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Study of Drug Production and Quality Control Process in Factories: A Case Study in Tolid Mavade Avallieh Daroupakhsh 工厂药品生产与质量控制过程研究——以达鲁帕什托利德为例
Pub Date : 2022-03-01 DOI: 10.24203/ajas.v10i1.6922
M. Torkashvand, A. Hasan-Zadeh
Tolid Mavade Avallieh Daroupakhsh Company is known as the largest producer of pharmaceutical active pharmaceutical ingredients in the Middle East and as one of the reputable companies in the field of production of narcotic and non-narcotic products worldwide.In addition to production, this complex has not neglected to consider environmental issues. In this regard, for many years, environmental protection has been seriously on its agenda, and since 2007, with the formation of an independent unit called "Production Support Unit" has followed this path more seriously. The first task of pharmaceutical manufacturers is to ensure the safety and effectiveness of their products. It is important only in the case of continuous quality control methods. For this reason the company has various departments including management, accounting, administrative and commercial affairs, planning manager, technical manager, laundry, warehouse manager, control laboratory, production control, synthesis, formulation, production management, production manager, packaging, coating, Facilities, technical management of warehouse, packaging and active pharmaceutical ingredients. Tests performed by a chemist on active pharmaceutical ingredients and drug quality are performed in a controlled laboratory. Other tasks include quality control and assurance and the development of control methods to ensure and match the production process with good GMP production operations. In the new pharmacy, another task is the responsibility of this department, and that is to ensure the compatibility of biological studies and clinical tests with good laboratory operations GLP and good clinical operations GCP. For example, these operations will be controlled by the quality control and assurance department, and their compliance with GCP, GMP, GLP is confirmed. All of these cases are discussed in detail in this paper.
Tolid Mavade Avallieh Daroupakhsh公司是中东地区最大的药用活性药物成分生产商,也是全球麻醉品和非麻醉品生产领域的知名公司之一。除了生产,这个综合体也没有忽视环境问题。在这方面,多年来,环保一直被严肃地提上日程,自2007年以来,随着独立单位“生产支持单位”的成立,环保工作更加认真地走上了这条道路。药品制造商的首要任务是确保其产品的安全性和有效性。只有在持续的质量控制方法的情况下,它才是重要的。为此公司设有管理、会计、行政商务、计划经理、技术经理、洗衣房、仓库经理、控制实验室、生产控制、合成、配方、生产管理、生产经理、包装、涂料、设施、仓库技术管理、包装和原料药等部门。化学家对活性药物成分和药品质量的测试在受控实验室进行。其他任务包括质量控制和保证以及控制方法的开发,以确保生产过程与良好的GMP生产操作相匹配。在新药房,该部门的另一项任务是确保生物研究和临床试验具有良好的实验室操作GLP和良好的临床操作GCP的兼容性。例如,这些操作将由质量控制和保证部门控制,并确认其符合GCP, GMP, GLP。本文对这些案例进行了详细的讨论。
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引用次数: 0
Attitude of Coastal Communities on Mangrove Forest Management: A Phenomenological Study from Bulukumba Regency, Indonesia 沿海社区对红树林管理的态度:来自印度尼西亚Bulukumba摄政的现象学研究
Pub Date : 2022-03-01 DOI: 10.24203/ajas.v10i1.6877
Rosmiati, Bachrani Rauf, Faiza Amir
Mangrove forests play a vital role in the survival of humans, animals, and plants in coastal areas. However, in reality, the mangrove area is getting more and more damaged due to human activities. This study aims to explore the attitudes of coastal communities in managing sustainable mangrove forests in both production and ecological functions. The design used in this study is a qualitative design with a phenomenological approach that does not aim to seek generalization but to explore in-depth information about the attitudes of coastal communities towards mangrove forest management. This study involved 31 participants consisting of government officials to coastal communities. Data was collected through research instruments in the form of interviews, observations, and documentation. After the data is collected, it is then analyzed using an interactive analysis model. The results show that coastal communities in Bulukumba district, Indonesia, have realized the importance of mangrove forests. They have participated in managing the mangrove forest based on the direction of the local government, which has implemented the mangrove forest replanting program.
红树林对沿海地区人类、动物和植物的生存起着至关重要的作用。然而,在现实生活中,由于人类活动的影响,红树林受到越来越多的破坏。本研究旨在探讨沿海社区在管理可持续红树林生产和生态功能方面的态度。本研究中使用的设计是一种采用现象学方法的定性设计,其目的不是寻求概括,而是探索有关沿海社区对红树林管理态度的深入信息。本研究涉及31名沿海社区的政府官员。数据是通过访谈、观察和文献的形式通过研究工具收集的。收集数据后,将使用交互式分析模型对其进行分析。结果表明,印度尼西亚Bulukumba地区的沿海社区已经意识到红树林的重要性。在当地政府的指导下,他们参与了红树林的管理,并实施了红树林重新种植计划。
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引用次数: 1
Development of Discovery Learning Based Science Learning Model Oriented Character Education 面向素质教育的基于发现学习的科学学习模式的发展
Pub Date : 2022-02-24 DOI: 10.24203/ajas.v10i1.6849
Cayati, H. Upu, Mustafa
Development of discovery learning based science learning model-oriented character education. This research aimed to determine the validity, practicality and effectiveness of science learning model development based on discovery learning oriented character education of class IV Elementary School in Pallangga Subdistrict of Gowa Regency. This study applied kinds of Research and Development (R & D) related to Borg and Gall model. Data collection used observation, questionnaire, documentation, interview, validity sheet, practicality and effectivity of product. Data were analyzed by using descriptive narrative and inferential statistics. The results of study indicated that: (1) validity and practicality of discovery learning development based science learning model oriented character of class IV Elementary School in Pallangga Subdistrict of Gowa Regency whit a very valid category or very feasible ot used  and very practical; and (2) the effectiveness of discovery learning based science learning model oriented students’ character education was effective to used at class IV Elementary School in Pallangga Subdistrict of Gowa Regency.
基于发现学习的科学学习模式导向的品格教育的发展。本研究旨在确定果瓦县帕朗加街道小学四班以发现学习为导向的品格教育科学学习模式开发的效度、实用性和有效性。本研究应用了与Borg和Gall模型相关的各种研究与开发(r&d)。数据收集采用观察、问卷调查、文件、访谈、效度表、产品的实用性和有效性。数据分析采用描述性统计和推理统计。研究结果表明:(1)Gowa县Pallangga街道四班小学基于发现学习发展的科学学习模式导向特征的有效性和实用性,是一个非常有效的类别或非常可行的使用和实用性;(2)以发现学习为基础的以科学学习模式为导向的学生品格教育在果瓦县帕朗加街道小学四班实施效果显著。
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引用次数: 0
The Development of Audio-Visual Learning Media in Islamic Cultural History Subject for Eight Grade Students of MT’s Al-Amanah, Jeneponto MT Al-Amanah八年级学生伊斯兰文化史科目视听学习媒体的发展
Pub Date : 2022-02-24 DOI: 10.24203/ajas.v10i1.6844
Ihdiana, Ismail Tolla, Jumadi
The problem in this research were: what is the level of learning implementation and learning achievement of History and Culture of the VIII grade students of MTs Al-Amanah in Jeneponto Regency? The purpose of this study is to describe: An overview of the implementation of learning and learning achievement levels History of Islamic culture in class VIII students of MTs Al-Amanah in Jeneponto Regency. This research was development research (R&D). Development research was research which was oriented towards the development or refinement of a science in overcame a problem directly through an action and self-reflection based on the results of the research, which aimed to improve or enhance educational services that must be carried out in the context of classroom learning. Based on the research results that have been described in the previous chapter, the research results were formulated as follows: Achievement of learning Islamic History and Culture using audio-visual media Students of class VIII MTs Al-Amanah in Jeneponto Regency has a significant increase. Of the 38 students at Madrasa Tsanawiyah Al-Amanah Jeneponto Regency, 20 people got the high category and 13 people got the high enough category after taking action using audio-visual media. Different things before being given the action of using audio-visual media in Islamization learning material activities in South Sulawesi.
本研究的问题是:Jeneponto reggency Al-Amanah中学八年级学生的历史文化学习实施水平和学习成果如何?本研究的目的是描述:Jeneponto reggency Al-Amanah中学八年级学生伊斯兰文化史学习和学习成就水平的实施概况。这项研究是开发研究(R&D)。发展研究是一种以发展或改进一门科学为目标的研究,它直接通过基于研究结果的行动和自我反思来克服问题,其目的是改善或加强必须在课堂学习的背景下进行的教育服务。基于前一章所述的研究结果,研究结果制定如下:利用视听媒体学习伊斯兰历史文化的成就Jeneponto Regency八班MTs Al-Amanah的学生人数显著增加。在Tsanawiyah Al-Amanah Jeneponto Regency伊斯兰学校的38名学生中,有20人在使用视听媒体采取行动后获得了高分,13人获得了足够高分。在南苏拉威西岛的伊斯兰化学习材料活动中使用视听媒体之前,情况有所不同。
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引用次数: 0
Higher Order Thinking Skills (HOTs) based Assessment for Learning: A Model for Computer Networks Learning in Vocational School 基于高阶思维技能的学习评价:一种职业学校计算机网络学习模式
Pub Date : 2022-02-24 DOI: 10.24203/ajas.v10i1.6876
M. Yassir, Husain Syam, Hasanah Nur
Vocational High School is a kind of school that has a strategic role in fulfilling labors. One of the competencies that graduates of Vocational High School must have is the Higher Order Thinking Skills (HOTS). Many graduates of Vocational High School are not absorbed by industry because they do not have HOTS. This study aims to develop a HOTS-based Assessment for Learning (AFL) model that can be applied to learning computer networks for vocational students. This research is a development research using the modified model of Hopkins and Clark - Analysis, Design, Development, Implementation, and Evaluation (HC-ADDIE), which is a collaboration and modification of research, development, and diffusion model of the Hopkins and Clark - Instructional System Design - Analysis, Design, Development, Implementation, and Evaluation (HC-ISD ADDIE), and Classroom Action Research (CAR). The development stage includes designing a prototype model, validating the model, testing legibility, training teachers / observers, and implementing limited and expanded trials. The results showed that the HOTS-based AFL model of computer network learning for vocational students was successfully developed through the HC-ADDIE modified model.
职业高中是一所在履行劳动义务中具有战略作用的学校。高职毕业生必须具备的能力之一是高阶思维能力。许多职业高中毕业生没有被工业所吸收,因为他们没有HOTS。本研究旨在建立一套可应用于高职学生计算机网络学习的基于hot的学习评估(AFL)模型。本研究是对Hopkins and Clark - teaching System Design - Analysis, Design, development, Implementation, and Evaluation (HC-ADDIE)模型进行的一项开发性研究,该模型是对Hopkins and Clark - teaching System Design - Analysis, Design, development, Implementation, and Evaluation (HC-ISD ADDIE)和Classroom Action research (CAR)的研究、开发和推广模型的协作和修改。开发阶段包括设计原型模型、验证模型、测试易读性、培训教师/观察员以及实施有限和扩大的试验。结果表明,通过HC-ADDIE修正模型,成功开发了基于hots的中职学生计算机网络学习AFL模型。
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引用次数: 1
The Effectiveness of Being Success Learning Model in Computer Systems Subjects at Vocational High Schools “Being Success”学习模式在高职计算机系统课程中的有效性研究
Pub Date : 2022-02-24 DOI: 10.24203/ajas.v10i1.6851
Rahmat Mahmud, Syahrul, R. T. Mangesa
This study aims at determining the effectiveness of the Being Success model in improving student learning outcomes in Computer Systems subjects at Vocational High Schools (SMK). This study uses a quasi-experimental comparative quantitative approach with a pre-test post-test control group design as the research design. This study was conducted at SMKN 05 Makassar and SMKS Telkom Makassar on January 22 to April 22, 2021. The population in this study was class X students on the even semester with the field of Information and Communication Technology expertise in Computer Systems subjects for the 2020/2021 academic year. Subject selection was carried out purposively with certain considerations. Basic Competencies (KD) suitability and the consistency of subjects to participate in online learning activities during the pandemic are considered. Therefore, the subjects in this study involved two classes with 54 students consisting of 27 students of class X SMKN 05 Makassar as the experimental class and 27 students of class X SMKS Telkom Makassar as the control class. Data were obtained from the results of the pre-test and post-test in the form of multiple-choice questions. Furthermore, the data were analyzed using parametric t-test statistics with a significance level of 0.05. Based on the output of the Independent sample sig (2-tailed), the t-test was 0.000 <0.05. These results indicate that there is a significant difference in the acquisition of learning outcomes between the control class and the experimental class. It can be concluded that H0 is rejected and H1 is accepted. Based on the results of the calculation of the N-Gain Score from the pre-test and post-test values, the normalized gain value for the experimental class was 0.73, and the control class was 0.58. The values ​​obtained are then interpreted into the normalized gain value criteria (N-Gain); from these values, ​​it can be concluded that the effectiveness of the application of the Being Success model in the experimental class is in the high category.
本研究旨在确定成功模式在提高职业高中计算机系统科目学生学习成果方面的有效性。本研究采用准实验比较定量方法,采用前测后测对照组设计作为研究设计。该研究于2021年1月22日至4月22日在SMKN 05 Makassar和SMKS Telkom Makassar进行。本研究的研究对象是2020/2021学年计算机系统学科信息与通信技术专业中偶数学期的X班学生。选题是有目的的,有一定的考虑。考虑了大流行期间受试者参与在线学习活动的基本能力(KD)适用性和一致性。因此,本研究的被试分为两个班,共54名学生,其中X SMKN 05班27名学生为实验班,X SMKS Telkom望加锡班27名学生为对照班。数据以多项选择题的形式从前测和后测结果中获取。采用参数t检验统计量进行分析,显著性水平为0.05。根据独立样本sig(双尾)的输出,t检验为0.000 <0.05。这些结果表明,控制班和实验班在学习成果的习得上存在显著差异。可以得出H0被拒绝,H1被接受的结论。根据前测和后测值计算N-Gain Score的结果,实验组归一化增益值为0.73,对照组归一化增益值为0.58。然后将获得的值解释为归一化增益值标准(N-Gain);从这些值可以看出,成功模式在实验班的应用有效性处于较高的类别。
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引用次数: 0
Subsurface Evapotranspiration Irrigation System Design in System of Rice Intensification (SRI) Salibu Paddy Cultivation Salibu水稻集约化栽培系统地下蒸散灌溉系统设计
Pub Date : 2022-02-24 DOI: 10.24203/ajas.v10i1.6891
Hilda Agustina, B. Setiawan, Sugiyanta, M. Solahudin, V. A. Dewi
The System of Rice Intensification (SRI), a water-saving paddy cultivation system, has been implemented in Indonesia. The application of SRI  can increase water productivity. The Salibu method applied to paddy cultivation can save seeds, costs, labour and increase the planting index of paddy. However, when used in other areas, the yield is reduced by up to 50 per cent from the first harvest. A combination of cultivation and water management is needed to save water and increase paddy production. The method used in this research is experimental research. The design of the irrigation system was made according to the technical design, then tested for automatic water management. The design was tested with the SRI Salibu method. The data are climate data, water level, water discharge, and water content. The climate data used are temperature and solar radiation to determine potential evapotranspiration. The results of observations of water depth, the volume of water in the system, the water content in the media, water entering the system (rain infiltration, irrigation discharge), and water leaving the system (runoff, discharge) are entered into the water balance equation (water balance). The plant coefficient value is included in the water balance equation as a plant coefficient factor multiplied by the potential evapotranspiration value. Then the plant coefficient value for each observation is optimized by reducing the error value to get the coefficient value for SRI Salibu. The results showed that the appropriate evapotranspiration irrigation system for SRI Salibu paddy cultivation is the fifth irrigation system design. The fifth irrigation system design can produce 4.7 tons/ha of paddy (SRI method) and produce SRI Salibu paddy yields of 8 tons/ha. The irrigation water for SRI paddy cultivation is 1738 litres, and the water production is 1.2 kg/m3.
水稻集约化系统(SRI)是一种节水水稻种植系统,已在印度尼西亚实施。SRI的应用可以提高水生产力。将Salibu法应用于水稻栽培,可节省种子、成本、劳动力,提高水稻种植指数。然而,当在其他地区使用时,产量比第一次收获时减少了50%。要节约用水,提高水稻产量,必须实行种田和治水相结合。本研究采用的方法是实验研究。根据技术设计对灌溉系统进行了设计,并进行了自动化水管理试验。采用SRI Salibu法对设计进行了检验。数据包括气候数据、水位数据、水量数据和含水量数据。使用的气候数据是温度和太阳辐射来确定潜在的蒸散量。将水深、系统水量、介质含水量、进入系统的水量(雨水入渗、灌溉排放)和离开系统的水量(径流、排放)的观测结果,输入到水量平衡方程(水平衡)中。植物系数值以植物系数因子乘以潜在蒸散值的形式包含在水分平衡方程中。然后通过减小误差值对每一次观测的植物系数值进行优化,得到SRI Salibu的系数值。结果表明,适合SRI Salibu水稻蒸散灌溉的灌溉系统是第五种灌溉系统设计。第五种灌溉系统设计可生产4.7吨/公顷水稻(SRI法),SRI Salibu水稻产量为8吨/公顷。SRI水稻灌溉水量1738升,产水量1.2 kg/m3。
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引用次数: 1
The Development of Modeling Physics Learning to Improve Critical Thinking Ability of Student 发展物理建模学习提高学生批判性思维能力
Pub Date : 2022-02-24 DOI: 10.24203/ajas.v10i1.6842
M. Arifuddin, S. Thalib, J. Jasruddin, Muhammad Sidin Ali
The low critical thinking skills of students in fundamental physics courses require an innovative learning model which is the main background in this research. This study aims to (1) know the description of the development of modeling physics learning (2) determine the validity of modeling physics learning to students' critical thinking skills. This type of research is Research and Development with a development model referring to the Wademan and Mckenney model. This research procedure includes preliminary studies, hypothetical model development, model operationalization, and model implementation. Collecting research data using validity assessment techniques and tests of physics competence and critical thinking skills. The data obtained were analyzed by descriptive quantitative. This research shows that (1) Modeling Physics Learning has five phases, namely submission and identification of problems with physical phenomena, provision of prerequisite information, physics modeling, finding solutions, evaluating processes and solutions, (2) The PPF learning model developed in this study is declared feasible because it fulfills the criteria of validity and effectiveness.
基础物理课程学生的批判性思维能力低下,需要创新的学习模式,这是本研究的主要背景。本研究旨在(1)了解物理建模学习发展的描述(2)确定物理建模学习对学生批判性思维能力的有效性。这种类型的研究是研究与开发,其开发模型参考了Wademan和Mckenney模型。本研究过程包括初步研究、假设模型开发、模型操作和模型实施。使用有效性评估技术和物理能力和批判性思维技能测试收集研究数据。对所得数据进行描述性定量分析。研究表明:(1)建模物理学习有5个阶段,即物理现象问题的提交和识别、前提信息的提供、物理建模、寻找解决方案、评估过程和解决方案;(2)本研究建立的PPF学习模型满足有效性和有效性标准,被认为是可行的。
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引用次数: 0
The Effect of Open-Ended Approach on Automotive Electricity Learning in SMK Negeri 3 Makassar 开放式教学方法对中国汽车电力学习的影响
Pub Date : 2022-02-24 DOI: 10.24203/ajas.v10i1.6853
Muhammad Komeini, M. Yahya, P. Purnamawati
This study aims (1) to find out the students' capabilities in the closed-ended teaching method; (2) to find out the students' capabilities in the open-ended teaching method with a scenario; (3) to find out whether there is an effect of the open-ended teaching method with a scenario on the students' capabilities to solve automotive electrical system problems with problem-based scenarios. The research subject involved a whole class (consisting of 25 students) selected by the purposive sampling technique. The data were collected through observation, tests, interviews, and documentation, then analyzed with descriptive statistical analysis of percentages, frequency distribution tables and hypothesis testing with nonparametric statistical analysis, Mann Whitney test with SPSS-PC 20.0 for windows. The results of the data analysis showed that: (1) the students' capabilities to assemble an automotive electrical system (closed-ended teaching method) was 88%, (2) the students' capabilities to solve automotive electrical problems with a problem-based scenario (open-ended teaching method in a scenario) was 72 %, (3) the effect of the students' capabilities in assembling electricity (closed-ended teaching method) was higher than the students' capabilities to solve electrical problems (scenario of open-ended teaching).
本研究的目的是:(1)了解封闭式教学中学生的能力;(2)通过情景化开放式教学,发现学生的能力;(3)考察开放式情景教学法对学生运用基于问题的情景解决汽车电气系统问题的能力是否有影响。本研究采用目的抽样的方法,选取了一个班级的25名学生作为研究对象。采用观察法、检验法、访谈法和文献法收集资料,采用百分比描述性统计分析、频率分布表分析和假设检验,采用spss - pc20.0 for windows进行非参数统计分析和Mann Whitney检验。数据分析结果表明:(1)学生组装汽车电气系统的能力(封闭式教学法)为88%,(2)学生解决基于问题的情景(开放式教学法中的情景)的汽车电气问题的能力为72%,(3)学生组装电气的能力(封闭式教学法)的效果高于学生解决电气问题的能力(开放式教学情景)。
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引用次数: 0
Design of Contextual Teaching and Learning (CTL) Model to Improve Student's Life Skills: The Development Phase in Research and Development 情境教学模式的设计以提高学生的生活技能:研究与开发的发展阶段
Pub Date : 2022-02-24 DOI: 10.24203/ajas.v10i1.6848
Nurmadiah, Ismail Tolla, Baso Jabu
One of the teacher's abilities in supporting learning objectives is to design learning products according to the needs in the field. To determine the quality of the developed product, the teacher must conduct several tests involving experts, students, and teachers. This study aims to assess the quality of the learning model that has been developed by researchers, namely the Contextual Teaching & Learning (CTL) learning model to improve students’ life skills through Islamic Religious Education (IRE) subjects. This research is a development phase in research & development methods focusing on testing the validity, practicality, and effectiveness of the learning model. There were three groups of participants included in this study, namely experts, teachers, and students, who were selected using a purposive sampling technique. Data were collected using several instruments, namely: (1) validation sheets, (2) teacher response questionnaires, and (3) life skills observation sheets. The collected data is then analyzed quantitatively to determine the categories of validity, practicality, and effectiveness. The study results show that the CTL learning model is proven to be valid, practical, and effective in improving the life skills of high school students.
教师支持学习目标的能力之一是根据该领域的需要设计学习产品。为了确定所开发产品的质量,教师必须进行几次涉及专家、学生和教师的测试。本研究旨在评估研究人员开发的学习模式的质量,即情境教学与学习(CTL)学习模式,通过伊斯兰宗教教育(IRE)科目提高学生的生活技能。本研究是研究开发方法的一个发展阶段,重点是测试学习模式的有效性、实用性和有效性。本研究共有三组参与者,即专家、教师和学生,他们采用有目的的抽样技术进行选择。数据收集使用几种工具,即:(1)验证表,(2)教师回答问卷和(3)生活技能观察表。然后对收集到的数据进行定量分析,以确定有效性、实用性和有效性的类别。研究结果表明,CTL学习模式在提高高中生生活技能方面是有效的、实用的和有效的。
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引用次数: 0
期刊
Asian Journal of Applied Sciences
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