scholarly journals Process validation: An essential process in pharmaceutical industry

2015 ◽  
Vol 1 (4) ◽  
pp. 179
Author(s):  
Brahmaiah Bonthagarala ◽  
Sandhya Ch. ◽  
Pusuluri Dharani Lakshmi Sai ◽  
Konkipudi Venkata Sivaiah

The purpose of this work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process with special reference to the requirements stipulated by the US Food and Drug Administration (FDA).Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.

Author(s):  
H Aleem ◽  
Y Zhao ◽  
S Lord ◽  
T McCarthy ◽  
P Sharratt

Drugs are critical elements in health care. They must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used. In the pharmaceutical industry, process validation performs this task, ensuring that the process does what it purports to do. It is also a regulatory requirement. This paper presents an introduction and general overview of this process, with special reference to the requirements stipulated by the US Food and Drug Administration (FDA).


2021 ◽  
Vol 12 (10) ◽  
pp. 23-26
Author(s):  
M Mohankumar ◽  
G Sivakamasundari

Validation is a notable step in fulfilling and keep the character of the last decision. In the event that every progress of the creative process is recognized, we can guarantee that the end result will be of the best quality. Validation is specialized for planning and rehearsing a closely planned step with documents. Verification and quality assurance are inseparable, which guarantees careful quality of products. The process validation underscores the components of the measurement scheme and adheres to the measurement control during commercialization and realizes that it is nothing more than a continuous program and adjust the measurement validation exercises with the item life cycle. The motivation behind this survey is to introduce a presentation and general disclosure on quantitative validation of pharmaceutical production with a unique note to the requirements specified by the US Food and Drug Administration (FDA).


2017 ◽  
Vol 11 (2) ◽  
pp. 277-292
Author(s):  
Aep Kusnawan ◽  
Arif Rahman ◽  
Dede Lukman ◽  
Encep Dulwahab

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.


Author(s):  
Amitava Mitra

As the competition for products and services continues to grow, with customer satisfaction playing an integral part in this process, organizations are faced with the task of ensuring quality in all of their activities. Since many organizations do not necessarily produce the entire product or deliver the service by themselves, they are dependent on other vital sources, for example, suppliers, that impact quality of the finished product/service. This necessitates development and implementation of a quality management system which can integrate information from the various entities to facilitate decision making in a timely manner. Additionally, it is desirable for such a quality management system to be responsive to the existing quality environment at the various sources that contribute to the manufacture of the product or delivery of the service. This chapter provides a foundation for accomplishing such quality management objectives.


2020 ◽  
Vol 8 (1) ◽  
pp. 189-201
Author(s):  
Ana-Marija Vrtodušić Hrgović ◽  
Kristina Črnjar ◽  
Ivana Škarica

Quality assurance in public health presents one of the key factors in the quality of health service. Accordingly, there is increasing awareness of the need to integrate quality systems and their principles into the healthcare system. Their role is important in the context of quality assurance in accordance with patient requirements as well as in the process of improving the quality of health care service. They are essential for the successful implementation of a quality management system and refer to customer focus, leadership, engagement of people, process approach, improvement, evidence–based decision making, and relationship management. This paper presents the results of a study among Croatian Institutes of Public Health with regard to the level of implementation of quality principles related to employee engagement, improvement and internal customer focus. Analysis focused on the relationship between focus on internal customer (employees) and improvements as well as the employee engagement and improvement respectively. Results show there is a strong positive relationship between employee engagement and improvements, while between internal customer focus and improvement the relationship has not been verified. In the context of standardization of quality of public health services, the paper aims to expand theoretical knowledge about TQM principles, with the emphasis on the employee engagement, internal customer focus (employees) and process improvement. The results can serve as a basis for improving the existing practice of quality management system implementation in the public health sector, with emphasis on employees.


2020 ◽  
Vol 164 ◽  
pp. 09027
Author(s):  
Olga Safonova ◽  
Lyudmila Tatarnikova

The model of a quality management system based on international standards ISO 9000 series is recognized in all the world. The aim of the article is to show the competitive advantages of a construction company in the modern market by improving its quality and product management system. We consider the implementation of the provisions of international standards ISO 9000 series as an effective solution to the problem. Quality improvement is a continuous work aimed at improving the technical level of product quality, quality of its manufacture, improving production elements and the quality system itself. The authors of the article give a specific method for improving the enterprise quality management system with a developed sequence. A risk-based approach to creating an enterprise quality management system was also considered. The main research methods in assessing the technical condition of certain building materials are differential, integrated and mixed methods. The authors show the calculation procedure using these methods, as well as the main results of their application. Then, the article provides a methodology for calculating the level of product quality, which is evaluated by a set of indicators, which do not include economic indicators.


2020 ◽  
Vol 22 (1) ◽  
pp. 66-78
Author(s):  
Igor Stoyko ◽  
Roman Sherstiuk

The possibility of implementing a quality management system in the hotel and restaurant complex of Ukraine based on the William Edwards Deming’s principles of quality management to meet the requirements of ISO 9000 quality standards and Hazard Analysis and Critical Control Points (HACCP) is substantiated in the article. The purpose of the study is to adapt the William Edwards Deming’s principles of quality management to their implementation in the hotel and restaurant business to ensure the stability of services quality in the modern market, the orientation of managers on creation of conditions for the enterprise’s continuous improvement. Standard DSTU ISO 9000-2015 "Quality management systems. Fundamentals and vocabulary" provides seven general principles of quality management, specific to all activities: customer focus, leadership, employee engagement, process approach, improvement, decision-making based on evidence, relationship management. Ensuring these principles makes it possible to manage the quality of enterprises, including the hotel and restaurant industry. The quality management of hotel and restaurant services is considered as a set of interconnected subjects, objects, principles, methods and functions of management, focused on the development and satisfaction of quality requirements and reduction of its costs. Ukraine has a significant potential in the development of hotel and restaurant services. The expansion of the hotel and restaurant business infrastructure is required as well as the establishment of institutions for employees’ training and retraining. The priority is to develop the country’s own regulatory framework that would regulate the quality of services in this area. The quality management system of hotel and restaurant services must guarantee the customer’s requests satisfaction while being served in the hotel and restaurant at all stages and at all levels. Therefore, the issue of development and practical application of the enterprises’ internal standards which determine the general components of the hotel and restaurant services quality is of great importance.


2021 ◽  
Author(s):  
◽  
Godwin Utuka

<p>This research involves a comparative analysis of Ghanaian and New Zealand contexts and provisions of quality assurance in tertiary education. The study examined policies and practices of quality assurance in higher education in Ghana and New Zealand in order to identify those practices in New Zealand which are potentially applicable to the Ghanaian Higher Education context or which, at least, may suggest a direction for the Ghanaian government to consider for development. This study argues that although the management and practices of quality assurance in higher education in New Zealand are not without flaws, Ghana stands a better chance of tapping from the formers’ experiences in shaping its future policy direction. The quality of higher education and its improvement have always been issues of high priority on the political and educational agendas of the government and higher institutions in Ghana. Like other developing nations, Ghana has adopted various methodologies to address the question of quality in higher education similar to those in Western countries. The government of Ghana established a national quality assurance agency, the National Accreditation Board (NAB) to be responsible for quality assurance in higher education. Higher educational institutions have also adopted various processes and practices for the assurance of quality of the education provided. However, despite the fact that the literature on quality assurance framework in higher education is growing, little is available in the literature on what Ghana is doing to regulate and improve higher education quality and what has been the impact of NAB since its inception in 1993. In addition, a formal study of the commonality or diversity of approaches between Ghana and any developed nation has been lacking. A qualitative methodology was used to gain the perceptions of key practitioners in quality management systems in the two countries. Interview and documentary analysis were the main research instruments employed for data collection. The study analysed the views of a range of respondents from Ghana and New Zealand and documents from selected tertiary institutions and external quality assurance agencies in the two countries. A comparative analysis of data revealed some gaps and challenges in the Ghanaian system. This study found that though NAB has made significant impacts on the quality regime of the higher education sector in Ghana since its inception, the processes of quality management demands remains a challenge to both the institutions and NAB and much remains to be done for improvement. Quality of provision at the institutional level (internal structures, documented policies, external involvement, conduct of self assessment), and at the national level (regular monitoring, change in compliance approach, adequate qualified staff etc) are key areas requiring urgent policy attention if Ghana is to achieve the objectives of its tertiary educational reforms. On the basis of empirical evidence and life experiences from the respondents, a contribution would be made to the design of higher education policy-making with regard to the improvement of the internal and external quality assurance practices in higher education in Ghana. This study has further contributed to quality assurance literature by critically examining and comparing life responses of respondents from two countries viv-a-vis the international trend before making its recommendations. This study has further deepened the understanding of quality management practices in higher education in the two countries involved in this study.</p>


2020 ◽  
pp. 102-108
Author(s):  
Ольга Володимирівна Нємченко ◽  
Альона Юріївна Кисилевська ◽  
Віталій Леонідович Костенко

In recent years, the security and defense sector of Ukraine has been undergoing reforms aimed at gaining the country's membership in the NATO North Atlantic Treaty Organization. One of the many aspects of these reforms is the introduction of some specific standards, in particular, the AQAP 2000 series standards in the quality management systems of military equipment enterprises. In the case of implementation of several international standards at the enterprise, there is a need to create integrated quality management systems. The article presents options for implementing two or more standards in the QMS of the enterprise, analyzes their disadvantages and advantages. The main requirements of the AQAP 2110 standard, which should be integrated with the requirements of the ISO 9001 standard in the context of the PDCA cycle ("Plan-Do-Check-Act"), are considered. The stages of the implementation of integrated QMS are described. The scheme of deliveries of products to the customer in which there is a certification of the quality management system of the manufacturer (supplier) by the external body on conformity assessment, control over the quality of production by military representation, and the government quality assurance GQA has resulted. Government quality assurance GQA means that the authorized national body carries out the process of assessing the conformity of the quality management system of the manufacturer (supplier) to the requirements of ISO 9001 and NATO standards AQAP 2000, which allows the customer to gain confidence in the quality of defense products. A special requirement is to draw up a Quality Plan, which defines the activities, processes, resources, responsibilities of the manufacturer, etc., to convince the customer and the GQA representative that the company can manufacture and supply products of appropriate quality and on time, because in case of defective products or failure to deliver is lost time for a replacement or waiting, and this is a constant risk to the country's combat readiness. Requirements for the content and design of the Quality Plan are given in the standard AQAP 2105. In addition to the above, the following specific requirements of AQAP 2110 are analyzed as the operation of the metrological support system at the enterprise according to DSTU ISO 10012, product configuration management with software according to ACMP 2100, risk management, etc.


2020 ◽  
Vol 64 (6) ◽  
pp. 311-317
Author(s):  
Dmitry A. Andreev ◽  
Aleksandr A. Zavyalov ◽  
Asan Yu. Kashurnikov

Introduction. Quality assurance plays a pivotal role in the health industry. The countries of Western Europe demonstrate good outcomes of cancer care. The purpose of the study. This paper focuses on various backbones of quality assurance systems in oncology in Belgium, Germany, and the Netherlands. Material and methods. Authors retrieved information from PubMed (Medline), Google, and public websites. The key phrases related to the organization of quality management systems for cancer care were used. About 40 informational sources were selected, including scientific articles and media. Discussion. All reviewed countries equipped with the quality management structures affecting such cancer care aspects as: •Creating regulatory acts and policy for next-generation healthcare in oncology; •Employing the top-qualified personnel; •Updating the clinical guidelines and improving medical processes; •Organizing the cyclical processes for monitoring the quality of cancer care and patient needs; •Implementing the innovations; •Implementing the principles of «transparency» in assessing the quality of cancer care. Conclusion. It seems logical to further study Western Europe’s experience in developing quality management systems for cancer care.


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