Technology Transfer as the Process of Pharmaceutical Quality System： Modelling Technology Transfer as a Process Strategy

The recent GMP （good medical practice） rules actualisation and its requirements introduction widened the GMP guidelines for every life cycle of medicinal products, including the stage of processes scaling and technology transfer. This requires the technology transfer process to be regulated as the part of pharmaceutical quality system and the following development of corresponding written procedures. The following publication is dedicated to the development of TTP （technology transfer process） and its accessible graphic formalisation alongside the definition of main stages and possible procedures limited by the offered model. According to the actualized GMP rules, the technology transfer is an essential part of pharmaceutical quality system at a modem pharmaceutical company.

On the Fabrication of Structural Model of Quality System of Urbanization in China

This paper classifies the factors related with the quality system of the urbanization into three dimensions as quality planning, quality realization and quality improvement according to the relationship of their mutual actions. Then it fabricates a three-dimension space structural model. In order to achieve sustainable improvement on urbanization quality improvement, this paper puts forward the measures of controlling the operation of the quality system of urbanization to make it run effectively and smoothly.

Continuing to Perfect the Quality System

Afirst-class forwarding agent company approved by the Ministry of Foreign Trade and Economic Cooperation,the Ministry of Communication, the General Customs and the Civil Aviation Administration of China, the Shanghai Jinhai Jieya International Forwarding Co. Ltd comprises the Shanghai Haigang Industrial General Company,Shanghai Jin Jiang Associated Corporation (Group) and Hongkong Jieya Air Freight Forwarding Corporation, in the form of a joint venture.

Improve the Center Supply Room to Ensure the Quality System for Disinfection and Sterilization

The disinfection supply room is a very important department of the hospital.Its main job is to provide sterile equipment and dressings for various activities in the hospital.It is an important department in the hospital infection management process.Doing a good job in the control and management of the disinfection supply room is the main link to ensure the prevention and control of hospital infections.The quality of management directly affects modern clinical medical work.Therefore,the hospital supply room should be strengthened and improved to ensure that all items can be safely used in the work process,which can effectively avoid the occurrence of cross-infection incidents in the hospital.

Implementing a paperless and integrated pharma quality system

Compliance to the PIC/s GMP[1]standards is a mandatory and challenging requirement for ASEAN Pharmaceutical manufactures.PIC/s has at its foundation and as a very strong basis the need for a robust and wide ranging Quality Management System that will impact nearly all the departments in the organization and requires companies to setup detailed controls and records across all relevant quality aspects.To achieve the PIC/s quality objectives reliably and efficiently,a comprehensively designed and implemented QMS will be based on the Quality Assurance principles and will integrate GMP,Quality Control and Quality Risk Management.The key functions required in a QMS are Document Control,Training Management Quality Event Management Quality Risk Management(QRM),Supplier Management and Audit Management.By operating a paper QMS.

A New Development of BQS （Blastability Quality System） for Closely Spaced Formations

Success in the excavation of geological formations is commonly known as being very important in asserting stability. Furthermore, when the subjected geological formation is rocky and the use of explosives is required, the demands of successful blasting are multiplied. The present paper proposes a classification system, named： BQS （Blastability Quality System）, for rock masses with closely spaced discontinuities （spacing lower than 0.1 m）. It is obvious that rock quality is one of the main characteristics which define the blast ability of a rock. The BQS can be an easy and widely-used tool as it is a quick evaluator for blastability and rock mass quality at one time. Taking into consideration the research calculations and the parameters of BQS, what has been at question in this paper is the effect of blast ability in a geological formation with closely spaced discontinuities.

The Self-inspections(Internal Audits)Process as a Part of the Pharmaceutical Quality System:Formation of a Risk-Based Approach to Internal Audits Planning

The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to its withdrawal from production.The principal difference between PQS and GxP rules from other quality systems is that the medicinal product,its safety and efficacy is put at the forefront.At the same time,PQS implies a process approach to all components that should be aimed at achieving the main goal—ensuring and guaranteeing the quality of the medicinal product for the end user(patient)—and should be based on the quality risk management system.An integral part of PQS,as well as the GxP rules adopted in the European Union and PIC/S,is a process for self-inspections and/or quality audits,which regularly appraises the effectiveness and applicability of the PQS.This publication is dedicated to the definition of self-inspections(internal audits)as one of the PQS’s processes.The article defines the main standard stages and develops a model of a risk-based approach to the self-inspections’planning in relation to processes of the pharmaceutical quality system.

Exploring the relationship between ambient sulfur dioxide and semen quality parameters:A systematic review and meta-analysis

Objective:To investigate the relationship between ambient sulfur dioxide(SO2)exposure and semen quality parameters.Methods:A systematic literature search was conducted to identify relevant studies investigating the association between SO2 exposure and semen quality parameters.This search encompassed the timeframe from January 2000 to May 2023 and included electronic databases such as Web of Science,Google Scholar,PubMed,Cochrane,and Scopus.Pooled effect estimates with 95%confidence intervals(CI)were calculated using percent changes(PC).The meta-analysis included seven studies with 6711 participants and 15087 semen samples.Results:The results revealed a significant negative association between ambient SO2 exposure and certain semen quality parameters.In particular,SO2 exposure was associated with a significant decrease in progressive motility(PC=0.032;95%CI:-0.063 to-0.001;P=0.044)and sperm concentration(PC=-0.020;95%CI:-0.036 to-0.005;P=0.012).However,no statistically significant associations were observed for total sperm count(PC=-0.038;95%CI:-0.079 to 0.003;P=0.070),seminal fluid volume(PC=-0.009;95%CI:-0.048 to-0.030;P=0.662)and sperm motility(PC=-0.17;95%CI:-0.363 to 0.022;P=0.830).In addition,the results of the subgroup analysis revealed specific variables that were associated with the decrease in relevant sperm parameters.Conclusions:This systematic review and meta-analysis provides compelling evidence supporting a consistent negative association between exposure to ambient SO2 and semen quality parameters.

Remote sensing of quality traits in cereal and arable production systems:A review

Cereal is an essential source of calories and protein for the global population.Accurately predicting cereal quality before harvest is highly desirable in order to optimise management for farmers,grading harvest and categorised storage for enterprises,future trading prices,and policy planning.The use of remote sensing data with extensive spatial coverage demonstrates some potential in predicting crop quality traits.Many studies have also proposed models and methods for predicting such traits based on multiplatform remote sensing data.In this paper,the key quality traits that are of interest to producers and consumers are introduced.The literature related to grain quality prediction was analyzed in detail,and a review was conducted on remote sensing platforms,commonly used methods,potential gaps,and future trends in crop quality prediction.This review recommends new research directions that go beyond the traditional methods and discusses grain quality retrieval and the associated challenges from the perspective of remote sensing data.

Deep learning models semi-automatic training system for quality control of transthoracic echocardiography

Objective To explore the value of deep learning(DL)models semi-automatic training system for automatic optimization of clinical image quality control of transthoracic echocardiography(TTE).Methods Totally 1250 TTE videos from 402 patients were retrospectively collected,including 490 apical four chamber(A4C),310 parasternal long axis view of left ventricle(PLAX)and 450 parasternal short axis view of great vessel(PSAX GV).The videos were divided into development set(245 A4C,155 PLAX,225 PSAX GV),semi-automated training set(98 A4C,62 PLAX,90 PSAX GV)and test set(147 A4C,93 PLAX,135 PSAX GV)at the ratio of 5∶2∶3.Based on development set and semi-automatic training set,DL model of quality control was semi-automatically iteratively optimized,and a semi-automatic training system was constructed,then the efficacy of DL models for recognizing TTE views and assessing imaging quality of TTE were verified in test set.Results After optimization,the overall accuracy,precision,recall,and F1 score of DL models for recognizing TTE views in test set improved from 97.33%,97.26%,97.26%and 97.26%to 99.73%,99.65%,99.77%and 99.71%,respectively,while the overall accuracy for assessing A4C,PLAX and PSAX GV TTE as standard views in test set improved from 89.12%,83.87%and 90.37%to 93.20%,90.32%and 93.33%,respectively.Conclusion The developed DL models semi-automatic training system could improve the efficiency of clinical imaging quality control of TTE and increase iteration speed.

The Correlation between the Power Quality Indicators and Entropy Production Characteristics of Wind Power+Energy Storage Systems

Power quality improvements help guide and solve the problems of inefficient energy production and unstable power output in wind power systems.The purpose of this paper is mainly to explore the influence of different energy storage batteries on various power quality indicators by adding different energy storage devices to the simulated wind power system,and to explore the correlation between systementropy generation and various indicators,so as to provide a theoretical basis for directly improving power quality by reducing loss.A steady-state experiment was performed by replacing the wind wheel with an electric motor,and the output power qualities of the wind power systemwith andwithout energy storagewere compared and analyzed.Moreover,the improvement effect of different energy storage devices on various indicatorswas obtained.Then,based on the entropy theory,the loss of the internal components of the wind power system generator is simulated and explored by Ansys software.Through the analysis of power quality evaluation indicators,such as current harmonic distortion rate,frequency deviation rate,and voltage fluctuation,the correlation between entropy production and each evaluation indicator was explored to investigate effective methods to improve power quality by reducing entropy production.The results showed that the current harmonic distortion rate,voltage fluctuation,voltage deviation,and system entropy production are positively correlated in the tests and that the power factor is negatively correlated with system entropy production.In the frequency range,the frequency deviationwas not significantly correlated with the systementropy production.

Quality-adjusted life years and surgical waiting list:Systematic review of the literature

BACKGROUND The quality-adjusted life year(QALY)is a metric that is increasingly used today in the field of health economics to evaluate the value of different medical treatments and procedures.Surgical waiting lists(SWLs)represent a pressing problem in public healthcare.The QALY measure has rarely been used in the context of surgery.It would be interesting to know how many QALYs are lost by patients on SWLs.AIM To investigate the relationship between QALYs and SWLs in a systematic review of the scientific literature.METHODS The study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement.An unlimited search was carried out in PubMed,updated on January 19,2024.Data on the following variables were investigated and analyzed:Specialty,country of study,procedure under study,scale used to measure QALYs,the use of a theoretical or real-life model,objectives of the study and items measured,the economic value assigned to the QALY in the country in question,and the results and conclusions published.RESULTS Forty-eight articles were selected for the study.No data were found regarding QALYs lost on SWLs.The specialties in which QALYs were studied the most in relation to the waiting list were urology and general surgery,with 15 articles each.The country in which the most studies of QALYs were carried out was the United States(n=21),followed by the United Kingdom(n=9)and Canada(n=7).The most studied procedure was organ transplantation(n=39),including 15 kidney,14 liver,5 heart,4 lung,and 1 intestinal.Arthroplasty(n=4),cataract surgery(n=2),bariatric surgery(n=1),mosaicplasty(n=1),and septoplasty(n=1)completed the surgical interventions included.Thirty-nine of the models used were theoretical(the most frequently applied being the Markov model,n=34),and nine were real-life.The survey used to measure quality of life in 11 articles was the European Quality of Life-5 dimensions,but in 32 articles the survey was not specified.The willingness-to-pay per QALY gained ranged from$100000 in the United States to€20000 in Spain.CONCLUSION The relationship between QALYs and SWLs has only rarely been studied in the literature.The rate of QALYs lost on SWLs has not been determined.Future research is warranted to address this issue.

A Quality Evaluation System for Dissertation Based on Fuzzy Analytic Hierarchy Process

A dissertation is a research report or scientific paper written by an author to obtain a certain degree. It reflects postgraduates’ research achievements and the educational quality of an institute, even a country. To construct an optimized quality evaluation system for postgraduate dissertation (QESPD), we summarized the influencing factors and invited 10 experienced specialists to rate and prioritize them based on fuzzy analytic hierarchy process. Four primary indicators (innovation, integrity, scientificity and normativity) and 16 sub-indicators were selected to form the evaluation system. The order of primary indicators by weight, was innovation (0.4269), scientificity (0.2807), integrity (0.1728) and normativity (0.1196). The top five sub-dimensions were theoretical originality, scientific value, data reliability, design rationality and evidence credibility. To demonstrate the effectiveness of the proposed system, a case study was performed. In the case study, it was demonstrated that the established two-index-hierarchy QESPD in this study was a more scientific and reasonable evaluation system worthy of promotion and application.

Comparison of German and American Higher Education Accreditation Systems and Implications for Quality Management of Higher Education in China

At the present stage,China’s higher education has experienced continuous reform and enhancement,the scale of education has jumped to the forefront,and the quality of education has been continuously improved,which has made gratifying achievements.The development of China’s higher education has entered the critical node of improving quality and efficiency,and the importance of quality management as the central link in improving the quality of higher education is self-evident.Accreditation as an effective means of quality assurance,in Germany and the United States has formed a mature and perfect system and procedures.Therefore,analysing and learning from the quality management system of higher education in Germany and the United States has an important reference value for promoting the further development of quality management of higher education in China.

China’s Energy System Development Prospect and New Quality Productive Forces

Entering the post epidemic recovery stage,China’s economic development features acceleration of industrial structure optimization and upgrading.While energy demand is increasing rigidly,energy utilization efficiency is steadily improving,with cleaner energy consumption proportion rising.The direct relationship between China’s economic growth and its emissions may be loosening.New quality productive forces as characterized by innovation,greener and smarter manufacturing,industrial integration and promotion of high-quality economic development,are highly consistent with China’s energy transformation to drive an all-round green and low-carbon development in economy and society.They are bound to play an increasing important role in achieving energy security and build China’s strength in energy.

Mitophagy in acute central nervous system injuries:regulatory mechanisms and therapeutic potentials

Acute central nervous system injuries,including ischemic stro ke,intracerebral hemorrhage,subarachnoid hemorrhage,traumatic brain injury,and spinal co rd injury,are a major global health challenge.Identifying optimal therapies and improving the long-term neurological functions of patients with acute central nervous system injuries are urgent priorities.Mitochondria are susceptible to damage after acute central nervous system injury,and this leads to the release of toxic levels of reactive oxygen species,which induce cell death.Mitophagy,a selective form of autophagy,is crucial in eliminating redundant or damaged mitochondria during these events.Recent evidence has highlighted the significant role of mitophagy in acute central nervous system injuries.In this review,we provide a comprehensive overview of the process,classification,and related mechanisms of mitophagy.We also highlight the recent developments in research into the role of mitophagy in various acute central nervous system injuries and drug therapies that regulate mitophagy.In the final section of this review,we emphasize the potential for treating these disorders by focusing on mitophagy and suggest future research paths in this area.

Construction and Practice of Education and Teaching Quality Assurance Systems in Applied Colleges and Universities under the Background of Digital Intelligence

This paper discusses the optimization strategy of education and teaching quality assurance systems in applied colleges and universities under the background of digital intelligence.It first summarizes the relevant theories of digital intelligence transformation and analyzes the impact of digital intelligence transformation on higher education.Secondly,this paper puts forward the principles of constructing the quality assurance system of applied colleges,including strengthening the quality assurance consciousness,improving teachers’digital literacy,and implementing digital intelligence governance.From the practical perspective,this paper expounds on strategies such as optimizing educational teaching resource allocation,constructing a diversified evaluation system of teaching quality,strengthening the construction and training of teaching staff,and innovating teaching management methods.Specific optimization measures are put forward,such as improving policies,regulations,and system guarantees,strengthening cooperation between schools and enterprises,integrating industry,school,and research,building an educational information platform,and improving the monitoring and feedback mechanism of educational quality.

Investigation on quality of life of hospitalized patients in China with digestive system malignancy

Background: The purpose of this study is to evaluate the quality of life(QoL) of hospitalized patients in China suffering from digestive system malignancies and to identify potential risk factors for a decrease in QoL.Methods: The European Organization for Research and Treatment Core Quality of Life questionnaire(EORTC QLQ-C30) was applied to evaluate the QoL of 23,519 patients with six digestive malignancies(esophageal cancer, gastric cancer, colorectal cancer, liver cancer, biliary tract cancer, and pancreatic cancer). A t test or analysis of variance was employed to analyze the total EORTC QLQ-C30 scale scores and domain scores of the EORTC QLQ-C30 scale among patients in different subgroups.Results: The average QoL score was 50.4 ± 10.8. The tumor type, age, sex, and TNM stage al had an impact on QoL ratings. Colorectal cancer patients had a better total QoL score(49.3 ± 10.3) and scores in the domains of functioning, with milder symptoms, except for diarrhea. Patients with biliary tract cancer(54.2 ± 12.3) and pancreatic cancer(54.2 ± 12.3) reported a poorer QoL, significant functional impairment, and more pronounced symptoms. Patients with esophageal cancer experienced the most severe financial difficulties(35.2 ± 27.5). Patients aged ≥65 years, women, and those with TNM stage Ⅲ/Ⅳ reported lower QoL. In addition, the disparities in total QoL scores and scores in specific domains were significant among patients with some types of tumors, and based on ethnicity, educational level, occupation, treatment(s) received, and place of residence.Conclusions: There is a need to focus on elderly individuals, those with low educational levels, and patients with progressive malignant tumors and to improve routine disease monitoring and symptom management to enhance the quality of life for patients with malignancies of the digestive system.

Construction and Application of a Quality Evaluation System for Group Elderly Care Services Based on the Internet of Things

With the continuous intensification of global aging,the issue of elderly care has become an increasingly prominent social problem.The Internet of Things(IoT)technology,as an emerging field,holds broad application prospects.This article focuses on the application of IoT technology in group elderly care services and constructs a quality evaluation system for these services based on IoT technology.Through the analysis of practical application cases,the advantages and challenges of IoT technology in group elderly care services have been examined,confirming the feasibility and effectiveness of the evaluation system.