Quality Control Practices Research Articles

Strengthening evidence-based medicine with real-world evidence

People conducting clinical trials often express concerns that real-world evidence is not reliable enough to form a basis for conclusions about causal relationships, because treatments are neither randomised nor blinded, and real-world data are not subject to the rigorous quality control practices used in randomised controlled trials (RCTs).1 Yet real-world data often are the only source for information about treatment outcomes for patients with complications or other vulnerabilities, such as a high-risk family history, lifestyle factors, limited access to health care, and economic hardship.

Market survey of disposable e-cigarette nicotine content and e-liquid volume

Inaccurate labels on some e-cigarette products have prompted calls for routine testing to monitor product label integrity. The objective of this study was to compare label statements of commercial disposable/non-chargeable e-cigarette products for nicotine concentration and e-liquid volume with analytically verified levels. Commercial e-cigarette samples were analyzed for nicotine concentration (N = 51), e-liquid volume and total nicotine content (N = 39). Twenty-three of the 51 samples analyzed for nicotine deviated from their label statements by more than ± 10%. Deviations ranged from -50.1% to + 13.9%. Thirty of the 39 samples analyzed for e-liquid volume deviated from their label statements by more than ± 10%. Deviations ranged from -62.1% to + 13.3%. Only one brand listed total nicotine on the label. In thirty-one of the 39 samples, calculated total nicotine amount in e-liquid deviated from the amounts calculated from the label metrics by more than ± 10%. Deviations ranged from -66.8% to -1.43%. These findings underscore the need for regulatory enforcement of manufacturing quality control and product labeling practices to optimize the harm reduction potential and consumer experience associated with the use of e-cigarette products.

FDA Warning Letters: A Retrospective Analysis of Letters Issued to Pharmaceutical Companies from 2010-2020.

PurposeTo launch a pharmaceutical product in the US market, approval from the FDA is required. Pharmaceutical companies undergo FDA pre-approval inspection (PAI for small molecule products) or pre-license approval (PLI for biological products) at their manufacturing sites (including contract development and manufacturing organization, testing laboratories, and packaging labelling facilities) prior to approval. After the products are approved by the FDA, surveillance inspections are performed by the FDA which are risk based as which company and which site will be inspected. The present study examines the causes of warning letters issued by the Center for Drug Evaluation and Research (CDER), FDA to the pharmaceutical companies after post-approval inspections.MethodsWarning letters issued from the time period 2010 to 2020 were obtained from the FDA website, and information about date of issuance, company, and type of violations was extracted for the study.ResultsPoor compliance to CGMP and misbranding were the most common reasons for the warning letters. Detailed analysis of CGMP warning letters elucidated three major types of violations, namely deficiencies in process validation, documentation practices (data integrity), and quality control corresponding to 26%, 21%, and 15% warning letters, respectively.ConclusionReview of the analysed letters demonstrates that the FDA’s major concern is over CGMP compliance. To avoid these warning letters, pharmaceutical manufacturers need to improve their quality compliance and focus on creating effective quality management systems that govern the entire manufacturing process, quality control, employee training, and documentation practice. Companies should develop an internal compliance check list and also be ready for corrective measures as and when required.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12247-022-09678-2.

Understanding data quality: Instructional comprehension as a practical metric in crowdsourced investigations of behavioral economic cigarette demand.

Crowdsourcing platforms allow researchers to quickly recruit and collect behavioral economic measures in substance-using populations, such as cigarette smokers. Despite the broad utility and flexibility, data quality issues have been an object of concern. In two separate studies recruiting cigarette smokers, we sought to investigate the association between a practical quality control measure (accuracy on an instruction quiz), on internal consistency of number of cigarettes smoked per day and purchasing patterns of tobacco products in an experimental tobacco marketplace (ETM; Study 1), and in a cigarette purchase task (CPT; Study 2). Participants (N = 312 in Study 1; N = 119 in Study 2) were recruited from Amazon mechanical turk. Both studies included task instructions, a quiz, a purchase task, cigarette usage and dependence questions, and demographics. The results show that participants who answered all instruction items correctly: (a) reported the number of cigarettes per day more consistently (partial η² = 0.11, p < .001, Study 1; partial η² = 0.09, p = .016, Study 2), (b) demonstrated increased model fit among the cigarette demand curves (partial η² = 0.23, p < .001, Study 1; partial η² = 0.08, p = .002, Study 2), and purchased tobacco products in the ETM more consistently with their current usage. We conclude that instruction quizzes before purchase tasks may be useful for researchers evaluating demand data. Instruction quizzes with multiple items may allow researchers to choose the level of data quality appropriate for their studies. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Standardization of the FAO/IAEA Flight Test for Quality Control of Sterile Mosquitoes.

Successful implementation of the sterile insect technique (SIT) against Aedes aegypti and Aedes albopictus relies on maintaining a consistent release of high-quality sterile males. Affordable, rapid, practical quality control tools based on the male’s flight ability (ability to escape from a flight device) may contribute to meeting this requirement. Therefore, this study aims to standardize the use of the original FAO/IAEA rapid quality control flight test device (FTD) (version 1.0), while improving handling conditions and reducing the device’s overall cost by assessing factors that could impact the subsequent flight ability of Aedes mosquitoes. The new FTD (version 1.1) is easier to use. The most important factors affecting escape rates were found to be tube color (or “shade”), the combined use of a lure and fan, mosquito species, and mosquito age and density (25; 50; 75; 100 males). Other factors measured but found to be less important were the duration of the test (30, 60, 90, 120 min), fan speed (normal 3000 rpm vs. high 6000 rpm), and mosquito strain origin. In addition, a cheaper version of the FTD (version 2.0) that holds eight individual tubes instead of 40 was designed and successfully validated against the new FTD (version 1.1). It was sensitive enough to distinguish between the effects of cold stress and high irradiation dose. Therefore, the eight-tube FTD may be used to assess Aedes’ flight ability. This study demonstrated that the new designs (versions 1.1 and 2.0) of the FTD could be used for standard routine quality assessments of Aedes mosquitoes required for an SIT and other male release-based programs.

Imputation of continuous missing values in profile data

AbstractProfile data have been widely used in quality control practice. However, in some applications, incomplete profiles, or profiles with continuous missing values, are frequently encountered. Imputation of continuous missing values in profiles for quality control is a challenging problem. In this work, we propose a latent feature model and a two‐step learning algorithm to reconstruct missing values. In the model, an unsupervised deep‐learning technique, variational autoencoder (VAE), is utilized to learn the latent features from profile data. Then a supervised variational coding (SVC) scheme is proposed to map the incomplete profile data to the learned latent features, and imputation is then made based on the latent features. The performance of the proposed method is evaluated by simulated and real datasets, and the results prove the effectiveness and superiority of the proposed method.

Sensory quality control: Assessment of food company employees' knowledge, attitudes, and practices

AbstractThis study was carried out to validate a questionnaire for assessing sensory quality control (SQC) knowledge, attitudes, and practices (KAP). The questionnaire, containing 24 knowledge, 13 attitudes, and nine practices items, was submitted to company representatives in South Africa and Nigeria. Confirmatory factor analysis and group comparisons among respondents and companies were carried out to validate the questionnaire. The final SQC‐KAP questionnaire consists of 24 knowledge (one scale), 11 attitudes (A bifactor scale, with a general scale and two subscales representing individual attitudes to SQC and those towards company SQC) and nine practices (one scale) items. The knowledge items had acceptable indices for difficulty and discrimination, and the attitudes and practices items had acceptable item‐total correlations. The final questionnaire can be used for the rapid assessment of SQC related knowledge and attitudes of food company employees and assessment of company practices.Practical ApplicationsThis study is the first to validate a questionnaire for assessing SQC related knowledge, attitudes, and practices in the food industry. The SQC‐KAP questionnaire can be used to rapidly assess SQC knowledge and attitudes of food company employees for sensory services, and to identify SQC training needs. Stakeholders can also use it to assess the sensory quality practices of food companies to gauge their compliance to good practice and identify potential areas of improvement of their SQC programs.

Principles of Manual Tissue Processing in an Oral and Maxillofacial Pathology Laboratory in Lagos, Nigeria

&#x0D; &#x0D; &#x0D; &#x0D; &#x0D; &#x0D; Introduction: Tissue processing describes the steps involved in infiltrating a well fixed tissue with wax for section cutting on a microtome. Paraffin tissue processing can be performed either manually or by using an automated tissue processor and errors in any of the steps involved would significantly affect histopathology. The aim of this article was to describe to principles of manual tissue processing as performed in the Oral and Maxillofacial Pathology Laboratory of the College of Medicine, University of Lagos, Nigeria (OMFP-CMUL Lab).&#x0D; Methods: We report the principles of manual tissue processing as performed in the OMFP-CMUL lab using the index case of an 11-year-old girl with a histopathologic diagnosis of unicystic ameloblastoma.&#x0D; Results: Steps of tissue processing included fixation, specimen accessioning, gross examination, decalcification (for tissue specimens containing calcium deposits), dehydration, clearing, infiltration, embedding, sectioning, labeling of tissue blocks, tissue floatation bathing, making the slide and numbering, staining, drying, cover-slipping, and microscopic examination.&#x0D; Discussion: Common errors seen in histopathology laboratories were avoided by the quality control practices of the residents, consultants, laboratory scientists and technicians within the department.&#x0D; Authors&#x0D; U P Egbunah 1, A O Akinshipo 2, O F Ajayi 2 3&#x0D; &#x0D;

Quality control test of fixed x-ray units at Bir hospital and National trauma center

One of the important goals of the use of X-rays is to diagnose a disease and its extent and minimizing the adverse effect. In diagnostic X-ray, there is an important issue concerning the quality of the image and the exposure of radiation to the patient. Regular practice of quality control in diagnostic X-ray is essential to provide good quality images, decrease hazard to patients, and enhance the appropriate diagnosis. Quality control tests were carried out at six fixed X-ray units at National Academy of Medical Sciences, Bir Hospital and National Trauma Center. Parameters like kVp accuracy, timer accuracy, Reproducibility of kV, time and dose, variable mA and radiation output Linearity with the acceptance limits were checked. Radiation leakage, spatial resolution, contrast resolution and field alignment tests were also carried out. Quality control tests of kVp dose, dose rate, HVL, mAs, beam alignment and leakage radiation shows mixed results. The measured values were within limit in four X-ray units. Until now we do not have any regulations in Nepal on acceptance testing of x-ray units after installation. The need for quality assurance of X-ray needs to be taken to avert detrimental effects to patients and staff. Institutes must introduce a mandatory system for acceptance tests of X-ray when installed and alongside regular quality control programs.

Implementing proactive quality assurance quality control (QAQC) and quality management (QM) practices at coal testing laboratories

Many commercial coal testing laboratories are accredited to ISO 17025 – General requirements for the competence of testing and calibration laboratories. There is an expected reliance in the Coal mining industry that the laboratory adheres to all elements of this standard in between successive accreditation audits conducted every 18 months by the independent accreditation body, National Association of Testing Authorities (NATA). In the absence of proactive QAQC &amp; QM practices monitoring the quality of the information reported by laboratories, potential issues impacting production decisions and reconciliation results are only determined in a reactive manner. In addition, for mining companies working with several internal and external laboratories across the supply chain, the management of the logistics, practices and information becomes very challenging and time-consuming, impacting the company’s ability to track laboratory results as key inputs in a production and reconciliation perspective. The absence of proactive QAQC &amp; QM practices results in a sub-optimal/reactive approach in the Coal industry, increasing the risk of short-term unaware production gaps related to quality, increased time required for quality breach investigations, the absence of a holistic approach/monitoring in the value chain, and the financial impact for the business performing under sub-optimal conditions. This paper aims to show the journey towards the implementation of a new proactive QAQC and QM program, where now the quality of many different laboratories across the supply chain can be monitored and linked with global reconciliation results, as an improvement opportunity to complement the current industry standard ISO 17025 accreditation and Proficiency Round Robin approach.

Identification of potential odorant markers to monitor the aroma formation in kilned specialty malts

Specialty malts are strategic ingredients regarding their contribution to colour and flavour of beer. Malts with the same colour may present distinct flavour characteristics and intensities. Contradictorily, colour is the benchmark in practical quality control. To investigate the correlation between colour and flavour of kilned barley specialty malts, odorants of commercial products of pale ale (5–9 EBC), Vienna (6–10 EBC), Munich (11–35 EBC) and melanoidin malts (80–90 EBC) were screened via solvent-assisted flavour evaporation (SAFE) and compared via comparative aroma extract dilution analysis (cAEDA). Subsequently, selected odorants were quantified using solid-phase microextraction (SPME). A total of 34 odorants were detected, of which 12 exhibited a concentration increase as the coloration increased, whereas 4 suggested the influence of temperature and modification degree on aroma formation. Such odorants are thus elected as potential markers for monitoring the influence of process variations on the formation of aroma in commercial kilned specialty malts.

A Resistivity Plate Loading Device for Assessing the Factors Affecting the Stiffness of a Cement-Stabilized Subgrade.

The extent of mixing in the stabilization process and the control of the cement content (C) and water content (w) in the mixture are key to the outcome of the engineering performance of a cement-stabilized subgrade. Intelligent Compaction (IC) quality control has improved quality control and management practices during construction. Intelligent Compaction Measurement Values (ICMVs) selected to evaluate the stiffness properties of cement-stabilized soils do not directly relate to the stiffness properties of the cement-stabilized subgrade and do not consider w and C. Additional tests need to be conducted for calibration of ICMVs. In this study, our solution is the development of a resistivity plate loading test. The resistivity plate loading test features the flexibility in determining the soil stiffness, w, C, and other important factors, such as the time of test effect (hydration) (T) and dry density (ρd). To verify the accuracy of the testing method, laboratory experimental studies were conducted on cemented soils considering ρd, w, C, and T at different factor levels. Multiple response studies based on grey rational analysis (GRA) were conducted. Analysis of the input factors was performed, and their effects on the measured responses were quantified. According to the study, the ρ measured by the device was a powerful indicator of stiffness, ρd, w, C, and T, which showed that the device can be useful equipment for quality control and an advancement in the in situ testing technologies and test equipment. A statistical regression model based on the linear and linear plus interaction terms among the factors is proposed to predict the average responses.

Reduction of Defect Rate in Biscuit Production using Statistical Quality Control Process

A business setting requires the practice of quality control to develop reliability, increase productivity and consumer consummation. The level of a lower control limit and an upper control limit in biscuit manufacturing and packing are considered. A total of 58000 biscuit packets are produced. Each week, 725 packets are inspected. Out of that number, 455 packets are defective. An inspection of certain randomly selected completed products will be conducted every week in this study.

Physiology assays in human kidney organoids.

Kidney organoids derived from human pluripotent stem cells constitute a novel model of disease, development, and regenerative therapy. Organoids are human, experimentally accessible, high throughput, and enable reconstitution of tissue-scale biology in a petri dish. Although gene expression patterns in organoid cells have been analyzed extensively, less is known about the functionality of these structures. Here, we review assays of physiological function in human kidney organoids, including best practices for quality control, and future applications. Tubular structures in organoids accumulate specific molecules through active transport, including dextran and organic anions, and swell with fluid in response to cAMP stimulation. When engrafted into animal models in vivo, organoids form vascularized glomerulus-like structures capable of size-selective filtration. Organoids exhibit metabolic, endocrine, injury, and infection phenotypes, although their specificity is not yet fully clear. To properly interpret organoid physiology assays, it is important to incorporate appropriate negative and positive controls, statistical methods, data presentation, molecular mechanisms, and clinical data sets. Improvements in organoid perfusion, patterning, and maturation are needed to enable branching morphogenesis, urine production, and renal replacement. Reconstituting renal physiology with kidney organoids is a new field with potential to provide fresh insights into classical phenomena.

Statistical process control tools for setup reproducibility in quality control practices during nasopharyngeal carcinoma radiotherapy

Statistical process control tools for setup reproducibility in quality control practices during nasopharyngeal carcinoma radiotherapy

Development and Evaluation of Interactive Flipped e-Learning (iFEEL) for Pharmacy Students during the COVID-19 Pandemic.

Background: Distance learning has come to the forefront of educational delivery throughout the world due to the COVID-19 pandemic. Presently, there is a paucity of studies that have utilized interactive e-lectures as a model for remote flipped learning. Objectives: To compare educational outcomes for the remote interactive flipped e-learning (iFEEL) activity versus paper-based in-class group learning (PICkLE). Methods: During the spring 2021 semester, tutorials in pharmaceutical quality control and good manufacturing practice were remotely delivered to students by two different approaches: PICkLE and iFEEL. In the latter activity, interactive e-lectures were software-designed and included several audiovisual enhanced illustrations to encourage students to interact with the lecture material prior to attending the virtual class. The class time was reserved for in-class quizzes and discussion. Mean exam scores were compared and voluntary questionnaires were distributed among the participating students as well as healthcare faculty members in 29 Saudi universities. Data from the remotely-delivered course was compared with data from previous course offerings (2018–2020) that used the live PICkLE method. Results: The mean score of post-lecture tests significantly (p < 0.05) increased compared to pre-lecture tests in remote PICkLE and iFEEL, respectively. iFEEL activity showed higher mean post-tests score (95.2%) compared to live PICkLE (90.2%, p = 0.08) and remote PICkLE (93.5%, p = 0.658). Mean comprehensive exam scores increased from 83.8% for remote PICkLE to 89.2% for iFEEL (p = 0.449). On average, 92% of students and 85% of faculty members reported positive feedback on the five quality attributes of the e-lecture. Over 75% of students preferred the iFEEL over PICkLE activity for future course offerings and 84% of faculty members recommend the integration of interactive e-lectures in their future courses. Conclusion: iFEEL represents a novel model of remote flipped learning and shows promising potential to be incorporated into live blended-learning classroom activities.

PH effect on colloidal characteristics of micro-nano particles in lapsang souchong black tea infusion

Tea infusion is a colloidal system. As a first attempt to systematically characterize tea micro-nanoparticles, the effect of pH on colloidal properties of Lapsang souchong black tea infusion was investigated in this study. At the native pH 5 of black tea infusion, micro/nanoparticles were revealed by Cryo-TEM (Cryo-transmission electron microscopy) to be of a structure consisting of dominantly spherical polyphenol oxidase (PPO)-polyphenols complexes and surrounding linear polysaccharide chains with an average hydrodynamic diameter ( D h ) of 128 nm and ζ-potential of −23.7 mV. It is the first time to demonstrate the black tea micelle consists of spherical and fibrous nanostructures, possibly responding to protein and polysaccharides. Increasing pH resulted in a decrease in polyphenols content and the disassembling of the micro/nanostructure. On the other hand, the decrease of pH through their respective isoelectric points led to the formation of PPO-polyphenols complexes, polysaccharide aggregation, and further aggregations among different molecules and their complexes and a drastic increase in the precipitation when pH was lower than pH 5. The predominant effect of pH on colloidal properties of black tea infusion reveals an electrostatic nature of intramolecular and intermolecular interactions among PPO, polysaccharides and polyphenols. Those results provide new clues to a practical and effective quality control of black tea products as well as an insight into health benefits of black tea. • The black tea contains negatively charged NPs (Dh = 128 nm) at its native pH of 5. • Increasing pH induced the disassembly of the micro/nanostructure. • pH < 5, formation of complexes and precipitates was promoted. • Electrostatic interaction primarily defines the nanostructure.

Monitoring cardiopulmonary resuscitation quality in emergency departments: a national survey in China on current knowledge, attitudes, and practices

BackgroundTo investigate current knowledge, attitudes, and practices for CPR quality control among emergency physicians in Chinese tertiary hospitals.MethodsAnonymous questionnaires were distributed to physicians in 75 tertiary hospitals in China between January and July 2018.ResultsA total of 1405 respondents answered the survey without obvious logical errors. Only 54.4% respondents knew all criteria of high-quality CPR. A total of 91.0% of respondents considered CPR quality monitoring should be used, 72.4% knew the objective method for monitoring, and 63.2% always/often monitored CPR quality during actual resuscitation. The main problems during CPR were related to chest compression: low quality due to fatigue (67.3%), inappropriate depth (57.3%) and rate (54.1%). The use of recommended monitoring methods was reported as follows, ETCO2 was 42.7%, audio-visual feedback devices was 10.1%, coronary perfusion pressure was 17.9%, and invasive arterial pressure was 31.1%. A total of 96.3% of respondents considered it necessary to participate in regular CPR retraining, but 21.4% did not receive any retraining. The ideal retraining interval was considered to be 3 to 6 months, but the actual interval was 6 to 12 months. Only 49.7% of respondents reported that feedback devices were always/often used in CPR training.ConclusionChinese emergency physicians were very concerned about CPR quality, but they did not fully understand the high-quality criteria and their impact on prognosis. CPR quality monitoring was not a routine procedure during actual resuscitation. The methods recommended in guidelines were rarely used in practice. Many physicians had not received retraining or received retraining at long intervals. Feedback devices were not commonly used in CPR training.

Value of BI-RADS 3 Audits.

BI-RADS 3 is an established assessment category in which the probability of malignancy is equal to or less than 2%. However, monitoring adherence to imaging criteria can be challenging and there are few established benchmarks for auditing BI-RADS 3 assignments. In this study, we explore some parameters that could serve as useful tools for quality control and clinical practice management. This retrospective study covered a 4-year period (Jan 2014-Dec 2017) and included all women over 40 years who were recalled from a screening exam and had an initial assignment of BI-RADS 3 (probably benign) category after diagnostic workup. A follow-up period of 2 years following the assignment of BI-RADS 3 was used for quantitative quality control metrics. Among 135,765 screening exams, 13,453 were recalled and 1,037 BI-RADS 3 cases met inclusion criteria. The follow-up rate at 24 months was 86.7%. The upgrade rate was 7.4% (77/1,037) [CI: 5.9-9.2%] and the PPV3 was 33.8% (26/77) [CI: 23.4-45.5%]. The cancer yield was 2.51% (26/1,037) [CI: 1.64-3.65%] and did not differ (p=0. 243) from the 2% probability of malignancy. The initial BI-RADS3 per screening exam and per recall from screening were 0.76% (1,037/135,765) [CI: 0.72-0.81%] and 7.7% (1,037/13,453) [CI: 7.26-8.17%], respectively. Regular audit of BIRADS 3 metrics has the potential to provide additional insights for clinical practice management. Data from varied clinical settings with input from an expert committee could help establish benchmarks for these metrics.

Meeting Measurement Precision Requirements for Effective Engineering of Genetic Regulatory Networks.

Reliable, predictable engineering of cellular behavior is one of the key goals of synthetic biology. As the field matures, biological engineers will become increasingly reliant on computer models that allow for the rapid exploration of design space prior to the more costly construction and characterization of candidate designs. The efficacy of such models, however, depends on the accuracy of their predictions, the precision of the measurements used to parametrize the models, and the tolerance of biological devices for imperfections in modeling and measurement. To better understand this relationship, we have derived an Engineering Error Inequality that provides a quantitative mathematical bound on the relationship between predictability of results, model accuracy, measurement precision, and device characteristics. We apply this relation to estimate measurement precision requirements for engineering genetic regulatory networks given current model and device characteristics, recommending a target standard deviation of 1.5-fold. We then compare these requirements with the results of an interlaboratory study to validate that these requirements can be met via flow cytometry with matched instrument channels and an independent calibrant. On the basis of these results, we recommend a set of best practices for quality control of flow cytometry data and discuss how these might be extended to other measurement modalities and applied to support further development of genetic regulatory network engineering.