Disparities versus Similarities: WHO GPPQCL and ISO/IEC 17025:2017 International Standards for Quality Management Systems in Pharmaceutical Laboratories

Medicines regulatory authorities expect pharmaceutical companies and contract research organizations to seek ways to certify that their laboratory control measurements are reliable. Establishing and maintaining laboratory quality standards are essential in ensuring the accuracy of test results. ‘ISO/IEC 17025:2017’ and ‘WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL)’ are two quality standards commonly employed in developing laboratory quality systems. A review was conducted on the two standards to elaborate on areas on convergence and divergence. The goal was to understand how differences in each standard's requirements may influence laboratories' choices as to which document is easier to adopt for quality systems. A qualitative review method compared similar items in the two standards while mapping out areas where there were specific differences in the requirements of the two documents. The review also provided a detailed description of the clauses and parts covering management and technical requirements in these laboratory standards. The review showed that both documents share requirements for over ten critical areas covering objectives, infrastructure, management systems, and laboratory processes. There were, however, differences in standard expectations where GPPQCL emphasizes system procedures for planning and future budgets that will ensure continuity. Conversely, ISO 17025 was more focused on the risk management approach to establish laboratory quality systems. Elements in the two documents form common standard requirements to assure the validity of laboratory test results that promote mutual recognition. The ISO standard currently has more global patronage than GPPQCL.

An Effort at Improving Reliability of Laboratory Data in Titrimetric Analysis for Zinc Sulphate Tablets Using Validated Spreadsheet Calculators

The requirement for maintaining data integrity in laboratory operations is critical for regulatory compliance. Automation of procedures reduces incidence of human errors. Quality control laboratories located in low-income economies may face some barriers in attempts to automate their processes. Since data from quality control tests on pharmaceutical products are used in making regulatory decisions, it is important that laboratory reports are accurate and reliable. Zinc Sulphate (ZnSO4) tablets is used in treatment of diarrhea in pediatric population, and as an adjunct therapy for COVID-19 regimen. Unfortunately, zinc content in these formulations is determined titrimetrically; a manual analytical procedure. The assay for ZnSO4 tablets involves time-consuming steps that contain mathematical formulae prone to calculation errors. To achieve consistency, save costs, and improve data integrity, validated spreadsheets were developed to simplify the two critical steps in the analysis of ZnSO4 tablets: standardization of 0.1M Sodium Edetate (EDTA) solution, and the complexometric titration assay procedure. The assay method in the United States Pharmacopoeia was used to create a process flow for ZnSO4 tablets. For each step in the process, different formulae were input into two spreadsheets to automate calculations. Further checks were created within the automated system to ensure validity of replicate analysis in titrimetric procedures. Validations were conducted using five data sets of manually computed assay results. The acceptance criteria set for the protocol were met. Significant p-values (p < 0.05, α = 0.05, at 95% Confidence Interval) were obtained from students’ t-test evaluation of the mean values for manual-calculated and spreadsheet results at all levels of the analysis flow. Right-first-time analysis and principles of data integrity were enhanced by use of the validated spreadsheet calculators in titrimetric evaluations of ZnSO4 tablets. Human errors were minimized in calculations when procedures were automated in quality control laboratories. The assay procedure for the formulation was achieved in a time-efficient manner with greater level of accuracy. This project is expected to promote cost savings for laboratory business models.

An Overview of Construction and Demolition Waste as Coarse Aggregate in Concrete

Fast development of the total populace and far and wide urbanization has surprisingly expanded the advancement of the construction industry. As a result of these activities, old structures are being demolished to make new buildings. Due to these large-scale demolitions, a huge amount of debris is generated all over the world, which results in a landfill. The use of construction and demolition waste as landfill causes groundwater contamination, which is hazardous. Using construction and demolition waste as aggregate can reduce the use of natural aggregates and the problem of mining. The objective of this study is to provide a detailed overview on how the construction and demolition waste material has been used as aggregate in structural concrete. In this study, the preparation, classification, and composition of construction and demolition wastes are also discussed.

The Alliance for Grassland Renewal: A Model for Teaching Endophyte Technology

To the author’s best knowledge, there are no published reports of effective methods for teaching fescue toxicosis and grass endophyte technology in the USA. To address this need, a group of university scientists, industry representatives, government agents, and livestock producers formed an organization called the Alliance for Grassland Renewal. One goal of the Alliance was to develop a teaching method that could be employed across all regions in the USA and all sectors of the agricultural community. The first step in developing this method was identification of experts who were familiar with the science and management of fescue toxicosis. The second step was curriculum development. Experts wrote a curriculum that addressed all aspects of toxicosis and management, including toxicology, animal nutrition, pasture management, economics, and mycology. The curriculum was created for presentation in lectures, laboratories, and in the field. The curriculum was in that it could be delivered across state lines, regardless of peculiar, in-state recommendations. The curriculum was also unique as it was unanimously supported by private companies otherwise in competition with each other. The final step in developing this teaching method was formulating a delivery plan. All experts, including university, industry, government, and production, volunteered to travel from any state in the USA, converge in one location, teach a 1-day workshop, then travel to the next location. The results of this teaching method indicate widespread success. Since 2012, experts across the entire USA have converged to teach Alliance workshops in Kansas, Oklahoma, Missouri, Kentucky, Georgia, South Carolina, North Carolina, and Virginia, with ongoing workshops in Arkansas and Tennessee. Data from post-workshop surveys indicate that instruction has been effective, as at least 50% of the participants stated their intention to adopt the endophyte technology presented in these workshops. The teaching method developed by the Alliance for Grassland Renewal has proved to be effective, and the Alliance continues to expand across the USA.

Impact of Management and Development of Destination Attributes on Coastal Tourists' Visitor Experience, Negombo, Sri Lanka

The purpose of this quantitative study is to identify the impact of the destination attributes of Negombo on the coastal tourists’ visitor experience. As an island nation, Sri Lanka is identified and well renowned for its gold sandy beaches and natural scenic beauty. Among many tourist attractions, Negombo is identified as a developed beach centric tourist destination in the country. Yet, it is identified that there are low positive reviews on the internet for Negombo compared to other beach centric tourist attractions in Sri Lanka. Therefore, this study would help the policymakers and tourism service providers to identify the impact of destination attributes on international visitor satisfaction and to understand the visitors comprehensively so as to develop Negombo as a stable tourist destination while offering a memorable and satisfying experience for its visitors. In support, a self-administered questionnaire survey study was performed with 150 respondents (international tourists) in Negombo. The questions were designed based on the selected dimensions of destination attributes such as tourism service quality, infrastructure and superstructure developments, tourist information facilities and destination aesthetics and developments. The results showed that the overall satisfaction level of the international tourists who visit Sri Lanka is significantly affected by the destination attributes of Negombo. Yet, the dimensions of destination aesthetics and developments and tourist information facilities indicated a low level of mean satisfaction, paving the critique that Negombo as a beach centric tourist attraction is not serving well with its natural beauty and its destination management. Further, it is advocated that the policymakers and tourism service providers have a significant role in leading the way to attract more potential visitors to enhance their destination satisfaction and to encourage them to revisit Sri Lanka while recommending it to others. The survey was done during the off-peak season of the industry and it is suggested that the survey would have been conducted throughout a complete year.

Cost Efficient Receiver Tube Technology for Eco-Friendly Concentrated Solar Thermal Applications

The world is in need of efficient energy conversion technologies which are affordable, accessible, and sustainable with eco-friendly nature. Solar energy is one of the cornerstones for the world’s economic growth because of its abundancy with zero carbon pollution. Among the various solar energy conversion technologies, solar thermal technology has attracted a substantial renewed interest due to its diversity and compatibility in various applications. Solar thermal systems employ concentrators, tracking systems and heat engines for electricity generation which lead to high cost and complexity in comparison with photovoltaics; however, it is compatible with distinct thermal energy storage capability and dispatchable electricity which creates a tremendous attraction. Apart from that, employing cost-effective solar selective receiver tube in a concentrating solar thermal (CST) system improves the energy conversion efficiency and directly reduces the cost of technology. In addition, the development of solar receiver tubes by low cost methods which can offer high optical properties and corrosion resistance in an open-air atmosphere would be beneficial for low and medium temperature applications. In this regard, our work opens up an approach which has the potential to achieve cost-effective energy conversion. We have developed a highly selective tandem absorber coating through a facile wet chemical route by a combination of chemical oxidation, sol-gel, and nanoparticle coating methods. The developed tandem absorber coating has gradient refractive index nature on stainless steel (SS 304) and exhibited high optical properties (α ≤ 0.95 & ε ≤ 0.14). The first absorber layer (Cr-Mn-Fe oxides) developed by controlled oxidation of SS 304 in a chemical bath reactor. A second composite layer of ZrO2-SiO2 has been applied on the chemically oxidized substrate by So-gel dip coating method to serve as optical enhancing and corrosion resistant layer. Finally, an antireflective layer (MgF2) has been deposited on the second layer, to achieve > 95% of absorption. The developed tandem layer exhibited good thermal stability up to 250 °C in open air atmospheric condition and superior corrosion resistance (withstands for > 200h in salt spray test (ASTM B117)). After the successful development of a coating with targeted properties at a laboratory scale, a prototype of the 1 m tube has been demonstrated with excellent uniformity and reproducibility. Moreover, it has been validated under standard laboratory test condition as well as in field condition with a comparison of the commercial receiver tube. The presented strategy can be widely adapted to develop highly selective coatings for a variety of CST applications ranging from hot water, solar desalination, and industrial process heat and power generation. The high-performance, cost-effective medium temperature receiver tube technology has attracted many industries, and recently the technology has been transferred to Indian industry.

Experimental Study on Effects of Addition of Rice Husk on Coal Gasification

In this experimental study, effects of addition of rice husk on coal gasification in a bubbling fluidized bed gasifier, operating at atmospheric pressure with air as gasifying agent, are reported. Rice husks comprising of 6.5% and 13% by mass are added to coal. Results show that, when rice husk is added the methane yield increases from volumetric percentage of 0.56% (with no rice husk) to 2.77% (with 13% rice husk). CO and H2 remain almost unchanged and CO2 decreases with addition of rice husk. The calorific value of the synthetic gas is around 2.73 MJ/Nm3. All performance indices, such as cold gas efficiency and carbon conversion, increase with addition of rice husk.

An Overview of Electronic Waste as Aggregate in Concrete

Rapid growth of world population and widespread urbanization has remarkably increased the development of the construction industry which caused a huge demand for sand and gravels. Environmental problems occur when the rate of extraction of sand, gravels, and other materials exceeds the rate of generation of natural resources; therefore, an alternative source is essential to replace the materials used in concrete. Now-a-days, electronic products have become an integral part of daily life which provides more comfort, security, and ease of exchange of information. These electronic waste (E-Waste) materials have serious human health concerns and require extreme care in its disposal to avoid any adverse impacts. Disposal or dumping of these E-Wastes also causes major issues because it is highly complex to handle and often contains highly toxic chemicals such as lead, cadmium, mercury, beryllium, brominates flame retardants (BFRs), polyvinyl chloride (PVC), and phosphorus compounds. Hence, E-Waste can be incorporated in concrete to make a sustainable environment. This paper deals with the composition, preparation, properties, classification of E-Waste. All these processes avoid dumping to landfills whilst conserving natural aggregate resources, and providing a better environmental option. This paper also provides a detailed literature review on the behaviour of concrete with incorporation of E-Wastes. Many research shows the strong possibility of using E-Waste as a substitute of aggregates eventually it reduces the use of natural aggregates in concrete.

Liability Aspects Related to Genetically Modified Food under the Food Safety Legislation in India

The question of legal liability over injury arising out of the import and the introduction of GM food emerges as a crucial issue confronting to promote GM food and its derivatives. There is a greater possibility of commercialized GM food from the exporting country to enter importing country where status of approval shall not be same. This necessitates the importance of fixing a liability mechanism to discuss the damage, if any, occurs at the level of transboundary movement or at the market. There was a widespread consensus to develop the Cartagena Protocol on Biosafety and to give for a dedicated regime on liability and redress in the form of Nagoya Kuala Lumpur Supplementary Protocol on the Liability and Redress (‘N-KL Protocol’) at the international context. The national legal frameworks based on this protocol are not adequately established in the prevailing food legislations of the developing countries. The developing economy like India is willing to import GM food and its derivatives after the successful commercialization of Bt Cotton in 2002. As a party to the N-KL Protocol, it is indispensable for India to formulate a legal framework and to discuss safety, liability, and regulatory issues surrounding GM foods in conformity to the provisions of the Protocol. The liability mechanism is also important in the case where the risk assessment and risk management is still in implementing stage. Moreover, the country is facing GM infiltration issues with its neighbors Bangladesh. As a precautionary approach, there is a need to formulate rules and procedure of legal liability to discuss any kind of damage occurs at transboundary trade. In this context, the proposed work will attempt to analyze the liability regime in the existing Food Safety and Standards Act, 2006 from the applicability and domestic compliance and to suggest legal and policy options for regulatory authorities.

Investigation of Tribological Behavior of Electrodeposited Cr, Co-Cr and Co-Cr/TiO2 Nano-Composite Coatings

Electrodeposition is a simple and economic technique for precision coating of different shaped substrates with pure metal, alloy or composite films. Dc electrodeposition was used to produce Cr, Co-Cr and Co-Cr/TiO2 nano-composite coatings from Cr(III) based electrolytes onto 316L SS substrates. The effects of TiO2 nanoparticles concentration on co-deposition of these particles along with Cr content and microhardness of the coatings were investigated. Morphology of the Cr, Co-Cr and Co-Cr/TiO2 coatings besides their tribological behavior were studied. The results showed that increment of TiO2 nanoparticles concentration from 0 to 30 g L-1 in the bath increased their co-deposition and Cr content of the coatings from 0 to 3.5 wt.% and from 23.7 to 31.2 wt.%, respectively. Microhardness of Cr coating was about 920 Hv which was higher than Co-Cr and even Co-Cr/TiO2 films. Microhardness of Co-Cr and Co-Cr/TiO2 coatings were improved by increasing their Cr and TiO2 content. All the coatings had nodular morphology and contained microcracks. Nodules sizes and the number of microcracks in the alloy and composite coatings were lower than the Cr film. Wear results revealed that the Co-Cr/TiO2 coating had the lowest wear loss between all the samples, while the Cr film had the worst wear resistance.

Fermentation of Xylose and Glucose Mixture in Intensified Reactors by Scheffersomyces stipitis to Produce Ethanol

In this work, two fermentations at different temperatures (25 and 30ºC), with cell recycling, were accomplished to produce ethanol, using a mix of commercial substrates, xylose (70%) and glucose (30%), as organic source for Scheffersomyces stipitis. Five consecutive fermentations of 80 g L-1 (1º, 2º and 3º recycles), 96 g L-1 (4º recycle) and 120 g L-1 (5º recycle)reduced sugars led to a final maximum ethanol concentration of 17.2 and 34.5 g L-1, at 25 and 30ºC, respectively. Glucose was the preferred substrate; moreover xylose startup degradation was initiated after a remaining glucose presence in the medium. Results showed that yeast acid treatment, performed before each cycle, provided improvements on cell viability, accompanied by ethanol productivity of 2.16 g L-1 h- 1 at 30ºC. A maximum 36% of xylose was retained in the fermentation medium and after five-cycle fermentation an ethanol yield of 0.43 g ethanol/g sugars was observed. S. stipitis fermentation capacity and tolerance showed better results at 30ºC with 83.4% of theoretical yield referenced on initial biomass.

The Role of Brand Loyalty in Generating Positive Word of Mouth among Malaysian Hypermarket Customers

Structural Equation Modeling (SEM) was used to test a hypothesized model explaining Malaysian hypermarket customers’ perceptions of brand trust (BT), customer perceived value (CPV) and perceived service quality (PSQ) on building their brand loyalty (CBL) and generating positive word-of-mouth communication (WOM). Self-administered questionnaires were used to collect data from 374 Malaysian hypermarket customers from Mydin, Tesco, Aeon Big and Giant in Kuala Lumpur, a metropolitan city of Malaysia. The data strongly supported the model exhibiting that BT, CPV and PSQ are prerequisite factors in building customer brand loyalty, while PSQ has the strongest effect on prediction of customer brand loyalty compared to other factors. Besides, the present study suggests the effect of the aforementioned factors via customer brand loyalty strongly contributes to generate positive word of mouth communication.

Improvement on a CNC Gantry Machine Structure Design for Higher Machining Speed Capability

The capability of CNC gantry milling machines in manufacturing long components has caused the expanded use of such machines. On the other hand, the machines’ gantry rigidity can reduce under severe loads or vibration during operation. Indeed, the quality of machining is dependent on the machine’s dynamic behavior throughout the operating process. For this reason, these types of machines have always been used widely and are not efficient. Therefore, they can usually be employed for rough machining and may not produce adequate surface finishing. In this paper, a CNC gantry milling machine with the potential to produce good surface finish has been designed and analyzed. The lowest natural frequency of this machine is 202 Hz corresponding to 12000 rpm at all motion amplitudes with a full range of suitable frequency responses. Meanwhile, the maximum deformation under dead loads for the gantry machine is 0.565*m, indicating that this machine tool is capable of producing higher product quality.

Synthesis and Characterization of Non-Aqueous Electrodeposited ZnSe Thin Film

A nanocrystalline thin film of ZnSe was successfully electrodeposited on copper substrate using a non-aqueous solution and subsequently annealed in air at 400°C. XRD analysis indicates the polycrystalline deposit of (111) plane in both the cases. The sharpness of the peak increases due to annealing of the film and average grain size increases to 20 nm to 27nm. SEM photograph indicate that grains are uniform and densely distributed over the surface. Annealing increases the average grain size by 20%. The EDS spectroscopy shows the ratio of Zn & Se is 1.1 in case of annealed film. AFM analysis indicates the average roughness of the film reduces from 181nm to 165nm due to annealing of the film. The bandgap also decreases from 2.71eV to 2.62eV.

Control Configuration Selection and Controller Design for Multivariable Processes Using Normalized Gain

Several of the practical industrial control processes are multivariable processes. Due to the relation amid the variables (interaction), delay in the loops, it is very intricate to design a controller directly for these processes. So first, the interaction of the variables is analyzed using Relative Normalized Gain Array (RNGA), which considers the time constant, static gain and delay time of the processes. Based on the effect of RNGA, relative gain array (RGA) and NI, the pair (control configuration) of variables to be controlled by decentralized control is selected. The equivalent transfer function (ETF) of the process model is estimated as first order process with delay using the corresponding elements in the Relative gain array and Relative average residence time array (RARTA) of the processes. Secondly, a decentralized Proportional- Integral (PI) controller is designed for each ETF simply using frequency response specifications. Finally, the performance and robustness of the algorithm is comparing with existing related approaches to validate the effectiveness of the projected algorithm.

Transient Enhanced LDO Voltage Regulator with Improved Feed Forward Path Compensation

Anultra-low power capacitor less low-dropout voltage regulator with improved transient response using gain enhanced feed forward path compensation is presented in this paper. It is based on a cascade of a voltage amplifier and a transconductor stage in the feed forward path with regular error amplifier to form a composite gainenhanced feed forward stage. It broadens the gain bandwidth and thus improves the transient response without substantial increase in power consumption. The proposed LDO, designed for a maximum output current of 100 mA in UMC 180 nm, requires a quiescent current of 69 )A. An undershot of 153.79mV for a load current changes from 0mA to 100mA and an overshoot of 196.24mV for current change of 100mA to 0mA. The settling time is approximately 1.1 )s for the output voltage undershooting case. The load regulation is of 2.77 )V/mA at load current of 100mA. Reference voltage is generated by using an accurate band gap reference circuit of 0.8V.The costly features of SOC such as total chip area and power consumption is drastically reduced by the use of only a total compensation capacitance of 6pF while consuming power consumption of 0.096 mW.

Solving Directional Overcurrent Relay Coordination Problem Using Artificial Bees Colony

This paper presents the implementation of Artificial Bees Colony (ABC) algorithm in solving Directional OverCurrent Relays (DOCRs) coordination problem for near-end faults occurring in fixed network topology. The coordination optimization of DOCRs is formulated as linear programming (LP) problem. The objective function is introduced to minimize the operating time of the associated relay which depends on the time multiplier setting. The proposed technique is to taken as a technique for comparison purpose in order to highlight its superiority. The proposed algorithms have been tested successfully on 8 bus test system. The simulation results demonstrated that the ABC algorithm which has been proved to have good search ability is capable in dealing with constraint optimization problems.

Factors for Entry Timing Choices Using Principal Axis Factorial Analysis and Logistic Regression Model

International market expansion involves a strategic process of market entry decision through which a firm expands its operation from domestic to the international domain. Hence, entry timing choices require the needs to balance the early entry risks and the problems in losing opportunities as a result of late entry into a new market. Questionnaire surveys administered to 115 Malaysian construction firms operating in 51 countries worldwide have resulted in 39.1 percent response rate. Factor analysis was used to determine the most significant factors affecting entry timing choices of the firms to penetrate the international market. A logistic regression analysis used to examine the firms’ entry timing choices, indicates that the model has correctly classified 89.5 per cent of cases as late movers. The findings reveal that the most significant factor influencing the construction firms’ choices as late movers was the firm factor related to the firm’s international experience, resources, competencies and financing capacity. The study also offers valuable information to construction firms with intention to internationalize their businesses.

Effect of DG Installation in Distribution System for Voltage Monitoring Scheme

Loss minimization is a long progressing issue mainly in distribution system. Nevertheless its effect led to temperature rise due to significant voltage drop through the distribution line. Thus, compensation scheme should be proper scheduled in the attempt to alleviate the voltage drop phenomenon. Distributed generation has been profoundly known for voltage profile improvement; provided that over-compensation or under-compensation phenomena are avoided. This paper addresses the issue of voltage improvement through different type DG installation. In ensuring optimal sizing and location of the DGs, pre-developed EMEFA technique was made use for this purpose. Incremental loading condition subjected to the system is the concern such that it is beneficial to the power system operator.

The Growth of the Watermelons with Geometric Shapes and Comparing Retention between Cubic and Hexagonal Forms

Shape and form of the watermelon fruits are important factors to save spaces and reducing damage during storing of the fruits. In order to save spaces and prevent fruit damage in watermelon the following experiment was carried out in the farm. The fruits were boxed when they were approximately one cm less than the box diameter. The cubic, hexagonal forms were compared in this research. To do this, different boxes were designed with different holes on the sides to holes the watermelons fruits for shaping. The shapes of the boxes were hexagonal and cubic. The boxes holes sizes were the same with 10mm diameter each. Each side of the boxes had different holes including: without holes to 75 holes. The result showed that the best shape for watermelon storing to save space and prevent fruit damage was hexagonal form. The percentages of the fruit damage were 33 to 80 respectively.