scholarly journals The development of an algorithm of introduction of new drug on the existing pharmaceutical production. Stage 2. Transfer of technologies

2020 ◽  
Author(s):  
Anna Bacevich ◽  
Anatoliy S. Dzjuba ◽  
Irina E. Kaukhova ◽  
Alexandra Tretiakov
Keyword(s):  
Control Methods ◽  
Material Resources ◽  
Project Activity ◽  
New Drug ◽  
Transfer Of Technology ◽  
Preparatory Stage ◽  
Quality Of Products ◽  
Pharmaceutical Production ◽  
And Control

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.

A REVIEW ON PHARMACEUTICAL VALIDATION AND ITS IMPORTANCE AND IMPUTATION

2021 ◽  
Vol 12 (10) ◽  
pp. 23-26
Author(s):  
M Mohankumar ◽  
G Sivakamasundari
Keyword(s):  
Quality Assurance ◽  
Creative Process ◽  
Process Validation ◽  
The Us ◽  
Measurement Control ◽  
Quantitative Validation ◽  
Measurement Validation ◽  
Quality Of Products ◽  
Pharmaceutical Production

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).

scholarly journals A Novel Transportation Method Based on Dynamic Control of Ripening Environment

2020 ◽  
Vol 13 (5) ◽  
pp. 58-66
Author(s):  
Xinyu Liu ◽  
◽  
Xiaojie Jin
Keyword(s):  
Low Temperature ◽  
Fruits And Vegetables ◽  
Control Method ◽  
Volume Fraction ◽  
Dynamic Control ◽  
Exogenous Ethylene ◽  
Quality Of Products ◽  
And Control ◽  
Air Circulation

The dynamic control of atmosphere is an important factor for guaranteeing the quality of climacteric products during transportation. As atmosphere changes, respiration climacteric products would rot because of overripeness, thus leading to loss. Moreover, climacteric products must be ripened artificially when delivered to the destination, thereby causing economic waste. In this study, a new transportation method based on dynamic control of ripening environment was designed.The ripeness control method based on the dynamic control of ripening atmosphere was presented to accomplish quality safety during transportation as well as avoid a subsequent extra process of ripening. The transportation method was employed to stem from the ethylene’s ripening effect on climacteric fruits and vegetables. The ethylene generator and air circulation unit, which dynamically regulate and control the dual regional atmosphere of carriages during transportation, were quantitatively controlled by the central treatment layer. Ripeness level could be regulated by controlling the temperatures and time of exogenous ethylene release, to control the quality of products and ripen them. The proposed method was proven feasible through experiments. Results demonstrate that a volume fraction of 0.01% exogenous ethylene allows bananas’ respiratory intensity to reach the peak early; meanwhile, moderate low temperature (16 °C) can enable ethylene peak to appear in advance. Therefore, bananas’ ripeness can be controlled by changing temperatures and the ripening environment when transporting. This study can provide references for the control of products’ ripeness during transportation.

scholarly journals Green Quality Improvement Using Six Sigma Method

2020 ◽  
Vol 5 (8) ◽  
pp. 583-588
Author(s):  
Sutrisno Harianto ◽  
Ellysa Nursanti
Keyword(s):  
Quality Improvement ◽  
Six Sigma ◽  
Raw Materials ◽  
Improvement Method ◽  
World Class ◽  
Quality Of Products ◽  
And Control ◽  
Level 2 ◽  
Quality Improvement Method

Traditional cast brass handicrafts Majapahit is one of the nation's cultural heritage which has a high historical value. The uniqueness and quality become the hallmark of this craft products. The results of handmade products such as sculptures, wall hangings, souvenirs, ornaments doors and so on. To increase the sales of traditional handicrafts of brass castings, required Majapahit applicative technical efforts in improving the quality of products which are ecofriendly. Quality improvement method such as Six sigma. Six sigma focuses on decreasing flawed rate, by reaching the standard 3, 4 flawed in a thousand possibility. Six sigma has 5 phases; define, measure, analyze, improvement, and control. In this research, six sigma is applied in producing cast brass handicraft starting from making the master mold, preparation of smelting raw materials, cooling process, releasing of the mold, and finishing. Purposefully to improve the quality by overcoming and decreasing the high of flawed possibility and also applying marketing mixture in improving the market segmentation of traditional cast brass of Majapahit market. The result is quality improvement is shown by decreasing happen in number of flawed product in total of mean for about 154, 8 decreased to 59,5. While the calculation of the six sigma, flawed product of cast brass handicraft is for about 1,7625 sigma value or being in level 2 and increased to 3,725 or being in level 4 with the flawed possibility in amount 235,000 for thousand times of production. The ability of production for the requirement which is wanted by the consumers and owning a good enough capability but still needed some correction to achieve world class home industry

System-process analysis of quality

2017 ◽  
Vol 14 (4) ◽  
pp. 39-46
Author(s):  
D. N. Kalacheva
Keyword(s):  
Process Analysis ◽  
Quality Characteristics ◽  
Hierarchical Decomposition ◽  
System Process ◽  
System Method ◽  
Form Quality ◽  
Quality Of Products ◽  
And Control ◽  
Required Quality

The system method of hierarchical decomposition and subsequent composition is widely used in practice. However, decomposition does not simplify, but even complicates the analysis of quality, since it is necessary to investigate, in addition to the object itself, all the selected subsystems and elements, which as integral patterns are characterized by their properties and connections. To ensure the required quality of products, it is necessary to consider and control not only the properties of the result (element, subsystem, product), but also all processes that form quality characteristics.

scholarly journals Ensuring food security and control of sheep and goat scrapie

2020 ◽  
Vol 210 ◽  
pp. 06020
Author(s):  
Nadezhda Taranukha ◽  
Yuliya Bezgina ◽  
Natalia Fedota ◽  
Eduard Gorchakov ◽  
Nadezhda Ozheredova ◽  
...  
Keyword(s):  
Food Security ◽  
Clinical Characteristics ◽  
Infected Animal ◽  
Animal Disease ◽  
Standard Methods ◽  
Long Time ◽  
Quality Of Products ◽  
Definition Of ◽  
And Control

In this paper, we consider the control of animal carcasses and the detection of such a disease as scrapie. For our country, this animal disease remains quite rare, but at the same time it should not be overlooked. This is due to the fact that there are regular purchases of breeding cattle from abroad, and this is a risk of importing an infected animal. The relevance of the work is that the disease of sheep and goats-scrapie can not be detected at very early stages of its development. Symptomatic manifestations do not appear immediately, there are no clear clinical characteristics, which is why this disease can not be diagnosed for a long time. To assess the health status and predict the quality of products obtained, new approaches are needed to study the products of sheep and goat slaughter. Great importance is given to standard methods of studying, identifying certain patterns in clinical, anamnestic, morphological, metric and anatomical indicators of the animal body. Using these indicators and changing their dynamic characteristics, it is possible to make significant adjustments in the definition of this disease, which would allow us to develop a number of rules for modern veterinary and sanitary evaluation of animal slaughter products.

scholarly journals Science and Technology for the Export Product of Small and Medium Sized Enterprise (UKM) Kotaraja Rattan

2019 ◽  
Vol 7 (3) ◽  
pp. 551
Author(s):  
Ully Muzakir
Keyword(s):  
Product Quality ◽  
Production Management ◽  
Raw Materials ◽  
Science And Technology ◽  
Industrial Society ◽  
Transfer Of Technology ◽  
Quality Of Products ◽  
Export Product ◽  
Banda Aceh

The objective of the Export Product Science and Technology Division (IBPE) is to boost the export growth of Small and Medium Sized Enterprises (SME) of rattan handicraft products in Aceh Besar Regency "Kotaraja Rotan" through improved management and product quality. The program also aims to accelerate the transfer of technology and management from STKIP Bina Bangsa Getsempena Banda Aceh as the implementer of IBP to SME "Kotaraja Rotan" as an industrial society as well as developing link and match between STKIP Bina Bangsa Getsempena Banda Aceh, SME, Aceh Besar District Government and large community. The method implemented is to provide assistance to the quality of raw materials, production processes, product quality, production management and marketing, quality of manpower, facilities and finance of SME. The conclusion of the program in this first year is the solution offered has successfully solved the problems faced by partners that are marked with the issuance of business license for partners, the availability of mall tools to guarantee the quality of products concerning the size and shape, availability of production space and good and clean showroom with partner needs. This IbPE program has encouraged the public spirit to be able to produce export products in order to compete in the international market.

UNCERTAINTY ESTIMATION OF THE STRAIN GAUGES CONFIGURATION

2021 ◽  
pp. 46-51
Author(s):  
O. V. Goryunov ◽  
S. V. Slovtsov
Keyword(s):  
Quality Measurement ◽  
Theory Of Elasticity ◽  
Pressure Vessels ◽  
Measuring Channel ◽  
Strain Gauges ◽  
Operational Tests ◽  
Quality Of Products ◽  
Full Scale Tests ◽  
And Control

The trend of improving the quality of products in the field of energy is aimed, in particular, at improving the quality of validation and verification of the declared parameters (strength of industry and research nuclear reactors and other pressure vessels, etc.). For verification of the parameters of the integrity and strength within the plant and operational tests and control the operating parameters using high-quality measurement and control equipment, which is part of the measuring channel. Improving the quality of the information is obtained, in particular, during full-scale tests using strain gauges, leads to an increase in the quality of products in general. The measurement result depends on many factors, which are not always possible to control due to technical and economic reasons. Using the apparatus of mathematical analysis and the theory of elasticity, it is shown that one of the parameters – the configuration of the strain gauge can reduce the uncertainty of the results of measurements by tensometric methods.

scholarly journals Unique Factors of Best Value Procurement from the Perspective of Nigerian Construction Professionals

2020 ◽  
Vol 7 (2) ◽  
pp. 1-14
Author(s):  
Gumgaro Simon-Peter Buba ◽  
Razali Adul Hamid ◽  
Zuhaili Mohamad Ramly ◽  
Tchad Sharon Jatau ◽  
James David Jatau
Keyword(s):  
Construction Industry ◽  
Cost Effective ◽  
Best Interest ◽  
Best Value ◽  
Quality Of Products ◽  
Procurement System ◽  
Procurement Method ◽  
And Control ◽  
Poor Working Condition

The construction industry is vital to the economic development of any country. It has a major role in providing built infrastructures in an innovative and cost-effective way using an effective procurement approach. In contrast, the most widely used procurement method in Nigeria is the traditional procurement approach which is known for plaguing the industry with the poor working condition and poor performances thus, reducing the sustainability and quality of products and services. For this reason, there is a need for a procurement approach which utilises expertise to minimise the risk of non-performance and create a win-win environment for both client and contractors, while increasing transparency and add value to the project such like, the Best Value Procurement. Against the background, this paper aims to establish the perception of the Nigerian construction professionals on the unique factors of the Best Value Procurement. The paper outlines the following objectives: To identify the unique factors of the Best Value Procurement and, to establish the perception of the Nigerian construction professionals on the Best Value Procurement unique factors. Using a questionnaire survey, data was collected form 314 construction professionals involving Quantity Surveyors, Architects, Builders and Civil Engineers. Kruskal Wallis Test and mean score ranking was used for data analysis. The findings show that the professionals generally agree that the Best Value Procurement unique factors can bring about transparency, accountability, increase project performance and the contractor is the best to control risk and adds value to the project. This paper derives its significance from the need to stabilise the procurement system in Nigeria by transferring the risk and control to contractors who must act in the best interest of the client. 

scholarly journals Improving the Manufacturing Process of Aluminium Rims

2021 ◽  
Vol 3 (1) ◽  
pp. 38-46
Author(s):  
Czerwińska Karolina ◽  
Pacana Andrzej
Keyword(s):  
Mechanical Properties ◽  
Quality Management ◽  
Human Resources ◽  
Diagnostic Process ◽  
Material Structure ◽  
Front Edge ◽  
Sequential Method ◽  
Quality Of Products ◽  
And Control

Abstract The aim of the study was to indicate the reasons for non-compliance of aluminium rim castings and, using quality management instruments (Pareto-Lorenzo diagram and 5WHy method?), elimination or reduction of non-compliant products. The object of the research was an aluminium rim, while the diagnostic process of the object of the research was based on the quality control of the chemical composition of the casting, the control of mechanical properties and the control of the continuity of the material structure by radiographic and microscopic methods. On the basis of the research carried out, it was found that a sensitive casting area is the front edge of the rim rim - a significant number of porosity clusters were identified in this area. The reason for their occurrence was also specified - too rapid flooding of moulds, which resulted in gassing of the alloy. The identified cause had its origins in human resources mismanagement, namely the lack of training of the newly recruited employee. So far, the company has not carried out analyses of quality problems with the use of a sequential quality management methodology, so the implemented corrective actions have not always led to the full achievement of quality objectives. The presented sequential method, which is a combination of diagnostic and control tests and quality management instruments, is a universal way to monitor the level of quality of products and to quickly correct nonconformities.

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