TY  - JOUR
AU  - Boltić, Zorana
AU  - Jovanović, Mica
AU  - Petrović, Slobodan
AU  - Božanić, Vojislav
AU  - Mihajlović, Marina
PY  - 2016
UR  - http://TechnoRep.tmf.bg.ac.rs/handle/123456789/3449
AB  - 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.
PB  - Savez hemijskih inženjera, Beograd
T2  - Chemical Industry & Chemical Engineering Quarterly
T1  - Continuous improvement concepts as a link between quality assurance and implementation of cleaner production - case study in the generic pharmaceutical industry
EP  - 64
IS  - 1
SP  - 55
VL  - 22
DO  - 10.2298/CICEQ150430019B
ER  - 

@article{
author = "Boltić, Zorana and Jovanović, Mica and Petrović, Slobodan and Božanić, Vojislav and Mihajlović, Marina",
year = "2016",
abstract = "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.",
publisher = "Savez hemijskih inženjera, Beograd",
journal = "Chemical Industry & Chemical Engineering Quarterly",
title = "Continuous improvement concepts as a link between quality assurance and implementation of cleaner production - case study in the generic pharmaceutical industry",
pages = "64-55",
number = "1",
volume = "22",
doi = "10.2298/CICEQ150430019B"
}

Boltić, Z., Jovanović, M., Petrović, S., Božanić, V.,& Mihajlović, M.. (2016). Continuous improvement concepts as a link between quality assurance and implementation of cleaner production - case study in the generic pharmaceutical industry. in Chemical Industry & Chemical Engineering Quarterly
Savez hemijskih inženjera, Beograd., 22(1), 55-64.
https://doi.org/10.2298/CICEQ150430019B

Boltić Z, Jovanović M, Petrović S, Božanić V, Mihajlović M. Continuous improvement concepts as a link between quality assurance and implementation of cleaner production - case study in the generic pharmaceutical industry. in Chemical Industry & Chemical Engineering Quarterly. 2016;22(1):55-64.
doi:10.2298/CICEQ150430019B .

Boltić, Zorana, Jovanović, Mica, Petrović, Slobodan, Božanić, Vojislav, Mihajlović, Marina, "Continuous improvement concepts as a link between quality assurance and implementation of cleaner production - case study in the generic pharmaceutical industry" in Chemical Industry & Chemical Engineering Quarterly, 22, no. 1 (2016):55-64,
https://doi.org/10.2298/CICEQ150430019B . .

TY  - JOUR
AU  - Boltić, Zorana
AU  - Ružić, Nenad Lj.
AU  - Jovanović, Mica
AU  - Mihajlović, Marina
AU  - Jovanović, Jovan
AU  - Petrović, Slobodan
PY  - 2013
UR  - http://TechnoRep.tmf.bg.ac.rs/handle/123456789/2519
AB  - The aim of the article is to present a case study related to implementation of cleaner production (CP) process with the concept of minimizing emissions versus the end of pipe (EOP) approach within pharmaceutical industry. The idea is to move beyond simple pollution control by technology improvement and prevention of organic solvents emission into the atmosphere. Furthermore, cost-effectiveness of the suggested approach is evaluated compared to traditional concepts of polluted air treatment, ensuring both environmentally friendly and effective production of film coated tablets. Technological changes to improve the impact on the environment have been applied already in many industries as well as in pharmaceutical manufacturing. However, more effort is to be made in order to further decrease particularly VOCs emission into the atmosphere. An analysis is provided to stimulate a proactive approach in this field towards completely eliminating the use of organic solvents from film-coating systems in the production of the pharmaceutical solid dosage forms. The new way of addressing the costs actually associated with embracing cleaner technologies, which are mostly related to regulatory aspects in pharmaceutical industry, is aimed to promote the change in culture, as well as to be applied in the decision making process for other pharmaceutical facilities still using organic solvents based coatings in the manufacturing of tablets. The significance of the small scale projects is additionally emphasized considering the magnitude of the world generic market.
PB  - Elsevier Sci Ltd, Oxford
T2  - Journal of Cleaner Production
T1  - Cleaner production aspects of tablet coating process in pharmaceutical industry: problem of VOCs emission
EP  - 132
SP  - 123
VL  - 44
DO  - 10.1016/j.jclepro.2013.01.004
ER  - 

@article{
author = "Boltić, Zorana and Ružić, Nenad Lj. and Jovanović, Mica and Mihajlović, Marina and Jovanović, Jovan and Petrović, Slobodan",
year = "2013",
abstract = "The aim of the article is to present a case study related to implementation of cleaner production (CP) process with the concept of minimizing emissions versus the end of pipe (EOP) approach within pharmaceutical industry. The idea is to move beyond simple pollution control by technology improvement and prevention of organic solvents emission into the atmosphere. Furthermore, cost-effectiveness of the suggested approach is evaluated compared to traditional concepts of polluted air treatment, ensuring both environmentally friendly and effective production of film coated tablets. Technological changes to improve the impact on the environment have been applied already in many industries as well as in pharmaceutical manufacturing. However, more effort is to be made in order to further decrease particularly VOCs emission into the atmosphere. An analysis is provided to stimulate a proactive approach in this field towards completely eliminating the use of organic solvents from film-coating systems in the production of the pharmaceutical solid dosage forms. The new way of addressing the costs actually associated with embracing cleaner technologies, which are mostly related to regulatory aspects in pharmaceutical industry, is aimed to promote the change in culture, as well as to be applied in the decision making process for other pharmaceutical facilities still using organic solvents based coatings in the manufacturing of tablets. The significance of the small scale projects is additionally emphasized considering the magnitude of the world generic market.",
publisher = "Elsevier Sci Ltd, Oxford",
journal = "Journal of Cleaner Production",
title = "Cleaner production aspects of tablet coating process in pharmaceutical industry: problem of VOCs emission",
pages = "132-123",
volume = "44",
doi = "10.1016/j.jclepro.2013.01.004"
}

Boltić, Z., Ružić, N. Lj., Jovanović, M., Mihajlović, M., Jovanović, J.,& Petrović, S.. (2013). Cleaner production aspects of tablet coating process in pharmaceutical industry: problem of VOCs emission. in Journal of Cleaner Production
Elsevier Sci Ltd, Oxford., 44, 123-132.
https://doi.org/10.1016/j.jclepro.2013.01.004

Boltić Z, Ružić NL, Jovanović M, Mihajlović M, Jovanović J, Petrović S. Cleaner production aspects of tablet coating process in pharmaceutical industry: problem of VOCs emission. in Journal of Cleaner Production. 2013;44:123-132.
doi:10.1016/j.jclepro.2013.01.004 .

Boltić, Zorana, Ružić, Nenad Lj., Jovanović, Mica, Mihajlović, Marina, Jovanović, Jovan, Petrović, Slobodan, "Cleaner production aspects of tablet coating process in pharmaceutical industry: problem of VOCs emission" in Journal of Cleaner Production, 44 (2013):123-132,
https://doi.org/10.1016/j.jclepro.2013.01.004 . .

TY  - JOUR
AU  - Boltić, Zorana
AU  - Ružić, Nenad Lj.
AU  - Jovanović, Mica
AU  - Petrović, Slobodan
PY  - 2010
UR  - http://TechnoRep.tmf.bg.ac.rs/handle/123456789/1721
AB  - This article presents experience from the practice of a successful pharmaceutical company related to design and implementation of performance measures (PMs) for deviation management linked to the analysis of impact on the production cost for the selected product. Case study focuses on PMs within good manufacturing practice (GMP) processes related to quality assurance (QA) and quality management, with the aim of complying with its future requirements proposed by the European Commission. Critical areas were identified based on data gathered from the industrial deviation database. Implementation of the suggested corrective actions showed significant improvement in terms of reducing their number for more than 50% per selected deviation category. The results obtained in the course of this practice-oriented study contribute to further improvement of deviation management in the pharmaceutical industry and performance measurement of other GMP processes. The suggested performance measurement concept and problem-solving techniques may serve both practitioners and the decision-makers within QA and quality control (QC) in order to improve their processes by implementing relevant regulatory requirements for quality management and maintain compliance.
PB  - Springer, New York
T2  - Accreditation and Quality Assurance
T1  - Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study
EP  - 636
IS  - 11
SP  - 629
VL  - 15
DO  - 10.1007/s00769-010-0709-2
ER  - 

@article{
author = "Boltić, Zorana and Ružić, Nenad Lj. and Jovanović, Mica and Petrović, Slobodan",
year = "2010",
abstract = "This article presents experience from the practice of a successful pharmaceutical company related to design and implementation of performance measures (PMs) for deviation management linked to the analysis of impact on the production cost for the selected product. Case study focuses on PMs within good manufacturing practice (GMP) processes related to quality assurance (QA) and quality management, with the aim of complying with its future requirements proposed by the European Commission. Critical areas were identified based on data gathered from the industrial deviation database. Implementation of the suggested corrective actions showed significant improvement in terms of reducing their number for more than 50% per selected deviation category. The results obtained in the course of this practice-oriented study contribute to further improvement of deviation management in the pharmaceutical industry and performance measurement of other GMP processes. The suggested performance measurement concept and problem-solving techniques may serve both practitioners and the decision-makers within QA and quality control (QC) in order to improve their processes by implementing relevant regulatory requirements for quality management and maintain compliance.",
publisher = "Springer, New York",
journal = "Accreditation and Quality Assurance",
title = "Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study",
pages = "636-629",
number = "11",
volume = "15",
doi = "10.1007/s00769-010-0709-2"
}

Boltić, Z., Ružić, N. Lj., Jovanović, M.,& Petrović, S.. (2010). Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study. in Accreditation and Quality Assurance
Springer, New York., 15(11), 629-636.
https://doi.org/10.1007/s00769-010-0709-2

Boltić Z, Ružić NL, Jovanović M, Petrović S. Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study. in Accreditation and Quality Assurance. 2010;15(11):629-636.
doi:10.1007/s00769-010-0709-2 .

Boltić, Zorana, Ružić, Nenad Lj., Jovanović, Mica, Petrović, Slobodan, "Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study" in Accreditation and Quality Assurance, 15, no. 11 (2010):629-636,
https://doi.org/10.1007/s00769-010-0709-2 . .

TY  - JOUR
AU  - Boltić, Zorana
AU  - Petkovska, Menka
AU  - Obradović, Bojana
AU  - Nedović, Viktor
AU  - Bugarski, Branko
PY  - 2003
UR  - http://TechnoRep.tmf.bg.ac.rs/handle/123456789/501
AB  - Results of this study have shown significantly prolonged release of selected antibiotic from liposome dispersion as compared to free antibiotic solution of the same initial concentration. Two models of non-steady one-dimensional diffusion were successfully applied to the experimental data and the antibiotic diffusion coefficients were estimated. In addition, the mass transfer resistance of the membrane was shown to be insignificant confirming the suitability of the applied experimental system. Since liposomes are known as systems with slower drug release, then, when it comes to their incorporation in the final form of a preparation for further experiments in vivo, the system of choice would be liposomes with an encapsulated antibiotic drug. Tfie established experimental system could be extended to other liposome formulations with respect to the release rate of the active components.
PB  - Association of the Chemical Engineers of Serbia
T2  - Chemical Industry & Chemical Engineering Quarterly
T1  - In vitro evaluation of the controlled release of antibiotics from liposomes
T1  - In vitro ispitivanje kontrolisanog otpuštanja antibiotika iz liposoma
EP  - 595
IS  - 4
SP  - 589
VL  - 9
DO  - 10.2298/HEMIND0312589B
ER  - 

@article{
author = "Boltić, Zorana and Petkovska, Menka and Obradović, Bojana and Nedović, Viktor and Bugarski, Branko",
year = "2003",
abstract = "Results of this study have shown significantly prolonged release of selected antibiotic from liposome dispersion as compared to free antibiotic solution of the same initial concentration. Two models of non-steady one-dimensional diffusion were successfully applied to the experimental data and the antibiotic diffusion coefficients were estimated. In addition, the mass transfer resistance of the membrane was shown to be insignificant confirming the suitability of the applied experimental system. Since liposomes are known as systems with slower drug release, then, when it comes to their incorporation in the final form of a preparation for further experiments in vivo, the system of choice would be liposomes with an encapsulated antibiotic drug. Tfie established experimental system could be extended to other liposome formulations with respect to the release rate of the active components.",
publisher = "Association of the Chemical Engineers of Serbia",
journal = "Chemical Industry & Chemical Engineering Quarterly",
title = "In vitro evaluation of the controlled release of antibiotics from liposomes, In vitro ispitivanje kontrolisanog otpuštanja antibiotika iz liposoma",
pages = "595-589",
number = "4",
volume = "9",
doi = "10.2298/HEMIND0312589B"
}

Boltić, Z., Petkovska, M., Obradović, B., Nedović, V.,& Bugarski, B.. (2003). In vitro evaluation of the controlled release of antibiotics from liposomes. in Chemical Industry & Chemical Engineering Quarterly
Association of the Chemical Engineers of Serbia., 9(4), 589-595.
https://doi.org/10.2298/HEMIND0312589B

Boltić Z, Petkovska M, Obradović B, Nedović V, Bugarski B. In vitro evaluation of the controlled release of antibiotics from liposomes. in Chemical Industry & Chemical Engineering Quarterly. 2003;9(4):589-595.
doi:10.2298/HEMIND0312589B .

Boltić, Zorana, Petkovska, Menka, Obradović, Bojana, Nedović, Viktor, Bugarski, Branko, "In vitro evaluation of the controlled release of antibiotics from liposomes" in Chemical Industry & Chemical Engineering Quarterly, 9, no. 4 (2003):589-595,
https://doi.org/10.2298/HEMIND0312589B . .