The subject and the research objective presented in this article is establishing of the relationship between quality assurance and implementation of cleaner production in the generic pharmaceutical industry through the comprehensive concept of continuous improvement. This is mostly related to application of Lean and Six Sigma tools and techniques for process improvement and their link to other known concepts used in the industrial environment, especially manufacturing of generic pharmaceutical products from which two representative case studies were selected for comparative analysis, also considering relevant regulatory requirements in the field of quality management, as well as appropriate quality standards. Although the methodology discussed in this conceptual and practice oriented article is strongly related to chemical engineering, the focus is mainly on process industry, i.e. production systems, rather than any specific technological process itself. The scope of this research is an engineering approach to evaluation of the production systems in terms of continuous improvement concepts application, considering both quality aspects and efficiency of such systems. [Projekat Ministarstva nauke Republike Srbije, br. TR 34009]
Current Good Manufacturing Practice (cGMP) being a legal regulation in developed countries will become a legal regulation in Republic of Serbia starting with March 2010. In this paper comparative analysis between requirements of standard ISO/IEC 17025 and requirements of cEU GMP is shown. Considering the fact that in Republic of Serbia no pharmaceutical industry laboratory has been accredited according to requirements of ISO/IEC 17025, while keeping in mind that more than 90% of these laboratories have not fulfilled cEU GMP requirements, this paper aimed at pointing to the possibility of fulfilling both of mentioned requirements at the same time, which would open the way to different types of interlaboratory cooperation for pharmaceutical quality control laboratories and contribute to improving competitiveness of pharmaceutical companies. Accreditation, especially in the case of pharmaceutical quality control laboratories, is important because it guaranties the level of organizational and technical competency. It could easily be said that accreditation is becoming a must in quality control of products in order for the organization to be able to gain a leading role in the global market. Both accreditation and cGMP show the organization's commitment to having products of highest quality level. Considering the above mentioned facts, it is of greatest advantage for pharmaceutical quality control laboratories to fulfill both requirements of ISO/IEC 17025 and cGMP and reach total compliance. The aim of doing this lies in an easier acceptance of pharmaceutical products in different markets, overcoming technical barriers and affirmation of quality as key factor in reaching competitiveness, while keeping in mind the importance of strategic and competitive positioning in the global market
The paper presents an overview of the most important regulations and institutions affecting the level of quality and fittingness of the vehicle fleet, in order to increase the level of general traffic safety in the Republic of Serbia. The Traffic Safety Agency, among other things, alone or in cooperation with others, regulates, controls and implements the system of homologation, testing and control of conformity of vehicles, equipment and parts. It authorizes and supervises other organizations for vehicle control and testing. The role of standardization in this process is dual: first - it refers to the subject of testing - vehicles, and second - to the quality of testing - authorized organizations. The paper discusses the important provisions of regulations for vehicle testing and analyzes the impact of the standards ISO 17020 and ISO 17025 on the work of authorized organizations. In conclusion, it was proposed that in order to achieve and maintain high level of testing quality, mandatory accreditation of authorized organizations should be prescribed. Mandatory application of the standards would have a positive impact on the traffic safety segment which depends on the technical characteristics of the vehicle, and as well, reduce the Agency's obligations.
Akreditacija laboratorije predstavlja potvrdu kompetentnosti laboratorije. Osnovni cilj jeste obezbeđenje poverenja korisnika usluga laboratorijskih ispitivanja u tačnost i preciznost rezultata. Opstanak laboratorije na tržištu, bez obzira da li je ona u potpunosti nezavisna ili je deo većeg poslovnog sistema, u značajnoj meri zavisi od upravljanja resursima, pri čemu je od posebnog značaja efektivno upravljanje troškovima. U radu je prezentiran način obračuna troškova prema unapređenoj verziji obračuna troškova na osnovu aktivnosti-ABC (Activity-Based Costing), koji je afirmisan kao metoda obračuna troškova po aktivnostima zasnovana na vremenu-TD ABC (Time-Driven Activity-Based Costing). Navedena metoda je primenjena u Laboratoriji za fizičko-hemijska ispitivanja u Galenika Fitofarmaciji a.d. u kojoj se sprovode ispitivanja pesticidnih materija (tehničkih materija i gotovih proizvoda). Primenom navedenih metoda moguće je utvrditi realne troškove koji nastaju pri pružanja usluge laboratorijskog ispitivanja, ali i efikasnost pojedinačnih aktivnosti u tom procesu.
In the Balkan region and in the territory of the Republic of Serbia, the energy consumption in relation to gross domestic product is huge. The Republic of Serbia consumes two to three times more energy than the gross domestic product, compared with the average in the European Union. At the beginning of 2013, on the territory of the Republic of Serbia, will be announced the Law on rational use of energy, which is currently in draft form. Adoption of the Law is a step in Serbia's accession to the EU, because the Law will basically have taken a European directive on energy effi ciency. In order to determine the extent to which the concept of energy effi ciency is presented in the formal and informal education, as well as knowledge of this area in general, the survey was done. This paper describes a results of survey that was done with the aim of gaining information about education in the fi eld of energy effi ciency in formal and informal education systems in Serbia, as well as how much are the citizens familiar with the term. This paper shows the questionnaire which was distributed to the respondents. For easily and quickly collecting the necessary data, it was used the on-line questionnaire. The questionnaire was designed as a web application. The survey was conducted on a sample of 200 respondents, from September to December 2012. After the structure of the respondents, the results of research and analysis are presented in this paper, with one proposed research in future.
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