadership commitment’ and this can be achieved through sustained TQM training and advocacy by professional associations within the industry such as Nigerian Association of Industrial Pharmacists (NAIP) and Pharmaceutical Society of Nigeria (PSN).

Measuring the innovation efficiency of the Chinese pharmaceutical industry based on a dynamic network DEA model

ABSTRACTA dynamic network data envelopment analysis (DEA) model is employed for measuring the innovation efficiency of the Chinese pharmaceutical industry. The results show that the reason for innovation inefficiency in the Chinese pharmaceutical manufacturing industry is the inefficiency of pure technology and scale, but pure technical inefficiency plays the main role. The contribution of knowledge innovation to innovation efficiency in the pharmaceutical industry is greater than that of commercialization.