Quality Control Development Research Articles

The clinical pathway in China county for lung cancer diagnosis and treatment (2024 edition)

Standardizing the diagnosis and treatment of lung cancer is a key measure to improve the survival rate of lung cancer patients and reduce the mortality rate. However, county hospitals generally face the problem of inaccessibility to advanced diagnostic and treatment technologies. Therefore, when developing quality control standards and clinical diagnosis and treatment specifications, it is necessary to combine the actual situation of county hospitals and formulate specific recommendations. The recommendations of treatment measures also need to consider the approval status of indications and whether it is included in the National Reimbursement Drug List (NRDL), to ensure the access to medicines. To address the above issues, based on the existing guidelines at home and abroad and the clinical work characteristics of county hospitals, the " the clinical pathway in China county for lung cancer diagnosis and treatment (2024 edition)" has been updated on the basis of the first edition. This pathway elaborated on the imaging diagnosis, pathological diagnosis, molecular testing, precision medicine, and developed different diagnosis and treatment processes for different types of lung cancer patients. Consistent with the first pathway, this update still divides the recommendations for diagnosis and treatment of clinical scenarios into basic strategies and optional strategies for elaboration. The basic strategies are the standards that county hospitals must meet, while the optional strategies provide more choices for hospitals, which are convenient for county doctors to put into clinical practice. All the recommended diagnostic and treatment plans strictly refer to existing guidelines and consensus. Compared to the first edition, based on the latest high-level evidence-based medicine and the approval status of indications, the pathway has updated the diagnosis and treatment recommendations for lung cancer under different pathological types, TNM classification, and molecular classification in basic and optional strategies.

Evaluation of size-based distribution of components in VYXEOS® liposomal formulation using asymmetric flow field-flow fractionation

VYXEOS® is the first FDA-approved dual-API liposomal formulation containing two different chemotherapeutics, daunorubicin and cytarabine at a 1:5 molar ratio. Analysis of bulk formulation does not provide insight to size-based distribution of APIs and excipients, therefore asymmetrical flow field-flow fractionation (AF4) was utilized for the size-based separation of VYXEOS® liposomes and collected size fractions were further analyzed for the concentrations of APIs, lipid excipients, and copper. Analysis results revealed a significant variation in API distribution across the size fractions, with the larger liposomes encapsulating a higher ratio of cytarabine to daunorubicin compared to the smaller liposomes, while lipid excipient composition was held constant across the size range. We attribute the size-based variation of API ratios to structural change during API loading and sequence of API loading. Cytarabine is first passively loaded into liposomes containing copper gluconate, and then daunorubicin is actively loaded using copper gradient where the daunorubicin is retained in the liposomes as a copper complex. This method can be extended to characterize various single and dual-API liposomal nanocarriers during drug product development and/or post market quality control.

Scientifc Validation and Chromatographic Method Development for the Estimation of Piperine in Herbal Formulation Babbularishta: A Quality Control Strategy for Critical Quality Attributes

Background: Babbularishta is an Ayurvedic medicine in liquid form used for the treatment of phthisis, skin diseases, urinary disorders,, and breathing problems. It is also beneficial in cases of blood disorders, acne, dermatitis, hemoptysis, lung injury, asthma, persistent cough, whooping cough, etc. Objective: The functional role of this study is to develop a simple, novel, precise, accurate, reliable, and selective RP-HPLC method for the estimation of piperine content in herbal drug formulations (Babbularista). Methods: A traditional approach to method development could fail to meet the desired separation. Consideration of the current regulatory requirement for analytical method development and RP-HPLC method for routine analysis of piperine in the herbal formulation has been optimized using an analytical Quality by Design (QbD) approach. Three laboratory formulations and three marketed preparations of Babularishta were investigated for organoleptic parameters, physicochemical parameters, and validation. The mobile phase composition (methanol and water % as A), pH (B), and flow rate (mL/min as C) were selected as independent variable,. In contrast, retention time (min. as Y2), area (AU as Y1) is selected as dependent variables. Results: The fingerprinting method was developed and optimized by using the AQbD approach. Piperine content was found to be in Piper nigrum (Marica) 3.01±0.01527 % w/w and in Piper longum (Pipali) 2.74±0.01154% w/w in Babbularista. Conclusion: An attempt has been made to develop quality control parameters of Babbularista by developing a suitable and sensitive HPLC methods for the quantitation of piperine in herbal drug formulations (Babbularista). The developed method was found to be simple, accurate, precise,, and economical for the estimation of piperine in herbal formulations.

Characterization of adeno-associated virus capsid proteins using denaturing size-exclusion chromatography coupled with mass spectrometry

Recombinant adeno-associated viruses (AAVs) are a highly effective platform for gene delivery for the treatment of many human diseases. Characterization of AAV viral protein attributes (VP), such as serotype identity, VP stoichiometry, and VP post-translational modifications, is essential to ensure product and process consistency. While size-exclusion chromatography (SEC) coupled with mass spectrometry (MS) is commonly used in the biopharmaceutical industry for analyzing protein therapeutics, its application to intact AAV VP components has not gained traction, presumably due to difficulties in achieving adequate resolution of VP(1−3) monomers. Herein, we describe the development of a denaturing SEC method and optimization of SEC parameters, including stationary phase pore size, column temperature, and mobile phase composition, to achieve effective chromatographic separation of VP(1−3). We demonstrate that an optimized dSEC-MS method featuring MS-compatible formic acid, can effectively separate VP(1−3) across AAV1, 2, 5, 6, 8, and 9 serotypes using a single column and mobile phase condition. A case study was included to showcase successful application of the dSEC-MS method in analyzing changes across different AAV production processes, yielding similar conclusions to an orthogonal approach, such as hydrophilic interaction chromatography (HILIC)- MS. Additionally, dSEC integrated with fluorescence (FLR) and ultraviolet (UV) detection can be used to semi-quantitatively identify both AAV DNA and VP components from empty and full AAV samples. Overall, this robust and MS-friendly methodological advancement could greatly streamline the development and analytical quality control processes for AAV-based gene therapies, providing a highly sensitive method for intact VP characterization.

A focus on the Chinese stingless bee honey (Hymenoptera, Apidae, Meliponini): Exploring physicochemical parameters for establishing quality standards

Stingless bee honey (SBH) is the most important product from stingless bee colonies with great economic value and health benefits. Nevertheless, there is little information on the physiochemical parameters of Chinese SBH, which also limits its utilization and quality control. In the period 2019–2023, we collected 89 Chinese SBH samples produced by five stingless bee species from four provinces in China. We performed comprehensive assessments of various SBH physicochemical indicators. These parameters include moisture, trehalulose, sucrose, fructose, glucose, total soluble solids, Baumé, ash, pH, electrical conductivity, 5-hydroxymethylfurfural, and free acidity. Our data revealed that the physicochemical parameters of Chinese SBH are consistent with earlier reported results from other countries. Notably, the Chinese SBH exhibited a relatively low level of 5-hydroxymethylfurfural (0–9.64 mg/kg), sucrose (0–0.43 g/100 g), and no diastase activity was detected. Chinese SBH was rich in trehalulose (4.26–37.65 g/100 g). After comparing these indexes with published data and with Australian/Malaysian samples, we proposed a new food standard for regulations of Chinese SBHs. These findings provide crucial insights into the Chinese SBH and contribute significantly to developing quality control and global standards for SBH.

A comprehensive study on the identification and characterization of major degradation products of synthetic liraglutide using liquid chromatography-high resolution mass spectrometry.

Liraglutide (LGT) is a synthetic glucagon-like peptide-1 analogue mainly used for the treatment of type-2 diabetes or obesity. Comprehensive stability testing is essential in the development and routine quality control of synthetic therapeutic peptide pharmaceuticals. The GLP-1 peptide drugs are usually formulated in aqueous-base solution, which can generate stability issues during manufacturing, storage or shipment. The current study endeavors to observe the chemical stability behavior of LGT by exposing the drug substance to oxidative and hydrolytic stress conditions. A simple liquid chromatography (LC) method was developed where sufficient resolution between LGT and the generated degradation products was achieved. In total, 19 degradation products (DPs) were separated under acidic, basic and oxidative stress conditions. Using LC-HRMS, MS/MS studies, the generated degradation products were identified and characterized. The mechanistic fragmentation pathway for all generated DPs were established and the plausible chemical structure for the identified DPs was predicted based on MS/MS data. The results strongly suggest that LGT is highly susceptible to degrade under oxidative and hydrolytic conditions. Furthermore, this study provides insights into the hydrolytic and oxidative stability of LGT, which can be implied during generic and novel formulation drug development and discovery in synthesizing relatively stable GLP-1 analogues.

Improving quality control of whole slide images by explicit artifact augmentation

The problem of artifacts in whole slide image acquisition, prevalent in both clinical workflows and research-oriented settings, necessitates human intervention and re-scanning. Overcoming this challenge requires developing quality control algorithms, that are hindered by the limited availability of relevant annotated data in histopathology. The manual annotation of ground-truth for artifact detection methods is expensive and time-consuming. This work addresses the issue by proposing a method dedicated to augmenting whole slide images with artifacts. The tool seamlessly generates and blends artifacts from an external library to a given histopathology dataset. The augmented datasets are then utilized to train artifact classification methods. The evaluation shows their usefulness in classification of the artifacts, where they show an improvement from 0.10 to 0.01 AUROC depending on the artifact type. The framework, model, weights, and ground-truth annotations are freely released to facilitate open science and reproducible research.

Metabolic discrimination of Thymus, Zataria, and Ziziphora genera by NMR-based metabolomics

Thyme is a commercial spice widely used in food, cosmetics, and pharmaceutical industries. Three popular genera in food and traditional medicine, including Zataria Boiss., Thymus L., and Ziziphora L., are considered as thyme-like plants in Iran. Thyme has been standardised based on phenolic monoterpenes, which are abundant in the essential oils of these three genera. Apart from monoterpenes, the flavonoid naringenin, the triterpene oleanolic acid, and phytosterols such as β-sitosterol were abundant in Zataria, Thymus, and Ziziphora samples, respectively. Therefore, employing current analytical techniques on the basis of thymol and carvacrol may be insufficient to differentiate Thymus spp from similar medicinal plants including Zataria and Ziziphora spp. In this study, we applied NMR-based metabolomics using multivariate analyses to develop quality control of thyme and their similar products. Our findings revealed that NMR-based metabolomics can be a useful approach in differentiating Zataria, Thymus, and Ziziphora.

Shale gas play of the silurian hot shale, Ghadames Basin, North Africa: Insights from integrated geochemistry and basin modeling

The lower Silurian hot shale in the Ghadames Basin was investigated to provide a regional assessment of the future prospects of shale gas play as an important unconventional resource system in one of the top African superglobal petroliferous sedimentary basins. The unconventional natural gas potential of the hot shale was studied based on regional improved organofacies assessment, thermal maturity, the timing of generation and expulsion, and sweet gas spot analysis, such as gas in place (GIP), total expelled gas (TEG), and total retained gas (TRG). The integration between regional geology and organic geochemistry, together with the proper regional utilization of the multi-dimensional basin modeling to better appreciate the importance of the Silurian hot shale as a key future shale gas unconventional-rich petroleum system (URPS) in the Ghadames Basin. The relationship between the richness and thermal parameters, such as the total organic carbon indicator (%TOC), hydrogen index (HI), measured and time step (calibrated models) vitrinite and equivalent vitrinite (%VRo) reflectance were used to develop quality control models for the regional natural gas spots of the Silurian hot shale were present-day mapping presentations are utilized as well for each parameter to better appreciate the lateral variability of the dry gas volumes. Regional basin control parameters from several key wells, such as heat flow levels, formation pressure system, and basin porosity were successfully utilized for the hot shale gas play resource screening (sweet spots) study utilizing multi-dimensional modeling approaches. The established regional spatial type B marine organofacies of the hot shale with excellent geochemical properties (∼18 %TOC) and regionally sufficient thermal maturation (∼2.45 %VRo, post-mature stage) indicate a significant amount of natural gas expelled and retained that has occurred in the Silurian hot shale system. The estimated GIP of the hot shale is about 120 bcf/km2 (equivalent to 320 bcf/section). The maximum expelled gas (TEG) amount is defined with values up to 88 bcf/section and the total estimated volume of the retained gas (TRG) is up to 96 bcf/km2, with the current geological architecture, geochemical properties, volumes, and distribution of the hot shale dry gas sweet spot in the Ghadames Basin. The hot shale can be considered in the near future for extensive further studies and exploration and development plans in Libya, Algeria, or Tunisia.

Estimation of Quality, Safety and Efficacy of Ashwagandhadi Leha Using Chromatographic Technique

Ashwagandhadi leha falls under the category of avaleha-paka group of Ayurvedic formulations. If the raw material to be used in a formulation and routine checking stage by stage processes of manufacture are standardized, the resulted product can be expected to confirmed uniform standard, therefore present study envisaged to develop quality control parameters in order to evaluate the quality, safety and efficacy of the formulation (Ashwagandhadi leha).

Clinical pathway in Chinese county for lung cancer diagnosis and treatment (2023 edition)

Lung cancer (LC) is the leading cause of death among patients with cancer both in worldwide and China. China accounts for 11.4% of the total number of cancer cases and 18.0% of the total number of cancer deaths in the world. Standardizing the diagnosis and treatment of LC is a key measure to improve the survival rate of LC patients and reduce the mortality rate. However, county hospitals generally face the problem of inaccessibility to advanced diagnostic and treatment technologies. Therefore, when developing quality control standards and clinical diagnosis and treatment specifications, it is necessary to combine the actual situation of county hospitals and formulate specific recommendations. The recommendations of treatment measures also need to consider the approval status of indications and whether it is included in the National Reimbursement Drug List (NRDL), to ensure the access to medicines. In order to solve the above problems, based on existing guidelines at home and abroad and the clinical work characteristics of county hospitals, the first clinical pathway in Chinese county for LC diagnosis and treatment (2023 edition) was compiled. This pathway elaborated on the imaging diagnosis, pathological diagnosis, molecular testing, and precision medicine based on histological-pathological types, tumor-node-metastasis (TNM) classification, and molecular classification, developed different diagnosis and treatment processes for different types of LC patients. Simultaneously, according to the actual work situation of county hospitals, the diagnosis and treatment recommendations in clinical scenarios are divided into basic strategies and optional strategies for elaboration. The basic strategies are the standards that county hospitals must meet, while the optional strategies provide more choices for hospitals, which are convenient for county doctors to put into clinical practice. All the recommended diagnostic and treatment plans strictly refer to existing guidelines and consensus, ensuring the scientificity.

How can contamination be prevented during laboratory analysis of atmospheric samples for microplastics?

Microplastics (MPs) in the air and indoor environments are of growing concern and have led to increased testing for MPs. This study draws attention to the quality and quantitative measures of MP studies by conducting laboratory experiments (on solutions, filters, and blank samples) that were rarely or were not adopted in the airborne and indoor MP literature. Experiments have been conducted to identify contaminations that may come from experimental procedures while determining MPs in the air samples. MPs in different matrices during experiments were counted and categorized by their shapes. Chemical characterization was performed by Raman Spectroscopy. Results showed that laminar flow is the best option over a fume hood or standard laboratory environment for detecting air MPs to reduce blank levels. Blue-green and Black-Grey were the dominant colors; fiber was the predominant type of MPs seen, and most of them fall under the size range from (1-1000µm) in different indoor environments and blanks. Common MPs seen were PP, PVA, PTFE, PVC, and HDPE. Thermal treatment of fresh unused filters at 450°C for 4h was effective as it reduced the MP count by 50%. Working solutions are mainly contaminated, and their pre-filtration is essential. The average deposition of MPs in blank samples during seven days was around 55 MPs. There is an urgent need for studies on developing quality control and quality assurance of airborne and indoor MPs. Hence, a standard protocol needs to be accepted; by harmonizing procedures, comparable results can be found, uncovering the correct levels of MP contamination, as required for risk assessment.

A comprehensive method for quality evaluation of Tibetan medicine Synotis solidaginea by integrating UHPLC-Q-Orbitrap MS chemical profiling and UHPLC-DAD multi-components quantification

Synotis solidaginea Hand.-Mazz. (SSD) is a commonly used Tibetan medicinal herb with a long history of therapeutic use and has good medicinal value and development and utilization prospects. This study aimed to establish and validate a comprehensive strategy integrating UHPLC-Q Exactive Orbitrap HRMS chemical profiling and UHPLC-DAD multi-components quantification for the holistic quality evaluation of SSD. Using UHPLC-Q Exactive Orbitrap HRMS, a total of 58 components in SSD including flavonoids, organic acids, terpenoids, coumarin, and alkaloids were identified or tentatively characterized by authentic reference standards and accurate masses and characteristic fragment ions. The proportion of flavonoids and organic acids were the most in SSD. Subsequently, 7 characteristic components in SSD were quantified by a newly established UHPLC-DAD method that was validated in terms of linearity and ranges, LOD and LOQ, precision, repeatability, stability, and accuracy. Finally, the method was successfully used for the quality evaluation of 8 batches of SSD collected from 5 production areas in China. ANOVA and post hoc Tukey test are used to evaluate the differences in component content in SSD from different production areas. There are significant differences in the content of SSD from different regions (P < 0.05), which may be related to the climate, altitude, and other natural environments of the regions. This work laid a valuable foundation for further development and comprehensive quality control of SSD.

A U.S. Pharmacopeia (USP) overview of Pan American botanicals used in dietary supplements and herbal medicines.

The United States Pharmacopeial Convention (USP) is a nonprofit, scientific, standard-setting organization, and world leader in establishing quality, purity, and testing standards for medicines, foods, and dietary supplements. USP quality standards are used in more than 140 countries and are legally recognized by more than 40 countries. Currently, there is renewed interest in herbal medicines globally, and health policies are being implemented worldwide for the use of complementary and traditional medicine. In response, USP has developed a robust body of monographs that can be used to guide industry and regulators in ensuring the quality and safety of botanical ingredients used in dietary supplements and herbal medicines. Throughout the Pan American regions, there is a strong tradition of using botanicals as herbal medicines and, as in other regions, a growing desire for botanical dietary supplements. This underscores the need for public quality standards to ensure quality, reduce the flow of substandard and adulterated products, and ensure public health and safety. In April 2022, USP launched the Pan America Botanical Dietary Supplements and Herbal Medicines Expert Panel, with experts representing 12 different countries. The Expert Panel's work focuses on developing quality control standards for the most important botanical ingredients used in the respective countries, ingredients that are also of global importance. This article provides an overview of the state of botanical dietary supplements and herbal medicines in different Pan American regions with a focus on the regulatory status of herbal products, the development of national quality and research initiatives, and policies related to agriculture conservation and sustainability, among other topics.

An example of one health approach: a timeline of the history of trichinellosis control

Trichinellosis is the first zoonosis for which a detection at the slaughterhouse is mandatory. The delay between the description of the parasite in 1835 (Owen and Paget), first finding in pork in 1846 (Leidy), deciphering of the cycle in 1858 (Virchow), its demonstration as a pathogenic agent in 1860 (Zenker), and the implementation of a control in pork in the duchy of Brunswick (Germany) in 1863 was rather short. This control led to a dramatic decrease in lethal cases in Germany. Around 1880, most European countries claimed that massive importations of pork from the USA could be sources of trichinellosis. Therefore, the USA was obliged to check on an industrial scale that all exported pork was Trichinella free. In the 20th century, several institutions played a crucial role in the control of trichinellosis: the USDA in Beltsville (deep-freezing killing of larvae, controls in farms, digestion techniques and antigenic preparations), the RIVM in Bilthoven (ELISA), the ISS in Rome (clarification of the different species of Trichinella. The ANSES (Maisons-Alfort, France) performed horse experimental infections and, with the CFIA (Saskatoon, Canada) developed quality control assurance, proficiency samples, and technician training". The International Commission on Trichinellosis (ITC) (created in 1960) was a key tool to develop collaborations and issue recommendations on control and Trichinella-free farming.

Proteome Analysis of the ROF-FKBP Mutants Reveals Functional Relations among Heat Stress Responses, Plant Development, and Protein Quality Control during Heat Acclimation in Arabidopsis thaliana.

In the present study, a differential screening following heat stress acclimation was performed in Arabidopsis thaliana WT and ROF-FKBP mutated plants using mass spectrometry, and the results were used to understand and analyze the effect of the ROF PPIases during thermotolerance acquisition in plants. Our data highlight the central role of these two PPIases in heat stress and point to their direct or indirect effect on other proteins participating in cellular functions such as protein folding and quality control, cell division, photosynthesis, and other metabolic and signaling processes. Specifically, the heat stress response, protein folding, and protein ER processing pathways are enhanced following a 37 °C acclimation period independent of the mutation state. However, at 37 °C, and in the double-mutated rof1-/2- plants, a higher accumulation of proteins belonging to the above pathways is observed compared with all other conditions (WT, single mutants, control, and heat-acclimated plants). Furthermore, the proteasomal pathway, involving the common member of both the protasomal and the lysosomal degradation pathway, CDC48, is over-represented in the extracts of both the untreated and heat-stressed rof1-/2- mutants compared with the other extracts. In contrast, in the single rof1- mutation, the heat acclimation pathway is suppressed at 37 °C when compared to the WT. Protein accumulation related to the heat stress and the protein quality control pathways points to a differential but also synergistic role of the two proteins. Protein complexes of other biochemical and developmental mechanisms, such as the light-harvesting complex of the photosynthetic pathway and the phosphoinositide binding proteins involved in membrane-trafficking events during cell plate formation and cytokinesis (patellin 1, 2, and 4), are negatively regulated in the rof1-/2- mutant. Our results suggest that ROF1 and ROF2 FKBPs regulate stress response, and developmental and metabolic pathways via a complex feedback mechanism involving partners that ensure protein quality control and plant survival during heat stress.

Quality Evaluation of Gentamicin Sulfate Reference Standards in Japanese Pharmacopoeia Using Hydrophilic Interaction Chromatography Combined With Tandem Mass Spectrometry.

Through the recent development of analytical technology, antibiotics quantification in the Japanese Pharmacopoeia (JP) has changed from traditional microbiological assays to physicochemical methods with high specificity and precision. However, for several multicomponent antibiotics without typical UV absorption, potency cannot be directly determined using instrumental methods such as high-performance liquid chromatography; therefore, traditional microbiological assays are still used. Gentamicin sulfate (GmS), which consists of three major components, C1, C1a, and C2, is such a typical antibiotic, and its antimicrobial potency continues to be assayed using microbiological methods in JP monographs. Introduction of a physicochemical assay for GmS is needed to help ensure its quality and quantity. This study aimed to develop quality control measures for GmS that could be complementary to quantitative assays and purity tests specified in the JP. For each gentamicin C component (C1, C2, and C1a), theoretical potencies were determined based on the quantitative relationship between purity and potency, as measured by quantitative 1H NMR and microbiological assays, respectively. Two lots of the JP reference standard (RS) were used as test samples, with the contents of each component and impurity (sisomicin and garamine) being determined using hydrophilic interaction liquid chromatography-tandem mass spectrometry (HILIC-MS/MS). The ratios of theoretical potency for C1, C2, and C1a were 1.00, 1.21, and 1.80, respectively. The potencies of the GmS JP RSs, which were estimated based on the contents and theoretical potency of each C component, corresponded well with those determined through microbiological assays. Marked differences in impurities (%) between the two RS lots were highlighted by quantifying sisomicin and garamine. The developed analytical procedure enabled the characterization of two different JP RSs in terms of content ratio, potencies, and impurities. Novel analytical procedures useful for routine quality control of GmS were developed using HILIC-MS/MS.

The Dimensional Effect of Optimal Project Risk Management Practices on Project Quality of Selected Construction Companies in Nigeria

In the construction industry, ensuring high-quality standards is a critical aspect of construction projects and plays a pivotal role in the sustained viability and triumph of contemporary construction companies. However, existing literature highlights the persistently subpar levels of project quality within the construction sector. This situation is manifested through cost overruns, time delays, deficient project definition, and fluctuations in project scope, which are indicative of insufficient project risk management practices. Although several studies have examined project risk management practices, little emphasis has been placed on evaluating their impact on quality in the construction industry. Hence, this study examined the dimensional effect of optimal project risk management practices on project quality of selected construction companies in Nigeria. Survey research design was adopted. The population was 202 top management and mechanical department staff of three selected construction companies in Lagos State, Rivers State, and the Federal Capital Territory of Abuja, Nigeria. A sample size of 176 was found to be usable. A validated questionnaire was adopted for data collection. Cronbach’s alpha reliability coefficients for the constructs ranged from 0.74 to 0.98. The response rate was 87.1%. Data were analyzed using the Smart partial least squares structural equation modeling (PLS-SEM) software, which allowed for the testing of path analysis and hypotheses. A confirmatory factor analysis (CFA) was employed to assess the factor loading of the variables. Findings indicated that project risk management practices had significant effect on project quality of selected construction companies in Nigeria (Adj R2 = 0.54, F2 = 0.058, Q2 = 0.507, p &lt; 0.05). The study concluded that project risk management practices improved the quality of the selected construction companies in Nigeria. The study recommended that project managers should establish and implement effective quality management systems that outline clear processes and procedures for ensuring project quality. Develop quality control plans that include inspection, testing, and monitoring activities throughout the project lifecycle. Incorporate quality management standards and best practices, such as ISO 9001, to enhance quality assurance processes.

Correlation of Energy Density and Manufacturing Variables of AA6061 through Laser Powder Bed Fusion and Its Effect on the Densification Mechanism

Aluminum alloy processing via additive manufacturing (AM) technologies has increased in usage during the last decade. AM now enables manufacturing complex geometries not previously achieved through traditional manufacturing. Aluminum is usually processed using laser powder bed fusion (LPBF) technologies, which are used to manufacture metallic components of high geometrical complexity and dimensional accuracy and good mechanical, electrical, and chemical properties, which is why this technology is quite popular at industrial levels. To further develop quality control systems and new aluminum alloys using LPBF, there is a need to establish a predictive relationship between the parameters of the material. A study was carried out to investigate the relationship between energy density and process parameters such as laser power, scan speed, hatch spacing, scan pattern, and laser focus and its influence on the densification mechanism in additively manufactured components with aluminum alloys. AA6061 was selected due to its wide usage in different industries, given its low density and high mechanical performance. Relative density was analyzed using the Archimedes principle, and the quality and morphology of the AA6061 powder were analyzed through metallographic analysis. The process parameter selection was performed according to the best results obtained according to the laser power and energy density factors. The best manufactured samples had an energy density between 30 and 40 J/mm3, with relative densities above 99%.

Identification of adulteration in the market samples of saffron using morphology, HPLC, HPTLC, and DNA barcoding methods.

Saffron, the stigma of Crocus sativus L., is the most expensive spice used for culinary, medicinal, dye, and cosmetics purposes. It is highly adulterated because of its limited production and high commercial value. In this study, 104 saffron market samples collected from 16 countries were tested using morphology, high-performance liquid chromatography (HPLC), high-performance thin-layer chromatography (HPTLC), and deoxyribonucleic acid (DNA) barcoding. Overall, 45 samples (43%) were adulterated. DNA barcoding identified the highest number of adulterated saffron (44 samples), followed by HPTLC (39 samples), HPLC (38 samples), and morphology (32 samples). Only DNA barcoding identified the adulterated samples containing saffron and other plants' parts as bulking agents. In addition, DNA barcoding identified 20 adulterant plant species, which will help develop quality control methods and market surveillance. Some of the adulterant plants are unsafe for human consumption. The HPLC method helped identify the saffron samples adulterated with synthetic safranal. HPLC and HPTLC methods will help identify the samples adulterated with other parts of the saffron plant (auto-adulteration).