Terms Of Product Quality Research Articles

Validating Pharma Machinery: A Journey to Find a Line Somewhere Above Baseline with Science and Risk Consideration for Cost Efficient Facility Requirement

Every industry should be aware about how their product quality are build. It began with the end in mind about a detail specification of the product, a quality attribute designed to the product profile, process and technology choice. Then it will initiate a requirement of the facility for those need. Pharmaceutical product is one in many manufacturing industries that need to be carefully manage in term of product quality and the consideration that it can be harm to the consumer. The impact can also come from a requirement specification of its facility1. To protect the drugs consumer, we can use the term ‘patient safety’ then, authority made a regulation that became a corridor to lead the industry on how the good manufacturing practices should be conducted. Regulator put it in the terminology: GMP (Good Manufacturing Practices). But they give only general statement about what a ‘good manufacturing’ is. Most of the time it needs detail technical explanation. Especially for the engineers’ perspective. Some pharmaceutical engineering professional organization try to describe the minimum requirement should be designed for pharmaceutical facility purpose. A Baseline. But the baseline sometimes is not a clear bold line, most of the time, in very detail technical decision, it can be a wide grey area. How high we put our requirement level above baseline correlate with how expensive the cost will be.

أثر اختلاف قالب الفصل الافتراضي في تنمية المهارات المعرفية وجودة إنتاج الانفوجرافيك وسهولة الاستخدام

This study aims at pointing out the impact of "lobby mode" versus that of "analytical mode" on developing cognitive skills, quality of production and usability of the model system; all through using Adobe Connect. An achievement was developed and it consisted of 20 lexicon to measure the cognitive skills of instructional infographic design. In addition, an assessment card has been used to assess the final production in terms of quality. The card is composed of 44 texts designed to measure the quality of infographic. Besides, a measuring scale has been founded, that is composed of 55 phrases distributed among five areas; thus to measure the usability of using the virtual classroom module. The study focus groups were randomly selected of the students of Educational Technology Program, specifically, second semester of an academic year 2016/2017. Forty students have been selected and divided into two experimental groups. In terms of usability, results of the study showed up that the analytical model has been proven better than the lobby one in managing a virtual classroom using adobe connect system; whereas same results highlighted a no statistically documented difference between both models in terms of cognitive skills related to instructional infographic design together with level a d quality of production.

Work ability and productivity among dentists: associations with musculoskeletal pain, stress, and sleep

PurposeWork ability can be measured by the work ability index (WAI), and work-related questions measuring productivity loss in terms of quality and quantity of work. Dentists have high occupational risk of musculoskeletal pain and the exposure of ergonomic strain is already high during dental education. The aim was to evaluate work ability and productivity among dentists, and to identify gender differences and associations with sleep, stress, and reported frequent pain.MethodsThe study population comprised 187 dentists (123 women and 64 men) who had been working as dentists between 5 and 12 years. Participants completed a questionnaire regarding sleep, stress, presence of pain at different sites, work ability assessed by WAI, and productivity in terms of quality and quantity of work.ResultsPoor sleep quality and high level of stress were reported by 31% and 48.1% of participants, respectively, with no gender differences and no association with age. The prevalence of frequent pain ranged 6.4–46.5% with shoulders being the most prevalent site. Thirty-three percent reported reduced work ability. Poor sleep, high amount of stress, and multi-site pain were associated with decreased work ability.ConclusionsA high prevalence of pain was shown among dentists. Decreased work ability in terms of productivity loss was associated with poor sleep quality, high amount of stress, and multi-site pain. Preventive actions at the workplace should promote good musculoskeletal health, and measures taken, both individual and organizational, to minimize the risk of high, persistent stress and work-related pain.

Multivariate data analysis of growth medium trends affecting antibody glycosylation.

Use of multivariate data analysis for the manufacturing of biologics has been increasing due to more widespread use of data‐generating process analytical technologies (PAT) promoted by the US FDA. To generate a large dataset on which to apply these principles, we used an in‐house model CHO DG44 cell line cultured in automated micro bioreactors alongside PAT with four commercial growth media focusing on antibody quality through N‐glycosylation profiles. Using univariate analyses, we determined that different media resulted in diverse amounts of terminal galactosylation, high mannose glycoforms, and aglycosylation. Due to the amount of in‐process data generated by PAT instrumentation, multivariate data analysis was necessary to ascertain which variables best modeled our glycan profile findings. Our principal component analysis revealed components that represent the development of glycoforms into terminally galacotosylated forms (G1F and G2F), and another that encompasses maturation out of high mannose glycoforms. The partial least squares model additionally incorporated metabolic values to link these processes to glycan outcomes, especially involving the consumption of glutamine. Overall, these approaches indicated a tradeoff between cellular productivity and product quality in terms of the glycosylation. This work illustrates the use of multivariate analytical approaches that can be applied to complex bioprocessing problems for identifying potential solutions.

Process efficiency of electromagnetic radiation (EMR)‐assisted hybrid drying in spearmint ( Mentha spicata L. )

Spearmint (Mentha spicata L.) leaves were dried using four different methods, namely, infrared-hot air (IR-HA) drying, radiofrequency-hot air (RF-HA) drying, low-humidity air (LHA) drying, and hot air (HA) drying at three different temperatures (30, 40, and 50°C). The effect of the methods on time required for drying, product quality in terms of chlorophyll, total carotenoids, essential oil yield and its composition, color, browning index (BI), and rehydration ratio was evaluated. The IR-HA hybrid drying at 50°C resulted in faster process with nearly 62% lesser drying time, as compared to HA drying, and also resulted in higher retention of essential oil (85.7%), carvone (79.6%), and lower BI (50.4). The specific energy requirement of IR-HA hybrid drying reduced by 60% as compared to HA drying at 50°C. The results showed that hybrid drying involving IR could be effectively used to obtain good quality of dried spearmint leaves in a shorter time with better energy efficiency. Practical applications Spearmint is popular for essential oil, and carvone is the major volatile compound present in the oil, giving its characteristic odor. This study explored the effect of drying methods (IR-HA, RF-HA hybrid drying, and LHA drying) on drying characteristics, quality of dried spearmint and its comparison with HA drying. The study showed that IR-HA drying resulted in shorter processing time with a higher yield of essential oil, carvone retention, and energy efficiency than other drying methods. The results indicated that IR-HA hybrid drying technique could be explored as an alternative to HA drying of heat-sensitive herbs like spearmint.

An optimum modern spinning methods achieving physiological comfort in circular weft knitting fabrics.

Multiplication cotton yarn spinning methods, which produce yarns with various specifications and characteristics, as well as the multiplicity production process and production costs. Therefore, these yarns must be codified according to the nature of use of final product of both circular weft knitting fabrics single jersey and rib (1×1) which saves time, low cost, increase production, reflected on different characteristics of physiological comfort of both circular weft-knitting fabrics, quality and final product costs. Choosing cotton spinning method that is suitable for both circular weft knitting fabrics single jersey, rib (1×1) based on personal diligence (harming to the final product in terms of quality, final cost and physiological comfort to the end user) without reference to scientific and experimental standards accurate. Contribute to the activation of modern technological methods of cotton spinning method production field. The scarcity of experimental and analytical studies for both circular weft knitting fabrics single jersey, rib (1×1) and the related physical, mechanical and aesthetic properties related to the modern spinning methods of cotton yarn production to achieve physiological comfort in different forms of weft knitting fabrics for the end user. Objectives : Determination the best modern cotton spinning methods achieving the physiological comfort in both circular weft knitting fabrics single jersey and rib (1×1), through both functional, motive, thermal, tactile, psychological and appearance characteristics without affecting on the physical and mechanical properties of produced fabrics and Determination the best weave structure of circular weft knitting fabrics single jersey, rib (1×1) achieving physiological comfort for the body using different yarn spinning methods. . Methodology : The research follows the analytical and experimental method. Results : Both circular weft-knitting fabrics single jersey, rib (1×1) produced from the compact combed yarn have the highest value in both the explosion resistance of the fabrics (Kilo Pascal), air permeability of the fabrics (ft3/ft2/min) and have low value in both fabrics thickness (mm), fabrics weight (gm/m2) for many reasons. Both circular weft-knitting fabrics single jersey, rib (1×1) produced from Open-end spinning yarn have the highest value in both fabrics weight (gm/m2), fabrics water absorption (%) and have lowest value in both explosion resistance of the fabrics (Kilo Pascal) for many reasons. Both circular weft-knitting fabrics single jersey, rib (1×1) produced from carded combed yarn spinning have the highest value in fabrics air permeability (ft3/ft2/min) for many reasons. Both circular weft-knitting fabrics single jersey, rib (1×1) produced from carded ring spinning yarns have the lowest value in both fabrics thickness (mm) for many reasons. Circular weft-knitting fabrics single jersey produced from compact combed yarn is the highest level in achieving physiological comfort (Sensory, thermal, motive and psychological) of the circular weft-knitting fabrics rib (1×1). Because of its high explosion resistance (Kilo Pascal) and fabrics air permeability (ft3/ft2/min), lowest fabrics thickness (mm), less water absorption (%) and has soft feel and therefore high resistance to wrinkle and crumbly regain its shape and appearance easily due to its weave structure

Study on the Pattern of Antibiotic Use Including the Resistance Episodes in Bangladesh

Antibiotic resistance is currently one of the biggest challenges faced by the health professionals worldwide. Bacteria are becoming resistant to commonly used antibiotics and various factors have been identified that are responsible for the resistance. Factors like poor quality of antibiotic products, unethical marketing practices by pharmaceutical companies, irrational use of antibiotics by the physicians and patient incompliance are also common in Bangladesh. To carry out this study, firstly the extent of antibiotic resistance was evaluated by collecting clinical isolates from various diagnostic centers of Dhaka City and conducting antibiotic susceptibility test against commonly used antibiotics. The product quality was evaluated by collecting antibiotic products of different generics from various locations around Bangladesh and then performing drug content assay by HPLC method. Finally, to evaluate patient incompliance, a questionnaire-based survey was conducted on patients who took or had taken antibiotics recently and the collected data was analyzed statistically. The result of the investigation reveals that more than 80% of the collected Escherichia coli (E. coli) isolates were resistant to currently used antibiotics like, azithromycin, ciprofloxacin, amoxicillin, cefixime, cefuroxime, and moxifloxacin. Similar holds true for the collected Staphylococcus aureus (S. aureus) isolates. The product quality in terms of drug content and dissolution was good for most products irrespective of whether the manufacturer had a high market value or not. Patients survey revealed that 82% discontinued antibiotic therapy was due to carelessness (49%), a false sense of cure (36%) and high cost (15%).
 Dhaka Univ. J. Pharm. Sci. 18(2): 135-143, 2019 (December)

Optimization Using Solvent-Free Microwave Hydro-diffusion Gravity Extraction of Onion Oil from Allium cepa by Response Surface Methodology

Extraction from Allium cepa using solvent-free microwave extraction (SFME) without solvent was chosen as a method in the extraction process. The method is combined with microwave hydro-diffusion gravity (MHG) technique. In this paper, onion oil was extracted from Allium cepa using solvent-free microwave hydro-diffusion gravity extraction which is as an alternative technique to produce onion oil and it has several advantages in terms of product quality and high yield. The highest yield was obtained from this research at 100 g, 450 W and 15 min is 2.5875%. Furthermore, response surface methodology (RSM) was designed to evaluate the effects of mass of raw material (g), microwave power (W) and extraction time (min) for optimization of experimental data. Response surface methodology gave the optimum condition at 99.738 g, 465.067 W, and 17.817 min is 2.677%. The error rates between the experimental and predicted model which are less than 5% indicate that values obtained in optimal conditions correspond to theoretical values and it can be used as a reference for optimizing

Isı Pompalı İnfrared Kurutucuda Dilimlenmiş Limonun Kurutulmasının Performans Analizi

In this study, drying sliced lemons with an infrared-heat pump dryer is analyzed. The testing apparatus is designed for two different systems: closed air loop and fresh air inlet. Experiments are competed with same values for both systems and the effects of these systems on drying kinetics are compared. 5mm thick sliced lemons are dried from 6,6804 g water/ g dry matter moisture content to 0,045 g water/ g dry matter moisture content at 60 °C constant temperature and 595 m³/h inlet air flow. The drying process completed in 5 hours with closed air loop system and in 6 hours with fresh air inlet system. In the literature studies, drying of the lemon slices in the infrared dryer was examined and drying process completed at 8 hours. The average COPws value calculated as 2,67 for fresh air inlet system and 2,74 for closed air loop system. According to experiments, drying time decreased 16,67% on closed loop system as against fresh air inlet system. Visual analysis of dried lemons showed no difference between the two systems in terms of product quality. It is considered that evaluating of lemon by drying process which has an important place in the domestic and international markets, will contribute greatly to the economy of the country.

Influence of Different Drying Techniques on Phenolic Compounds, Antioxidant Capacity and Colour of Ziziphus jujube Mill. Fruits.

This study was to present the effect of different parameters of combined methods of drying such as vacuum-microwave (VMD: 480, 120 W), hot air (CDD: 70, 60, 50 °C) and combined methods as pre-drying by CD and finish drying by VMD (CD-VMD: 60 °C + 480/120W) in order to avoid a rapid increase in temperature at the critical moisture content of ca. 1 kg/kg dm (dry mass). Control samples were prepared by freeze-drying (FD). Drying kinetics, including the temperature profile of dried material, as well as on some quality factors of the finished product as phenolic compounds, antioxidant capacity, and color were evaluated. The increase in air temperature during CD as well as the increase in material temperature during VMD deteriorated dried product quality in terms of the content of phenolic compounds, antioxidant activity and color. Dried jujube fruits have a long shelf life and therefore may be a fine alternative to fresh fruit all year round.

Bio-Supply Chain Network Design to tackle ethanol deficiency in India: A mathematical framework

To deal with the rising demand of fossil fuels and their associated untoward environmental and economic effects, the feasibility of Indian government's green move towards blending of 20% fuel grade ethanol with gasoline has been studied by performing techno-economic-environmental analysis of second generation lignocellulose biomass as feedstock. An optimized supply chain network (SCN) has been designed with four layers of structure starting from raw material suppliers to the retailers through the layers of the manufacturers and the distributors aiming at the net present value (NPV) maximization. The cost calculation includes operating expenditure (OPEX) and capital expenditure (CAPEX) components involving transport, storage, production and import decisions as linear variables and decisions on connections between two nodes between two consecutive layers as binary variables. The distribution layer of the mixed integer linear programming (MILP) model has been uniquely designed for the imported ethanol to serve the twin purposes of meeting the unmet demand as well as enhancing the bio-ethanol product quality in terms of research octane number. The revenue generation is calculated not only from selling the final product but also from the carbon credits calculated using greenhouse gas emission (GHGe) during project life cycle assessment. Further, sensitivity analysis has been performed to show the effect of various parameters such as modes of transport, transport distance limitation on feedstock and product, number of zones, international fuel price fluctuations, feedstock availability on NPV. With ∼80% increase in demand over the 9-year planning horizon, a dynamically changing supply chain (SC) structure shows a ∼36% increase in the newly added locations. Feed availability, critical for Indian scenario, to the tune of at least 40% of the capacity is needed to meet the projected demands.

The peculiarity of the control of dairy products in terms of quality and safety

The peculiarity of the control of dairy products in terms of quality and safety

Eating Hamburgers Slowly and Sustainably: The Fast Food Market in North-West Italy

The Italian food movement shows some peculiarities of meeting consumer demand in the foodservice subsector where innovation is considered strategic to meet targets and reach goals. A particular kind of innovation is the return to tradition by enhancement of the territory, e.g., reinstating local recipes and local gastronomy or high-quality local raw materials. Some entrepreneurs are redefining the fast-food service, providing foodstuffs through a short supply chain. The aim of this paper is to identify the different hamburger foodservices operating in North-West Italy and address their diverse peculiarities. A sample of 11 hamburger restaurants was identified, a mystery shopping analysis was implemented to collect information on the foodservice phenomenon, and a Business Model Canvas was carried out to compare different foodservices. The results consider two different hamburger foodservices, i.e., International Hamburger Foodservice (IHF) and Local Hamburger Foodservice (LHF), the former concentrating mainly on customer service, human resource management, and operations management, and the latter focussing on high product quality in terms of materials and psychology, plus selection of local raw materials and ingredients, supporting the local economy and businesses. Moreover, the findings provide some information on the interaction between selected Hamburger Foodservices and related supply chains, highlighting the consumer transition toward meals of high quality standards in terms of raw materials and ingredients.

The quality of semi-finished steel

The article deals with the quality of structural steel supplied by metallurgical enterprises. It is shown that the pipes made of steel 20, used in the oil and gas industry, contain structurally free cementite in the structure, often in the form of a grid (points 4 and 5 according to GOST 5640–68). This structure is the cause of faulty production: the subsequent cold treatment pressure formed sags on the surface of the product, and there is a violation of the continuity of the material up to the formation of through cracks. Formation of structurally-free cementite in steel 40KHN2MA with structure of the top bainite which was formed at violation of regulations of heat treatment of a semi-finished product is also found. When nitriding with heating to 490 ° C and holding at this temperature, there was a decay of bainite with the formation of tertiary cementite along the grain boundaries. Discussed the possibility of culling the poor quality of delivery at the consumer. It is also noted that many enterprises have now abolished entrance control, which has the most negative consequences both in terms of product quality and safety, especially in the oil and gas industry.

Evaluation of vacuum impregnation as a novel approach for soaking of fried Gulabjamun balls.

Vacuum impregnation of sugar syrup into sub-baric fried Gulabjamun was evaluated as a technological approach to prepare a product of most acceptable quality. Sugar syrup concentrations (40, 50 and 60°Brix) in combination with process time (2, 4 and 6min) were analyzed for their effect on product quality in terms of its overall acceptability, expansion ratio, hardness, juiciness and sugar content. The effect of the process conditions on the five listed responses during the vacuum impregnation process was evaluated using response surface methodology and modelled using a second order polynomial equation. The optimum combination was obtained as soaking in a syrup of 55°Brix for 5min and was experimentally validated for its real time adequacy. The experimental values of the quality parameters thus obtained were found to be in close agreement with the predicted values.

FAILURE OF EMPLOYEE RETENTION AND ITS CONSEQUENCES ON ORGANISATION THROUGH CONTENT ANALYSIS

For any organization its workforce are the most valuable assets. Their implication to system describes not only the requirement to pull the best competence but also the need to hold on to them for a long term.
 With evolution of globalization, competition is becoming keener and keener in most industries. These conditions affect the employment in the notion that companies insist on human capital to sustain in the market for a longer period of time. A proper retention strategy improves the performance of organisation in terms of product quality and profitability ratio.
 The biggest challenge in current work scenario is how to engage people on the job as long as possible by carving a proper career path for them and shaping their future prospects in job.
 The concept of employee retention is mainly motivating employees to stay in an association for a maximum period of time (Bidisha etal 2013). As Mita (2014) defined employee retention “is a tool accepted by companies to maintain an efficient fleet of workers and consecutively meet functional requirements Based on actual facts and findings, retaining the best employees makes sure client satisfaction, increase in product sales, peer satisfaction and effective succession planning. An entrenched organizational knowledge and learning which means, imparting proper training time and investment on regaining lost knowledge of employees, helps gaining back job security and a costly employee is won back. Thus, failing to which leads to a loss of important employees. A range of approximation suggests that losing a middle manager in most organizations costs up to five times his salary. Corporate were facing lot of problems in retention of employees these days. To hire well-informed people for the job is essential for an employer, but retention is even more important than hiring.

Biological Therapies in Immune-Mediated Inflammatory Diseases: Can Biosimilars Reduce Access Inequities?

Biological therapies are an effective treatment for a range of immune-mediated inflammatory diseases (IMIDs), including rheumatoid arthritis, psoriasis, and inflammatory bowel diseases. However, due to their high costs, considerable differences in their utilization exist across the world, even among the various European countries, with many countries restricting access despite professional society guideline recommendations. Adoption of biologics by healthcare providers has been particularly poor in many Central and Eastern European countries. Differences in utilization have also been observed across medical specialties, healthcare providers, and at a regional and national level. The objective of this paper is to provide an overview of the different market access policies for biologics in Europe and to investigate reasons for such differences. One of the potential solutions for providing broader access to IMID patients, where cost is the major barrier, is to encourage the use of biosimilars in place of their reference products. Biosimilars are generally less expensive alternatives to already licensed biological therapies and are approved on the basis that they are similar to the reference product in terms of quality, safety, and efficacy. Budget impact models predict considerable cost savings following the introduction of biosimilars in the next few years. These savings could be used to increase access to biologics and other innovative therapies.

Developing Computer–Based Instructional Media for English Speaking Skill at Senior High School

This research aimed at developing computer-based instructional media using Adobe Flash for the tenth graders’English speaking skill material. The studyemployed research and development method. The results showed (1) the product is a computer-based instructional media in a combined format of tutorial and drilling facilitating semiinteractive learning consisting of thanking, complimenting, congratulating, surprise and disbelief materials; (2) the expert validation showed that the product quality in terms of media is categorized very good (4.51) and in terms of the material and instructionalare categorized good (3.91). The results of the field trials showed that the quality of the product in terms of material, media, and instructional is categorized very good (4.32). In conclusion, the developed media is eligible to be implemented in speaking learning activities. Keywords: computer-based instructional media; Adobe Flash; speaking skill

Couponing Strategies in Competition Between a National Brand and a Private Label Product

This paper explores the couponing strategies when a national brand competes with a store brand by discussing three different kinds of coupons: manufacturers’ coupons, retailers’ national brand coupons, and retailers’ private label coupons. We show that the positioning of the private label product in terms of quality and feature differentiation from the national brand play an important role in determining the face value of the manufacturer's coupon and retailer's national brand coupon. In particular, a larger degree of feature differentiation drives the manufacturer to increase its coupon value, and the retailer responds by decreasing the value of its own coupon for the brand name product. In contrast, with an increase in private label quality, the couponing strategies taken by the manufacturer and the retailer depend on which segment of consumers is in the market for the private label product. Additionally, the retailer's private label coupon value is only impacted by the difference in consumers’ willingness to pay but not by private label positioning. Empirical results on the effect of feature differentiation on national brand and private label coupon values are consistent with our theoretical predictions.

Demonstration of functional similarity of a biosimilar adalimumab SB5 to Humira®

A biosimilar is a biological medicinal product that is highly similar to an authorized biological product in terms of quality, biological activity, safety and efficacy. SB5 was developed by Samsung Bioepis as a biosimilar referencing adalimumab, and was authorized by the European Commission (EC) in August 2017 (Imraldi®). Extensive characterization studies were performed to demonstrate functional similarity of SB5 to reference adalimumab (Humira®, AbbVie Inc. and AbbVie Deutschland GmbH & Co. KG). SB5 and Humira® showed highly similar soluble TNF-α binding and neutralizing activity, as well as transmembrane TNF-α binding activity and reverse signaling induced in the membrane TNF-α expressing cell line. Both products exhibited similar binding of the Fc gamma receptors and Fc-related effector functions such as antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). In addition, additional mechanisms of action induced by TNF-α, such as cytokine release and expression of adhesion molecules, were analyzed and shown to be similar between SB5 and Humira®. Taken together, our results demonstrate that SB5 and Humira® are highly similar in terms of their functional characteristics.