2021 ◽  
Vol 12 (10) ◽  
pp. 23-26
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).

2015 ◽  
Vol 1 (4) ◽  
pp. 179
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.

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).

2019 ◽  
Vol 3 (1) ◽  
pp. 33
Roza Thohiri ◽  
Andri Zainal ◽  
Pasca Dwi Putra ◽  
Joko Suharianto

The activities of the CPM with the title of “the Actualization of the Improvement of the Competitiveness of the Product Oil Scrub Traditional Herbs Through Branding and Certification Guarantee the Quality of Products UMK Rambal Deli in District Girders” this is focused on penuntasan 3 (three) problems specific be problem specific namely (1) Absence of the actualization of the knowledge explicit (explicit knowledge) in the product oil rub the traditional herbs that is produced; (2) product competitiveness the relative weakness with the management of production, marketing and finance is still traditional and; (3) the Body efforts yet there the body order official and permit the efforts which have not yet registered. Partners involved in the activities of the CPM this is the UMK Rambal Deli led by Mr. Agus Hidayat. UMK is located in the Street Sergeant M. Arifin gg. Muslim Lk. II wards Girders of the City, Subdistrict Girders, Regency of Deli Serdang. As an alternative solution for the settlement of the problem referred to consists of: (1) documentation of the profile and the formula of the products in print and electronic; (2) modernization and amplification of diffuse marketing: finishing and marketing system, and; (3) the assitance management certificate stand SME and business licenses. The activities of the CPM this will produce some external of them: The Proceedings, the Application of ABOUT and Product Innovation, draft pocket book, assitance management certificate stand order and clearance order.Keywords: SME, Certificate of Incorporation, Business license, Packaging.

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Carine Glaucia Comarella ◽  
Taísa Ceratti Treptow ◽  
Álisson Santos de Oliveira ◽  
Eliseu Rodrigues ◽  
Claudia Kaehler Sautter ◽  

PurposeThe aim of this study was to evaluate the effect of ultrasound (US) treatment on the postharvest of “Isabella” grapes and the consistency of the obtained results regarding the composition of anthocyanins in grape juice over three successive harvest years using a combination of analytical techniques.Design/methodology/approachJuices produced from “Isabella” grapes sonicated for different durations (3, 5, 7 and 10 min) were analysed. The grapes were harvested and sonicated in 2013, 2014 and 2015, and each treated sample was stored for 1, 3 and 5 days in order to verify the time necessary for the development of the US response. The juices were analysed through physicochemical analysis (total monomeric anthocyanins). The anthocyanin profiles were quantified and identified using high performance liquid chromatography coupled to photodiode array and mass spectrometry detectors (HPLC-PDA-MSn).FindingsThe results demonstrated the potential of US in improving the quality of grape juice. In all three harvests, it was observed that the treatments were effective in increasing the concentration of anthocyanins. For the 2013 harvest, the application of US for 5 min led to a 103% increase in juice pigments. However, the US response profile varied among the three harvests, indicating that the US effect was influenced by the ripening conditions of the fruit. In total, 33 anthocyanins were identified in the grape juice. For the first time, peonidin-3-p-coumaroyl glucoside-5-glucoside was identified in “Isabella” juice.Originality/valueThe results of this study validated US treatment as a simple and effective physical method that can be used as an alternative technology for improving the general quality of products such as juice by increasing the pigment concentrations that are linked to the colour and antioxidant potential of drinks. Moreover, the results demonstrate that US treatment may be less effective in the case of a sample with distinct phenolic maturation.

2021 ◽  
Vol 11 (1) ◽  
pp. 556-569
Febrian Isharyadi ◽  
E. Kristiningrum

Abstract Quality is a universal standard that is expected by consumers of a product or service used. Consumers in general cannot individually assess this quality, with the help of an independent third party it can be done. The certification body is one element in the quality infrastructure that plays a role in providing quality assurance of products and services according to applicable standards. There are various certification bodies in Indonesia both for system and product certification, the kinds additionally range in accordance to the scope of certification. However, it is not yet known generally the condition of the system and product certification in Indonesia. The aim of this study is to conduct profiling and analyse the condition of the system and product certification in Indonesia using a comprehensive tool in order to assess part of the quality of a country's infrastructure. The results showed that there were several elements that were fulfilled, especially in terms of legality and national recognition. However, some elements still need improvement so that the certification body can do its part to ensure the quality of products and services.

Т.С. Огурцова ◽  
Н.П. Асташева

В работе рассмотрены основные цели и задачи оценки эффективности деятельности организации по обеспечению качества ракетно-космической техники. Представлены результаты расчета показателей эффективности деятельности «КБхиммаш им. А.М. Исаева» по обеспечению качества продукции в 2019 году с использованием методики СТО ГК Роскосмос 1023-2019. Показано, что рассмотренная в статье методика позволяет проводить оценку эффективности деятельности «КБхиммаш им. А.М. Исаева» и разрабатывать рекомендации по повышению качества выпускаемой продукции. The paper considers the main goals and objectives of assessing the effectiveness of an organization to ensure the quality of rocket and space technology. Presented are the results of calculating the performance indicators of «KBhimmash im. A.M. Isaev» to ensure product quality in 2019 using the methodology of the STO GK Roscosmos 1023-2019. It is shown that the methodology considered in the article makes it possible to assess the effectiveness of the activities of «KBhimmash named after A.M. Isaev» and develop recommendations for improving the quality of products.

2020 ◽  
Vol 4 (1) ◽  
pp. 19-24
Nodir Nizomovich Avliyakulov ◽  
Sadriddin Ubaidilloevich Rukhilloev

Improving the efficiency of production and quality of products is possible only with the organization of modern metrological support. The paper presents measures and tasks concerning metrological support of production at the stages of design, development, production and testing, contributing to the production of quality products. To fulfill the tasks assigned to the metrological service, it must have a position, structure, quality assurance system, personnel, necessary premises, conditions for the operation and storage of measuring instruments.

2020 ◽  
Anna Bacevich ◽  
Anatoliy S. Dzjuba ◽  
Irina E. Kaukhova ◽  
Alexandra Tretiakov

Transfer of technologies is a logical, controllable and documented procedure of transfer of technology and control methods of medicine from the developer to the producer or from one producer to another [1]. A lot of departments of the enterprise involved in this process, their organization and coordination of work determines the character, timeliness and completeness of the transfer that has a direct influence on the quality of products. The task of the company in transfer of technologies is to preserve the quality of products and compliance with GxP rules, while material resources, time and space of the enterprise are economizing. Transfer of technologies divides into a preparatory stage and two main stages. The universal algorithm of the project of transfer of technology for the introducing a new drug at the operating enterprise is developed, the system of the organization of control and risk assessment of project activity is defined.

2021 ◽  
pp. 18-21
Serhii TKACHENKO ◽  

Improving the quality of finished products, as well as its provision, associated with costs at all stages of the production process of finished products, in the pre-production and post-production periods. The cost of quality assurance at the stage of the production process occupies a special place in the total cost of quality. Difficulties in estimating the cost of product quality assurance are that there is no experience in determining the production costs of quality assurance of finished products and that the number of influencing factors that must be taken into account in the manufacture of final products of a given level of quality in mass production. Ensuring the quality of products requires significant costs, which over time, given the growing requirements for the quality of finished products, will grow, which determines the need to develop a mechanism to link quality management of finished products with normalized costs to ensure its quality. An article devoted to this little-studied problem and aims to outline theoretical, methodological and practical ways to manage the cost of quality, their coordination in terms of ensuring a given level of quality of finished products. The problem of coordinating (managing) the costs of quality is dictated by the need to include in the case all the reserves and opportunities to improve efficiency and quality, including the ability to correctly calculate, analyze, evaluate and compare costs and results. The purposes of the article, justifying the need for an interdependent system of quality management indicators, is in line with the objectives of resource conservation, a sharp increase in economic efficiency of the production process and improve the quality of products. The scientific problem understood the role as the costs inflicted rocker economic (economic) efficiency mode of operation of the quality management system of finished products, the algorithm definition, calculation methods, detection, calculation, forecasting and control(coordination) costs of product quality.

2019 ◽  
Vol 3 (1) ◽  
pp. 47
Yohana Sutiknyawati Kusuma Dewi

The second year of Ipteks bagi Desa Mitra (IbDM) programs have been done at Lingga village Kubu Raya Regency. The aims of this programs were preparing of human resources able to produce cracker products according to SNI and its packaged with labels so that its was increasing of her family income. The target audience in the second year was a member of the PKKs of Lingga Dalam and Remaja Masjid group. The method was used evaluation and socialization, assistance, evaluation and monitoring. The cracker quality assurance is enhanced through production system by semi-mechanical cracker slicers and solar dryers. The two devices to produce crackers that its have uniform thickness and safety of contaminants during drying. Quality assurance is also carried out by enhancing the administration of both the production and marketing of crackers. The entire IbDM programs has an impact on improving the quality of products, partner income and consumer confidence.     Keywords: PPM, IbDM, Crackers, Lingga, quality

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