TY  - JOUR
AU  - Bekcić, Stana
AU  - Kelecević, Nenad
AU  - Marinković, Valentina
AU  - Tasić, Ljiljana
AU  - Krajnović, Dušanka
PY  - 2015
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2437
AB  - Outsourcing is increasingly used by the vaccine manufacturers. When the manufacturing activities are outsourced, the contract manufacturer's Good Manufacturing Practice compliance needs to be confirmed through auditing. In the same way, when distribution is outsourced, the contract distributor's Good Distribution Practice compliance needs to be confirmed through auditing. The objective of this study was to develop an audit preparation tool for the pharmaceutical contract vaccine distributor and to validate its contents by using the Delphi method. Based on this, a tool was developed for the contract vaccine distributors. The Delphi method was used with a group of 14 experts from the pharmaceutical industry, authorities and university. The response rate in the Delphi questionnaire round was 100 %. The tool consisted of 33 quality items, out of which 29 (88%) achieved the pre-defined agreement rate level (>75%). The four quality items which did not achieve the pre-defined agreement rate were excluded from the tool. The expert group suggested only minor changes to the tool. The results show that the content validity of the developed audit preparation tool was good. The resultant questionnaire is ready to use. Developed the ready-to-use questionnaire based on critical factors evaluation, gives an objective picture of the possibilities of the potential partner and help organisations make quality decision on the selection of contract vaccine distributors. The contract vaccine distributor must be permanently controlled and analysed, so as to maintain the required quality and to keep low level of costs.
PB  - Assoc Pharmaceutical Teachers India, Bangalore
T2  - Indian Journal of Pharmaceutical Education and Research
T1  - Developing a quality management tool for preparing Good Distribution Practice audit of pharmaceutical contract vaccine distributor
VL  - 49
IS  - 3
SP  - 174
EP  - 182
DO  - 10.5530/ijper.49.3.2
ER  - 

@article{
author = "Bekcić, Stana and Kelecević, Nenad and Marinković, Valentina and Tasić, Ljiljana and Krajnović, Dušanka",
year = "2015",
abstract = "Outsourcing is increasingly used by the vaccine manufacturers. When the manufacturing activities are outsourced, the contract manufacturer's Good Manufacturing Practice compliance needs to be confirmed through auditing. In the same way, when distribution is outsourced, the contract distributor's Good Distribution Practice compliance needs to be confirmed through auditing. The objective of this study was to develop an audit preparation tool for the pharmaceutical contract vaccine distributor and to validate its contents by using the Delphi method. Based on this, a tool was developed for the contract vaccine distributors. The Delphi method was used with a group of 14 experts from the pharmaceutical industry, authorities and university. The response rate in the Delphi questionnaire round was 100 %. The tool consisted of 33 quality items, out of which 29 (88%) achieved the pre-defined agreement rate level (>75%). The four quality items which did not achieve the pre-defined agreement rate were excluded from the tool. The expert group suggested only minor changes to the tool. The results show that the content validity of the developed audit preparation tool was good. The resultant questionnaire is ready to use. Developed the ready-to-use questionnaire based on critical factors evaluation, gives an objective picture of the possibilities of the potential partner and help organisations make quality decision on the selection of contract vaccine distributors. The contract vaccine distributor must be permanently controlled and analysed, so as to maintain the required quality and to keep low level of costs.",
publisher = "Assoc Pharmaceutical Teachers India, Bangalore",
journal = "Indian Journal of Pharmaceutical Education and Research",
title = "Developing a quality management tool for preparing Good Distribution Practice audit of pharmaceutical contract vaccine distributor",
volume = "49",
number = "3",
pages = "174-182",
doi = "10.5530/ijper.49.3.2"
}

Bekcić, S., Kelecević, N., Marinković, V., Tasić, L.,& Krajnović, D.. (2015). Developing a quality management tool for preparing Good Distribution Practice audit of pharmaceutical contract vaccine distributor. in Indian Journal of Pharmaceutical Education and Research
Assoc Pharmaceutical Teachers India, Bangalore., 49(3), 174-182.
https://doi.org/10.5530/ijper.49.3.2

Bekcić S, Kelecević N, Marinković V, Tasić L, Krajnović D. Developing a quality management tool for preparing Good Distribution Practice audit of pharmaceutical contract vaccine distributor. in Indian Journal of Pharmaceutical Education and Research. 2015;49(3):174-182.
doi:10.5530/ijper.49.3.2 .

Bekcić, Stana, Kelecević, Nenad, Marinković, Valentina, Tasić, Ljiljana, Krajnović, Dušanka, "Developing a quality management tool for preparing Good Distribution Practice audit of pharmaceutical contract vaccine distributor" in Indian Journal of Pharmaceutical Education and Research, 49, no. 3 (2015):174-182,
https://doi.org/10.5530/ijper.49.3.2 . .

TY  - JOUR
AU  - Bekcić, Stana
AU  - Kelecević, Nenad
AU  - Marinković, Valentina
AU  - Tasić, Ljiljana
AU  - Krajnović, Dušanka
PY  - 2013
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1891
AB  - This paper discusses how a system approach to management can be used for the development and implementation of an integrated management system (IMS) in a company producing medicinal products. It is argued in the paper that approaches to the solutions of how to integrate management systems all require two elements: a conceptual model and a supporting methodology. Although a large number of models has been developed that could provide the basis for integration, development of methodologies to achieve fully integrated systems is still stagnating. This paper presents the IMS model that can be used to integrate the requirements of existing and upcoming standards in the pharmaceutical industry, followed by a discussion on the issue of the IMS methodology.
PB  - Assoc Pharmaceutical Teachers India, Bangalore
T2  - Indian Journal of Pharmaceutical Education and Research
T1  - Approach to the Integration of Management Systems in a Pharmaceutical Organization
VL  - 47
IS  - 3
SP  - 19
EP  - 25
DO  - 10.5530/ijper.47.3.4
ER  - 

@article{
author = "Bekcić, Stana and Kelecević, Nenad and Marinković, Valentina and Tasić, Ljiljana and Krajnović, Dušanka",
year = "2013",
abstract = "This paper discusses how a system approach to management can be used for the development and implementation of an integrated management system (IMS) in a company producing medicinal products. It is argued in the paper that approaches to the solutions of how to integrate management systems all require two elements: a conceptual model and a supporting methodology. Although a large number of models has been developed that could provide the basis for integration, development of methodologies to achieve fully integrated systems is still stagnating. This paper presents the IMS model that can be used to integrate the requirements of existing and upcoming standards in the pharmaceutical industry, followed by a discussion on the issue of the IMS methodology.",
publisher = "Assoc Pharmaceutical Teachers India, Bangalore",
journal = "Indian Journal of Pharmaceutical Education and Research",
title = "Approach to the Integration of Management Systems in a Pharmaceutical Organization",
volume = "47",
number = "3",
pages = "19-25",
doi = "10.5530/ijper.47.3.4"
}

Bekcić, S., Kelecević, N., Marinković, V., Tasić, L.,& Krajnović, D.. (2013). Approach to the Integration of Management Systems in a Pharmaceutical Organization. in Indian Journal of Pharmaceutical Education and Research
Assoc Pharmaceutical Teachers India, Bangalore., 47(3), 19-25.
https://doi.org/10.5530/ijper.47.3.4

Bekcić S, Kelecević N, Marinković V, Tasić L, Krajnović D. Approach to the Integration of Management Systems in a Pharmaceutical Organization. in Indian Journal of Pharmaceutical Education and Research. 2013;47(3):19-25.
doi:10.5530/ijper.47.3.4 .

Bekcić, Stana, Kelecević, Nenad, Marinković, Valentina, Tasić, Ljiljana, Krajnović, Dušanka, "Approach to the Integration of Management Systems in a Pharmaceutical Organization" in Indian Journal of Pharmaceutical Education and Research, 47, no. 3 (2013):19-25,
https://doi.org/10.5530/ijper.47.3.4 . .