scholarly journals Quality in Non-Licensed Radiopharmaceutical Products: Are We Achieving the Goal?

2021 ◽  
Author(s):  
Estrella Moya Sánchez
Keyword(s):  
European Association ◽  
Marketing Authorisation ◽  
Small Scale ◽  
Efficacy And Safety ◽  
Quality Assurance Process ◽  
Guidance Documents ◽  
Scale Preparation ◽  
Assurance Process ◽  
Insight Into

Radiopharmaceutical compounds, considered a special group of medicines, can be prepared outside the marketing authorisation track. Small-scale preparations at non-commercial sites thereby represent an important segment, however a lack of harmonisation in the regulation leads to extreme differences in the application and availability of radiopharmaceuticals across Europe. A number of guidelines and guidance documents have been issued by European Association of Nuclear Medicine (EAMN), Pharmaceutical inspection convention (PICs), European Directorate for the Quality of Medicines & HealthCare (EDQM) to achieve a good radiopharmacy practice for small-scale preparation. Nevertheless, in the case of non-licensed radiopharmaceuticals their consideration as magistral formulas, in some countries, makes it possible to waive regulatory inspections aimed to ensure those good practices enforcement. Moreover, special attention should be put on the quality assurance process for non-licensed starting materials, given that the final radiopharmaceuticals quality chiefly depends on it. This paper (chapter) will provide an insight into the quality standards applicable to starting materials, such as supplier qualification control, starting material re-test period, etc. in order to raise for discussion about how best to achieve a proven quality, efficacy, and safety for our radiopharmaceuticals (licensed or non-licensed).

scholarly journals Manajemen Mutu Input Kelompok Bimbingan Ibadah Haji Indonesia

2017 ◽  
Vol 11 (2) ◽  
pp. 277-292
Author(s):  
Aep Kusnawan ◽  
Arif Rahman ◽  
Dede Lukman ◽  
Encep Dulwahab
Keyword(s):  
Quality Assurance ◽  
Quality Management ◽  
Qualitative Approach ◽  
One Dimension ◽  
Management Standard ◽  
Quality Assurance Process ◽  
Starting Point ◽  
Assurance Process

Hajj guidance group (KBIH) in Indonesia, still limited to quantity and have been not yet met the quality. One indication of the lack of quality of the KBIH is the quality management of inputs, namely the applied inputs and inputs of expectation. With good input and good, it can produce an out put that as expected. This study aims to determine the quality management of pilgrimage inputs by KBIH in Indonesia, represented by three regions, West Java, DKI Jakarta and South Sumatra. The method used in this research is case study with qualitative approach. This study shows that quality management for one dimension of input, especially in KBIH has not met the quality management standard. Implementation and embodiment is still limited to ideas, wishful thinking, and not conceptualized well. The results of this study have an impact on how the quality management of KBIH input in Indonesia should be implemented, so that with good input in KBIH, KBIH can improve the quality of Hajj in Indonesia. Input is a starting point in a quality assurance process, not to be ignored, underestimated, and considered not one of the important parts of quality management of its existence.Kelompok Bimbingan Ibadah Haji (KBIH) yang banyak berdiri di Indonesia, masih sebatas kuantitas belum memenuhi kualitas. Salah satu indikasi melihat kurangnya kualitas KBIH ialah pada manajemen mutu input, yaitu input terapan maupun input harapan. Dengan input yang baik dan bagus, maka bisa menghasilkan out put yang sesuai harapan. Penelitian ini bertujuan untuk mengetahui manajemen mutu input penyelenggaraan haji oleh KBIH di Indonesia, yang diwakili tiga wilayah, Jawa Barat, DKI Jakarta dan Sumatera Selatan. Metode yang digunakan dalam penelitian ini adalah studi kasus dengan pendekatan kualitatif. Penelitian ini memperlihatkan bahwa manajemen mutu untuk satu dimensi input, khususnya di KBIH belum memenuhi standar manajemen mutu. Pelaksanaan dan perwujudannya masih sebatas ide, angan-angan, dan belum terkonsep dengan baik. Hasil penelitian ini berdampak pada bagaimana manajemen mutu input KBIH di Indonesia seharusnya diimplementasikan, sehingga dengan input yang baik dalam KBIH, KBIH bisa meningkatkan kualitas penyelenggaraan ibadah haji di Indonesia. Input merupakan starting point dalam sebuah proses jaminan mutu, jangan sampai diabaikan, disepelekan, dan dianggap bukan salah satu bagian manajemen mutu yang penting keberadaannya.

scholarly journals Mechanism of the quality cost administration system

2021 ◽  
pp. 23-26
Author(s):  
Serhii TKACHENKO ◽  
Olena POTYSHNIAK ◽  
Yevheniia POLIAKOVA
Keyword(s):  
Quality Assurance ◽  
Production Process ◽  
Cost Management ◽  
Quality Cost ◽  
Cost Of Quality ◽  
Quality Of Work ◽  
Quality Assurance Process ◽  
Assurance Process ◽  
The Cost

Strengthening the impact of the production and economic mechanism on increasing the economic efficiency of the production process and the quality of work is possible on the basis of choosing the most effective ways to achieve high end results of the national economic system of the country. One of these ways is the inclusion in the system of controlled parameters of the economic parameters of quality cost management, the use of which guarantees the quality coordination system to reach a given economically justified state. Adjustment of quality costs consists in maintaining the established proportions between the costs of quality assurance (quality) and the mismatch of work quality indicators, which is achieved by controlling the level of defects, maintaining certain conditions, rules and norms corresponding to the optimal mode of work on quality assurance and the optimal value costs. The quality assurance process is based on a classification represented by a range of activities aimed at ensuring the quality of tools, objects of labour, living labour and information data at all stages of the production process. The costing methodology is based on the selection of the costing object and costing units. Representation of work on quality assurance as an object of calculation, and hours of work or total amount of work as calculation units allows at the right time to present in value terms both the quality assurance process as a whole and the cost of quality for the product. The recommended mechanism of the cost management system in general is focused on a wide range of enterprises and associations, and its use allows to obtain the effect of minimizing the cost of quality, as well as improve the quality of work to ensure product quality, ice directly contribute to production efficiency and quality. Increase of economic benefit at the expense of cost control system solutions of the problem in the future is possible if its implementation on the basis of the theory of functional management development, conversion of static model into a dynamic coordination costs.

scholarly journals Implementation of the Internal Quality Assurance Process: Quality Mapping Analysis at State Senior High School in Tomohon City, North Sulawesi, Indonesia

2020 ◽  
Vol 1 (2) ◽  
pp. 124-133
Author(s):  
Deisy Sampul ◽  
Benny B. Binilang ◽  
J.F. Senduk ◽  
F.J.A. Oentoe
Keyword(s):  
High School ◽  
Quality Assurance ◽  
Senior High School ◽  
Internal Quality ◽  
Quality Of Education ◽  
North Sulawesi ◽  
Quality Assurance Process ◽  
Internal Quality Assurance ◽  
Assurance Process

The Internal Quality Assurance System (IQAS) has an important position in ensuring the quality of education of each education unit. A good internal quality assurance process will guarantee the quality of education is maintained and will make it easier for schools to conduct quality mapping, preparing quality plans, fulfilling quality, evaluating and determining quality standards. The purpose of this study is to describe the implementation internal quality assurance processes at SMAN (State Senior High School) in the City of Tomohon, North Sulawesi based on quality report. This research was designed using qualitative descriptive research with the data collection techniques include observation and documentation as well as data sourced from the Quality Report online application. The results of this study indicate that the internal quality assurance process at SMAN in Tomohon City has been carried out in accordance with national education standards. The educational quality achievement still needs to be improved so that there is consistency in fulfilling quality. In addition, a culture of quality and cooperation must be fostered in order to support the internal quality assurance process. Likewise in the internal quality assurance process that requires support from various elements in the school, government and community environment.

scholarly journals Efektifkah Pelaksanaan Penjaminan Mutu Melalui Akreditasi Lembaga Pelatihan Pemerintah di Indonesia?

2020 ◽  
Vol 16 (3) ◽  
pp. 291-312
Author(s):  
Erna Irawati ◽  
Yogi Suwarno
Keyword(s):  
Quality Assurance ◽  
Educational Institution ◽  
Education And Training ◽  
Competency Development ◽  
Institute Of Public Administration ◽  
Implementation Quality ◽  
Quality Assurance Process ◽  
Assurance Process ◽  
And Training

The implementation of ASN competency development is closely related to the quality of education and training provided by the Educational Institution (Lemdik). The National Institute of Public Administration (NIPA) as the agency assigned the task of fostering the implementation of education and training for ASN employees has conducted quality assurance to ensure the implementation quality of the education and training. Even though quality assurance has been carried out routinely, training problems still arise. This study aims to analyze the implementation of accreditation as a quality assurance process carried out by Educational Institutions. This research was conducted using qualitative descriptive method with data collection techniques through document review, FGDs, and in-depth interviews. The results of the study showed that the implementation of accreditation has not been able to portray aspects of leadership and organizational commitment as part of quality assurance. The results of the study found that the fulfillment of data and information in the implementation of accreditation had not been carried out routinely. From these findings, the results of the study recommended that the quality assurance process must be viewed from the management cycle. Besides, there also needs an improvement in data and information management systems. Keywords: State Civil Apparatus (ASN), Quality Management, Accreditation, Competency Development Abstrak Pelaksanaan pengembangan kompetensi ASN berkaitan erat dengan kualitas penyelenggaraan diklat yang diberikan oleh Lembaga Pendidikan (Lemdik). Lembaga Administrasi Negara (LAN) sebagai instansi yang diberikan tugas dalam membina pelaksanaan pendidikan dan pelatihan pegawai ASN telah melakukan penjaminan mutu untuk menjamin kualitas penyelenggaraan diklat. Meskipun penjaminan mutu telah dilaksanakan secara rutin, tetapi permasalahan diklat masih sering muncul. Penelitian ini bertujuan menganalisis pelaksanaan akreditasi sebagai proses penjaminan mutu yang dilakukan oleh lemdik. Penelitian ini dilakukan dengan menggunakan metode deskriptif kualitatif dengan teknik pengumpulan data melalui telaah dokumen dengan memanfaatkan berbagai dokumen terkait proses akreditasi tahun 2019, FGD, dan wawancara mendalam. Hasil studi menunjukkan bahwa pelaksanaan akreditasi belum mampu memotret aspek kepemimpinan dan juga komitmen organisasi sebagai bagian dari penyelenggaraan penjaminan mutu. Hasil kajian menemukan pemenuhan data dan informasi dalam pelaksanaan akreditasi belum dilakukan secara rutin sehingga menyebabkan data dan informasi yang diberikan cenderung disiapkan hanya untuk keperluan akreditasi. Dari dua temuan ini, hasil kajian merekomendasikan bahwa proses penjaminan kualitas harus dilihat dari siklus manajemen, serta perlu penambahan data dan informasi yang mencerminkan aspek kepemimpinan, integritas dan komitmen pegawai. Selain itu, perlu ada perbaikan sistem pengelolaan data dan informasi untuk menjamin bahwa data yang diunggah benar-benar mencerminkan aktivitas dan penjaminan kualitas di setiap tahapan. Kata kunci: ASN, Manajemen Mutu, Akreditasi, Pengembangan Kompetensi

Quality Assurance as Major Process of Quality Management in Projects

2015 ◽  
Vol 809-810 ◽  
pp. 1305-1310
Author(s):  
Liviu Marius Cîrţînă ◽  
Daniela Cîrţînă ◽  
Angelo Davaris
Keyword(s):  
Quality Assurance ◽  
Quality Management ◽  
Implementation Process ◽  
Industry Standard ◽  
Quality Assurance Process ◽  
Project Idea ◽  
Planning Function ◽  
Assurance Process ◽  
Project Life

Quality management in projects includes the processes necessary for providing the fact that the project satisfies the necessities it had been accomplished for. The quality planning function must remain present throughout the project life cycle. The quality assurance in the projects can be defined as part of quality management in projects that provide confidence that the requirements relating to the quality of the activities carried out in the project will be met. We propose a model in the work for the implementation of the quality assurance process at every stage of a project, from project idea to project results. The proposed model, called PDP/PIP (project definition process/ project implementation process) is described as an application for a project machinery industry standard tools. The outcome of the project quality assurance is a quality improvement plan. This represents a document which is specified actions designed to raise the efficiency of quality management processes in projects and quality of results of the project.

What is clinical audit’s purpose: quality assurance or quality improvement?

2011 ◽  
Vol 2 (2) ◽  
pp. 79-83
Author(s):  
Nancy Dixon
Keyword(s):  
Quality Assurance ◽  
Quality Improvement ◽  
Patient Care ◽  
Clinical Audit ◽  
Audit Process ◽  
Quality Improvement Process ◽  
Quality Assurance Process ◽  
Quality Of Patient Care ◽  
Assurance Process

Clinical audit has become a key activity for healthcare organisations and professionals in England. The clinical audit process is frequently described as a cycle of steps that includes making changes in practice. However, some evidence suggests that clinical audit is not effective in producing improvements in the quality of patient care. The explanation may be that clinicians and managers are seeing clinical audit as a quality assurance process, which implies making small adjustments in practice to conform to standards, rather than as a quality improvement process.

scholarly journals Effectiveness study on applied quality assurance of ducational technology in learning quality improvement in universities

2018 ◽  
Vol 205 ◽  
pp. 00008
Author(s):  
Haryono ◽  
Titi Prihatin ◽  
Ghanis Putra Widhanarto
Keyword(s):  
Educational Technology ◽  
Quality Assurance ◽  
Scientific Discipline ◽  
Learning Problems ◽  
Survey Method ◽  
Learning Technology ◽  
Quality Assurance Process ◽  
Quality Of Learning ◽  
Assurance Process

Educational technology is an applied scientific discipline that develops by the need of the field , namely the demands of learning more effectively, efficiently, broadly, widely, and quickly. As a systematic and systematic process in helping to solve learning problems, the application of educational technology can be directed to the learning quality assurance process. This study is aimed at: (1) analyzing the application of educational technology in improving the quality of learning in universities, (2) analyzing the quality assurance process of learning in universities, and (3) testing the effectiveness of quality assurance models based on applied educational technology in improving the quality of learning in College. The method used is a quantitative approach. The study began with an exploratory survey method, then continued with experiments. The results showed that the analysis of the quality of learning in universities was very dependent on the application of educational technology, the learning quality assurance process agreed that educational technology could improve the quality of learning in universities, and the application of quality assurance models based on applied learning technology is effective to improve the quality of learning in college high. The benefits of this study as a reference for the development model of quality assurance, especially for education and learning.

Quality Assurance of Website Structure

2013 ◽  
pp. 140-148
Author(s):  
G. Sreedhar
Keyword(s):  
Quality Assurance ◽  
Web Site ◽  
Web Design ◽  
Point Of View ◽  
Data Collection Point ◽  
Quality Assurance Process ◽  
And Performance ◽  
Assurance Process ◽  
The Web

Today, the web is not only an information resource, but also it is becoming an automated tool in various applications. Due to the increasing popularity of WWW, one can be very cautious in designing the website. Poor and careless web design leads to hardship to public utility and does not serve the purpose. If the website is not designed properly, the user may face many difficulties in using the website. In last few years a set of website metrics were defined and specified based on the data collection point of view. Among hundred and fifty automated web metrics catalogued up to now, metrics for link and page faults, metrics for navigation, metrics for information, metrics for media, metrics for size and performance, and metrics for accessibility are important categories for evaluation of quality of web site. The website structure and navigation depicts the structure of the website. The navigation of website is dependent on structure of the web site. The present chapter is an attempt to develop a comprehensive quality assurance mechanism towards quality web design process. In this chapter, various measures and metrics for the quality of website structure are investigated as a part of quality assurance process.

A Method for Predicting Wikipedia Editors' Editing Interest

2016 ◽  
Vol 13 (3) ◽  
pp. 1-25 ◽  
Author(s):  
Haisu Zhang ◽  
Sheng Zhang ◽  
Zhaolin Wu ◽  
Liwei Huang ◽  
Yutao Ma
Keyword(s):  
Prediction Accuracy ◽  
Gradient Descent ◽  
Learning Algorithm ◽  
Factor Graph ◽  
Small Scale ◽  
Parameter Learning ◽  
Gradient Descent Algorithm ◽  
Interest Prediction ◽  
Insight Into

Recruiting or recommending appropriate potential Wikipedia editors to edit a specific Wikipedia entry (or article) can play an important role in improving the quality and credibility of Wikipedia. According to empirical observations based on a small-scale dataset collected from Wikipedia, this paper proposes an Interest Prediction Factor Graph (IPFG) model, which is characterized by editor's social properties, hyperlinks between Wikipedia entries, the categories of an entry and other important features, to predict an editor's editing interest in types of Wikipedia entries. Furthermore, the paper suggests a parameter learning algorithm based on the gradient descent algorithm and the Loopy Sum-Product algorithm for factor graphs. An experiment on a Wikipedia dataset (with different frequencies of data collection) shows that the average prediction accuracy (F1 score) of the IPFG model for data collected quarterly could be up to 0.875, which is approximately 0.49 higher than that of a collaborative filtering approach. In addition, the paper analyzes how incomplete social properties and editing bursts affect the prediction accuracy of the IPFG model. The authors' results can provide insight into effective Wikipedia article tossing and can improve the quality of special entries that belong to specific categories by means of collective collaboration.

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