Quality Risk Assessment Research Articles

Misjudging drinking water quality risk: Adopting a barrier approach for meaningful risk assessment to address latent risks.

The water quality risk assessment is the foundation for every drinking Water Safety Plan. The need to conform with a 'Corporate' risk assessment model commonly dominated by asset management frequency data can cause misjudgement of microbial risk. Well-performed risk assessments should identify potential risks. Risk assessments which place too much emphasis on historical evidence to demonstrate 'likelihood' of microbial contamination are unsuitable for drinking water quality because they fail to recognise 'latent' risks associated with absent or underperforming barriers to contamination. Most outbreaks occur when these 'latent' factors align to create a failure. Good risk assessments need to provide foresight. This is achieved if drinking water quality risk assessments are based on a 'barrier' approach. Where adequate and reliable multiple barriers to contamination are present the likelihood of a hazardous event should then be categorised as rare. Where barriers are absent, inadequate, or unreliable, then a higher likelihood is appropriate, depending on the nature and extent of the barrier shortfall. Practical examples show how the 'barrier' approach can be applied. The barrier risk assessment directly informs the operational monitoring programme, enabling regular confirmation that the challenge and barrier performance are consistent with the predictions of the risk assessment.

Evaluation of groundwater quality and health risk assessment in southeastern Tibet, China

Evaluation of groundwater quality and health risk assessment in southeastern Tibet, China

Pesticides, Heavy Metals and Plasticizers: Contamination and Risk Assessment of Drinking-Water Quality

This study highlights the impact of formal agricultural practices and their adverse effect on the deterioration of underground water quality, with special emphasis on toxic elements, including pesticides, herbicides, fungicides, plasticizer accumulation and heavy-metal contamination. A comprehensive study was conducted at various recently developed societies of Sadiqabad that were formerly used for agricultural purposes. Ten various societies were selected, and three samples from each society were collected from different regions of these areas. Data regarding the physicochemical properties, metal contamination and accumulation of pesticide residues were determined using standard protocols. The results revealed that almost all the physicochemical properties of water samples selected from these sites were close to the WHO’s recommended limits. The range for physicochemical properties was pH (6.4–7.7), electrical conductivity (168–766 µ S cm−1), turbidity (6–17 NTU), total hardness (218–1030 mg L−1), chloride contents (130–870 mg L−1) and phosphate contents (2.55–5.11 mg L−1). Among heavy metals, lead and arsenic concentrations in all sampling sites were found to be above the recommended limits. The decreasing pattern in terms of water-quality deterioration with respect to physicochemical properties was FFT > USM > CRH > UCS > CHS > MAH > FFC > CGA > GIH > AGS. Overall, 95 different kinds of toxic elements, including pesticides, herbicides, plasticizer, etc., were detected in the groundwater samples. The toxic compounds in the groundwater were categorized into pesticides, herbicides, plasticizer, plant growth regulators, fungicides, acaricides and insecticides. Most of these parameters showed peak values at the Fatima Fertilizer Company area and Chief Residencia Housing Society. Pesticide contamination showed that water-filtration plants have a big positive impact on the drinking quality of water. Proper monitoring of the pesticides must be performed, as the majority of the pesticides showed low priority. The monitoring method of the pesticides needs to be updated so that the occurrence of recently authorized pesticides is demonstrated.

Groundwater Quality, Hydrogeochemical Characteristics, and Potential Health Risk Assessment in the Bhubaneswar City of Eastern India

Groundwater Quality, Hydrogeochemical Characteristics, and Potential Health Risk Assessment in the Bhubaneswar City of Eastern India

The Quality Risk Assessment of Paralithodes Camtschaticus Collagenase Gel in the Process of Pharmaceutical Development

Introduction. The manufacturing and application of enzyme preparations in the semisolid topical products has features associated with their lability. In previous studies, on the set of specifications the gel form was selected, containing aerosil and olive oil, in which the stabilization of collagenase from Paralithodes camtschaticus was ensured by lipophilic base. In the pharmaceutical development process, the drug critical quality attributes must be defined. Taking into account the lability of Paralithodes camtschaticus collagenase, the identification and minimizing risks аre relevant.Aim. The aim was the risk factors assessment and minimization during the pharmaceutical development of the gel, containing Paralithodes camtschaticus collagenase within the QbD concept.Materials and methods. The laboratory samples of gels, containing Paralithodes camtschaticus collagenase, were tested, using the analysis methods recommended by the SP RF 14th ed., as well as GOST 29188.3-91.Results and discussion. Based on the potential critical characteristics of the material, the pharmaceutical substance Paralithodes camtschaticus collagenase (particle size) and excipients (concentration and sorption properties of aerosil, oxidation of olive oil) risk factors were assessed, and potential measures to reduce these risks are considered. It was revealed that the substance particle size in its origin exceeds the norm and requires preliminary grinding. The aerosil content factor was reveal as critical. The sorption properties of aerosil were not affected the proteolytic and collagenolytic activity of the collgenase gel. It was proved that chemical instability of oil refers to critical factors and the antioxidants (alpha-tocopherol or butylhydroxytoluene) content was justified.Conclusion. In the course of the study, the Paralithodes camtschaticus collagenase gel the possible risks of pharmaceutical substances and excipients were theoretically justified in accordance with the QbD concept. An experimental assessment of their possible impact on the gel quality was given, which can improve the finished product quality during manufacturing manufacturing by eliminating the identified risks.

Variation in Polycyclic Aromatic Compound (PAC) Concentrations in a Norway Spruce Stand Close to a Major Traffic Route—Influence of Distance and Season

Air concentrations of polycyclic aromatic compounds (PACs) were measured in a Norway spruce (Picea abies) stand at four different distances from a major traffic route near Gothenburg, Sweden, during summer and winter 2019, using passive samplers. In total, the concentrations of 32 polycyclic aromatic hydrocarbons (PAHs) and six dibenzothiophenes (DBTs) and NO2 were analysed. PAC air concentrations were on average 2.5 times higher during the winter compared to the summer. All investigated PAH categories and compounds as well as dibenzothiophene declined linearly with the logarithmic distance from the traffic route. This indicates that the length of pollutant pathways through vegetation is a valid proxy to assess health risks of traffic-related PAC pollutants. Concentrations of heavier PAHs declined faster (concentration at site furthest away from the road was 6% and 33% of concentration at site closest to road, for summer and winter respectively) with increasing distance from traffic compared to lighter PAHs (63% and 68% for summer and winter respectively). As a result, the mix of PAHs changed with the depth into the forest stand (i.e. distance from the road) with potential effects on the toxicity as well as on diagnostic ratios used for source attribution. This is likely caused by different deposition rates among the PAH compounds to the vegetation surfaces, although the exact mechanism needs to be further investigated. This study provides new information that can improve air quality risk assessment and limit the exposure of the population to toxic air pollutants such as PACs.

Identification of the Groundwater Quality and Potential Noncarcinogenic Health Risk Assessment of Nitrate in the Groundwater of El Milia Plain, Kebir Rhumel Basin, Algeria

In this study, we analyzed the quality and the potential noncarcinogenic health risk of nitrate in groundwater in the El Milia plain, Kebir Rhumel Basin, Algeria. Moran’s I and the ordinary kriging (OK) interpolation technique were used to examine the spatial distribution pattern of the hydrochemical parameters in the groundwater. It was found that the hydrochemical parameters Ca, Cl, and HCO3 showed strong spatial autocorrelation in the El Milia plain, indicating a spatial dependence and clustering of these parameters in the groundwater. The groundwater quality was evaluated using the entropy water quality index (EWQI). The results showed that approximately 86% of the total groundwater samples in the study area fall within the moderate groundwater quality category. The spatial map of the EWQI values indicated an increasing trend from the south-west to the northeast, following the direction of groundwater flow. The highest EWQI values were observed near El Milia city in the center of the plain. This spatial pattern suggests variations in groundwater quality across the study area, with potentially higher risks near the city center. The potential noncarcinogenic health risks associated with nitrate contamination in groundwater for adults and children through the drinking water pathway were assessed using the hazard quotient (HQ). The results revealed that approximately 5.7% of the total groundwater samples exceeded the HQ limit for adults, indicating potential health risks. Moreover, a higher percentage, 14.28%, of the total groundwater samples exceeded the HQ limit for children, highlighting their increased vulnerability to noncarcinogenic health hazards associated with nitrate contamination in the study area. Taking timely action and ensuring strict compliance with regulations in groundwater management are crucial for protecting public health, preserving the environment, addressing water scarcity, and achieving sustainable development goals.

Water quality and health risk assessment of heavy metals in groundwater of Ranbir Singh Pura tehsil of Jammu and Kashmir, India.

Groundwater is one of the important sources available for drinking, agricultural, domestic, and various other purposes in the study area. Study area is having agricultural importance and is famous for Basmati rice production in the world. In order to assess water suitability for irrigation and drinking purposes, 25 sampling sites were selected and water samples were collected from handpumps, borewells and motors from May 2022 to June 2022. Fifteen physico-chemical parameters and water quality index (WQI) was calculated to assess the drinking water suitability. The results obtained then compared with the BIS (2012) and WHO drinking water guidelines. For irrigation water suitability, irrigation water quality index (IWQI) and other indices were calculated. Heavy metal health risk assessment was also evaluated using target hazard quotient (THQ), carcinogenic risks (CR), non-carcinogenic risks, heavy metal pollution index (HPI), etc. Study found 60% of water samples under poor category of WQI. All water samples were found suitable for irrigation purposes according to different indices except for permeability index for which only 32% samples were found suitable. IWQI classifies 52%, 32%, and 12% of water samples under moderate, low, and no restriction category respectively. Groundwater of the study area found to be contaminated with copper (Cu), iron (Fe), lead (Pb), and chromium (Cr) while low contamination of zinc (Zn) and arsenic (As) was found according to heavy metal evaluation index (HEI). High contamination of chromium (HPI= 9740.8) and lead (HPI=188) was recorded as per HPI. HQ value for men, women, and children in case of zinc were found safe while HQ values for copper and lead in all population groups were found at risk. Overall, the study area was found highly contaminated with the lead, copper, and chromium concentrations. Thus, study recommends regular monitoring of the groundwater of study area as well as treatment before using this water for drinking purposes.

Water quality and health risk assessment in the Gandaki river basin, central Himalaya, Nepal

Public health is at threat due to chemical contaminants in drinking water which may have direct health concerns. The suitability of water for health is primarily governed by the mineral constituents present in the water. The present study was carried out to evaluate the water quality and associated health risks in the Gandaki River Basin (GRB) in Central Himalaya, Nepal considering hydrochemical variables such as total dissolved solids (TDS); major cations (Ca2+, Mg2+, K+, and Na+); major anions (Cl-, NO3-, SO42-, and HCO3-) and trace metals (As, Cu, Mn, Ni, Pb, Zn, Ba, Cr, Li and Sr) in spatiotemporal levels. Water Quality Index (WQI), Health Risk Assessment (HRA), and Cancer Index (CI) were analyzed to evaluate the overall quality of water in the GRB. The results revealed that all the examined variables were within the National Guidelines recommended for domestic uses. Moreover, the results revealed that concentrations of TDS, major ions, and trace metals showed significant seasonality and the WQI values were found to be 36.38, 23.77, and 30.36 in pre-monsoon, monsoon, and post-monsoon, respectively indicating better water quality in the monsoon season. Additionally, CI analysis of the selected trace metals such as As, Cr and Pb indicated relatively low cancer risk in the river water during all the seasons. The hazard quotient (HQ) dermal values of all the elements were < 1, signifying the little or no adverse effects via a dermal path, while HQ ingestion values of Ba, Li, Sr, and Zn were found to be >1 during all the seasons indicating their possible threat via ingestion path. This study provides a useful database and suggests regular assessment and, also appropriate policy formulations for safeguarding the water bodies in the Himalayas.

Analytical Quality Risk Assessment and Design of Experiments to Green HPTLC Method for Simultaneous Estimation of Sildenafil Citrate and Dapoxetine Hydrochloride.

A green and robust high-performance thin-layer chromatographic method has been developed for the simultaneous estimation of sildenafil citrate and dapoxetine hydrochloride. A fractional factorial design was applied for analytical quality risk assessment of potential analytical risk factors. The identified critical analytical risk factors were optimized using the design of experiment-based response surface analysis by full factorial design. The analytical design space was navigated for the optimization of the method and the control strategy was framed for low-risk life-cycle management of the chromatographic method. The chromatographic analysis of sildenafil and dapoxetine was carried out on a TLC plate coated with silica gel G60 F254 using n-butanol:ethyl acetate:ethanol (8.0 + 2.0 + 0.5, v/v) as mobile phase. The chromatographic peaks of sildenafil and dapoxetine were found to be at Rf 0.29 and 0.69, respectively. The method was found to be accurate, precise, robust, specific and sensitive. The fixed-dose combinations of sildenafil and dapoxetine were assayed and results were found in compliance with their labeled claim. The present method was developed using safe and eco-friendly organic solvents for the safety of analysts and the protection of the environment. The greenness profiles of developed and reported methods were evaluated using the NEMI scale and AGREE software.

Biopharmaceutics Risk Assessment-Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions.

Quality risk assessment following ICH Q9 principles is an important activity to ensure optimal clinical efficacy and safety of a drug product. Typically, risk assessment is focused on product performance wherein critical material attributes, formulation variables, and process parameters are evaluated from a manufacturing perspective. Extending ICH Q9 principles to biopharmaceutics risk assessment to identify factors that can impact in vivo performance is an upcoming area. This is evident by recent regulatory trends wherein a new term critical bioavailability attributes (CBA) has been coined to identify such factors. Although significant work has been performed for biopharmaceutics risk assessment for new molecules, there is a need for harmonized biopharmaceutics risk assessment workflow for generic submissions. In this manuscript, we attempted to provide a framework for performing biopharmaceutics risk assessment for generic regulatory submissions. A detailed workflow for performing biopharmaceutics risk assessment includes identification of initial CBA (iCBA), their confirmatory evaluation followed by definition of the control strategy. Tools for biopharmaceutics risk assessment, i.e., bio-discriminatory dissolution method and physiologically based biopharmaceutics modeling (PBBM) were discussed from a practical perspective. Furthermore, a case study for CBA evaluation using PBBM modeling for an extended-release product for regulatory submission has been described using the proposed workflow. Finally, future directions of integrating CBA evaluation, biopharmaceutics risk assessment to the FDA Knowledge Aided Structured Assessment (KASA) initiative, the necessity of risk assessment templates, and knowledge sharing between industry and academia are discussed. Overall, the work described in this manuscript can facilitate and provide guidance for biopharmaceutics risk assessment for generic submissions.

Assessment of Habitat Risks Caused by Human Activities and Integrated Approach to Marine Spatial Planning: The Case of Sriracha District—Sichang Island

According to the Thailand’s National Strategy (2017-2036) and National Reform Plans, various tools, techniques, or methods are necessary to collect and investigate data for the effective preservation and protection of the country’s natural resources. We aimed to apply various tools and methods for integrated coastal management in Thailand. This study used the InVEST models, including the habitat quality (HQ) and habitat risk assessment (HRA) models, to evaluate the natural habitat quality and cumulative human activity risk in the Sriracha district and Sichang Islands, Thailand. The HQ model revealed the presence of abundant ecological services and high quality natural habitats. We observed habitat degradation in the mooring zone, city area, forests, and coral reefs, with moderate risk to distinct habitats. Our findings identified two potential scenarios. Conservation scenarios exhibited a lower HRA ratio compared to current and development scenarios. Overall, the results showed the effectiveness of the InVEST model in evaluating habitat risk under both present and simulated conditions. Our study highlights the importance of informed management plans and policy-making processes to achieve planned coastal management goals.

Appraising groundwater quality and the associated health risks of heavy metal contamination at Suame magazine

Suame magazine is well-known as one of the largest artisanal sites in Ghana, for which metal fabrication, vehicle repairs, and sales of spare parts are the hallmarks. Despite the increased risk of heavy metal pollution, quality of the ground water as well as the risk implications to human remains vague. Towards this shed, the present study seeks to investigate the extent of heavy metals pollution of groundwater; and the possible health risk they pose to consumers. A total of 15 groundwater samples were sampled from different boreholes and were analysed for Cd, Cr, As, Zn, Pb, and Cu concentrations. Water quality and health risk assessment indices were employed to evaluate the suitability of the water for domestic purposes. The results showed that concentrations “Cd (0.12 mg/L± 0.08) and Cr 0.11 mg/L± 0.09)” exceeded their respective standards, 0.003 mg/L and 0.05 mg/L according to the WHO recommended levels for drinking water. In addition, water quality index rated the groundwater as unfit (WQI >300) for drinking purposes. Results of health risk indices showed that ingestion of ground water could pose cancer and non-cancer risk for elements of As, Cd, and Cr to both children and adults. Noteworthily, children are at a higher risk to non-carcinogenic effects, whilst adults are relatively susceptible to carcinogenic risk. Our findings provided a scientific basis for strategies to protect human and environmental health of artisanal-based communities in Ghana.

Spatial variation in groundwater quality and health risk assessment for fluoride and nitrate in Chhotanagpur Plateau, India.

The evaluation of groundwater quality is vital to assess the risk to human health. The present study assesses groundwater quality for drinking purposes and human health risks due to ingestion of fluoride and nitrate through drinking water in Chhotanagpur Plateau, India, using geoinformation techniques. For drinking water quality assessment, analyzed parameters were compared with World Health Organization (WHO) standards, and water quality index (WQI) was used. Results reveal that most of the samples come within the desired limit suggested by WHO. In a few samples, conductivity, hardness, chloride, sulfate, and calcium are higher than the desirable limit, whereas fluoride and nitrate are beyond the permissible limit in 70% and 27% of the samples, respectively. WQI highlights that poor to very poor water is present in 25% of the samples. Anthropogenic activities have played a critical role in deteriorating groundwater quality, resulting in harmful impacts on human health. To assess non-carcinogenic health risks, the hazard quotient (HQ) and total hazard index (THI) were computed. THI ranges from 0.01 to 7.46, 0.01 to 7.05, and 0.01 to 9.05 for males, females, and children, respectively. THI is greater than the allowable limit in 84%, 78%, and 89% of the samples for males, females, and children, respectively, indicating high risk to human health, particularly children. The study advocates properwater management strategies. Knowledge of spatial variation and anomalous concentration is vital for groundwater management as well as health risk assessment. The findings of this study will be helpful to government officials, policy planners, and local communities.

Effectiveness of crisis resolution and home treatment teams in mental health crisis: a systematic review protocol

Background: People with mental health crises may need intensive care support that, in many countries, implies a psychiatric hospitalization that may negatively affect the individual. Furthermore, it involves the individuals’ removal from their daily spaces, which implies an adaptive effort when returning to the community. In order to reduce the treatment’s impact of a mental health crisis, Crisis Resolution or Home Treatment (CRHT) Teams have been providing an alternative to inpatient treatment. Aim: To analyze and highlight CRHT teams’ effectiveness in reducing days of treatment, relapse, and rehospitalization of adults (18-65 years) compared to treatment as usual defined as inpatient treatment. Methods: We will develop a systematic review of the current literature by the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2019 Statement. Two authors will independently conduct study inclusion, data extraction, quality, and bias risk assessments. We will include experimental study designs like randomized clinical trials, non-randomized, quasi-experimental, before and after studies, prospective and retrospective cohort studies, and case-control studies involving working-age adults (18-65 years) irrespective of culture, ethnicity, or mental health diagnosis. Results: We will include primary outcomes like days of treatment, relapse (as defined by each study), and rehospitalization. Secondary outcomes will be service user satisfaction, dropout rate, and the proportion of patients with adverse events (suicide, self-harm, or aggression/violence). Conclusions: This study will allow evidence to determine the need to create and encourage the implementation of CRHT teams to provide an effective alternative response to psychiatric hospitalization.

Quality risk assessment on traditional immunity booster plants cultivators in Punjab, India

Quality risk assessment on traditional immunity booster plants cultivators in Punjab, India

ОБГРУНТУВАННЯ БІЗНЕС ПРОЄКТУ СТВОРЕННЯ ІТ-ПРОДУКТУ В СФЕРІ РАЦІОНАЛЬНОГО ПОВОДЖЕННЯ З ПОБУТОВИМИ ВІДХОДАМИ

The article highlights the problems of irrational household waste management at the state level and substantiates the feasibility of using information support for the implementation of household waste sorting and recycling projects. The theoretical foundations for the development and implementation of sustainable household waste management projects are analyzed on the example of Germany, Poland, and Switzerland. An analysis of information development projects is carried out and an overview of the methodological foundations of effective practices for household waste management in an environmentally friendly manner and the use of secondary materials, which are key elements of EU environmental policy, is presented. The achievements of Ukrainian startups aimed at creating an appropriate ecosystem for waste sorting are identified. The role of the state in creating uniform rules for the rational management of household waste is analyzed in detail. The development of approaches to choosing a way to motivate stakeholders to manage household waste rationally through the creation of a digital platform for stakeholder interaction is demonstrated. A project for the development of a mobile application is proposed, which is an appropriate digital environment for motivating all stakeholders to sort waste. The application allows citizens to communicate with businesses and vice versa, under the supervision of public organizations in the legal field created by the state. The main stages of project creation are identified. The principles for forming a team and project budget are substantiated. The measures of quality assurance and risk assessment of the project are developed.

Assessment of air quality and community health risks in Di An city - Binh Duong province

Based on research methods such as data collection and processing, air quality index calculation methods, and public health risk assessment methods to assess air quality and effects of substances on the health of people in Di An city. The data for the calculation are inherited from the environmental monitoring report of the Department of Natural Resources and Environment of Di An City in the period of 2019. The calculation results show that the air quality in the city is. Di An is fluctuating at an average-poor level (especially in the Cay Lon junction area with the highest index of 150), the health risk assessment results show that when exposed to dust, the total group of people Adults (Women and Men) had a high fluctuating cancer risk index with the highest index of 2 subjects being in the first quarter 0.310, 0.295, in the second quarter 0.269, 0.282, in the third quarter 0.296, 0.282, Fourth quarter 0.289, 0.275. As for other indicators, the subjects assessed when exposed to substances in the air environment in Di An city can be affected their health, of which the group of adults is still the group of people. Women and men) are the most affected group.

Exploring hazard quotient, cancer risk, and health risks of toxic metals of the Mehmood Booti and Lakhodair landfill groundwaters, Pakistan

Landfill sites are the most common types of polluted land as they contaminate the environment badly. Environmental management of polluted sites can only be efficiently done with an integrated risk assessment. Previous studies reveal the need for more scientific literature comparing groundwater quality and health risk assessment of landfill sites of Lahore. The present study aimed to investigate the heavy metal concentration in groundwater and to evaluate the health risk assessment of the population residing near these two landfill sites. Mehmood Booti dumping site and the Lakhodeir landfill site were selected for the study. Groundwater samples (n = 15) were collected within 1500 m from each landfill site and analyzed for heavy metals to estimate the risk. Heavy metal analysis exhibited that in the Mehmood Booti landfill site, Cd, Pb, Ni, and Zn exceeded the permissible limit of the “World Health Organization” In the Lakhodair landfill site, Cd, Ni and Zn were above the permissible limits. Risk assessment results demonstrated that heavy metals pose carcinogenic risks to humans. The health risk assessment results revealed that 35% of respondents from the Mehmood Booti landfill site and 15% from the Lakhodair landfill site confirmed a serious ecological risk to their health. The Mehmood Booti landfill site is a prospective source of noxious contaminants pollution to the nearby population compared to the lakhodair landfill site. This study may repeatedly replicate the risk estimation of other contaminated lands in a cost-effective, consistent, and cohesive manner.

Health risk assessment of indoor air quality, sociodemographic and kitchen characteristics on respiratory health among women responsible for cooking in urban settings of Oromia region, Ethiopia: a community-based cross-sectional study

ObjectivesIn Ethiopia, where biomass fuel is used by the majority of the population, women who are primarily responsible for cooking are at a higher risk of having respiratory symptoms. However,...