An approach to TQM evaluation in pharma business
Samo za registrovane korisnike
2016
Autori
Marinković, Valentina
Bekcić, Stana
Pejović, Gordana B.
Šibalija, Tatjana V.

Majstorović, Vidosav D.

Tasić, Ljiljana

Članak u časopisu (Objavljena verzija)

Metapodaci
Prikaz svih podataka o dokumentuApstrakt
Purpose-The purpose of this paper is to explore the good practice (GxP) and standardised management system integration within total quality management (TQM) paradigm in pharmaceutical sector in Serbia. Also, the impact of all interested parties on quality management has been assessed. Design/methodology/approach-The cross-sectional study was performed, including different stakeholders within the pharmaceutical sector in Serbia: manufacturers, distributors, big pharma representative offices, as well as national regulatory authority. A survey instrument was developed, consisted of 16 questions, which were organised into four groups: questions in relation to implementation of ISO 9001, implementation of good distribution practice/good manufacturing practice, integration of management systems, and impact on TQM and business excellence. Total number of participants was 121. Findings-Standardised management systems (ISO 9001, ISO 14001, OHSAS 18001) support companies to improve business envi...ronment and management sustainability, but this survey indicated that it was ranked at the lower level then GxP, for pharmaceutical sector in Serbia. Although pharmaceutical companies has faced many challenges in recent years, the survey revealed high level of confidence in quality management systems, as well as the necessity of various management systems integration. Originality/value-The perception of TQM by the experts in pharmaceutical companies and regulatory authority is wider than the common TQM definition. From pharmaceutical point of view, TQM is a holistic approach to long-term success of organisation, oriented to all interested parties, with focus on a public health. Risk-based approach in new revision of both ISO and GxP will facilitate integration process towards TQM and business excellence.
Ključne reči:
GxP / Pharmaceutical company / Total quality managementIzvor:
TQM Journal, 2016, 28, 5, 745-759Izdavač:
- Emerald Group Publishing Ltd.
Institucija/grupa
PharmacyTY - JOUR AU - Marinković, Valentina AU - Bekcić, Stana AU - Pejović, Gordana B. AU - Šibalija, Tatjana V. AU - Majstorović, Vidosav D. AU - Tasić, Ljiljana PY - 2016 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2736 AB - Purpose-The purpose of this paper is to explore the good practice (GxP) and standardised management system integration within total quality management (TQM) paradigm in pharmaceutical sector in Serbia. Also, the impact of all interested parties on quality management has been assessed. Design/methodology/approach-The cross-sectional study was performed, including different stakeholders within the pharmaceutical sector in Serbia: manufacturers, distributors, big pharma representative offices, as well as national regulatory authority. A survey instrument was developed, consisted of 16 questions, which were organised into four groups: questions in relation to implementation of ISO 9001, implementation of good distribution practice/good manufacturing practice, integration of management systems, and impact on TQM and business excellence. Total number of participants was 121. Findings-Standardised management systems (ISO 9001, ISO 14001, OHSAS 18001) support companies to improve business environment and management sustainability, but this survey indicated that it was ranked at the lower level then GxP, for pharmaceutical sector in Serbia. Although pharmaceutical companies has faced many challenges in recent years, the survey revealed high level of confidence in quality management systems, as well as the necessity of various management systems integration. Originality/value-The perception of TQM by the experts in pharmaceutical companies and regulatory authority is wider than the common TQM definition. From pharmaceutical point of view, TQM is a holistic approach to long-term success of organisation, oriented to all interested parties, with focus on a public health. Risk-based approach in new revision of both ISO and GxP will facilitate integration process towards TQM and business excellence. PB - Emerald Group Publishing Ltd. T2 - TQM Journal T1 - An approach to TQM evaluation in pharma business VL - 28 IS - 5 SP - 745 EP - 759 DO - 10.1108/TQM-10-2015-0134 ER -
@article{ author = "Marinković, Valentina and Bekcić, Stana and Pejović, Gordana B. and Šibalija, Tatjana V. and Majstorović, Vidosav D. and Tasić, Ljiljana", year = "2016", abstract = "Purpose-The purpose of this paper is to explore the good practice (GxP) and standardised management system integration within total quality management (TQM) paradigm in pharmaceutical sector in Serbia. Also, the impact of all interested parties on quality management has been assessed. Design/methodology/approach-The cross-sectional study was performed, including different stakeholders within the pharmaceutical sector in Serbia: manufacturers, distributors, big pharma representative offices, as well as national regulatory authority. A survey instrument was developed, consisted of 16 questions, which were organised into four groups: questions in relation to implementation of ISO 9001, implementation of good distribution practice/good manufacturing practice, integration of management systems, and impact on TQM and business excellence. Total number of participants was 121. Findings-Standardised management systems (ISO 9001, ISO 14001, OHSAS 18001) support companies to improve business environment and management sustainability, but this survey indicated that it was ranked at the lower level then GxP, for pharmaceutical sector in Serbia. Although pharmaceutical companies has faced many challenges in recent years, the survey revealed high level of confidence in quality management systems, as well as the necessity of various management systems integration. Originality/value-The perception of TQM by the experts in pharmaceutical companies and regulatory authority is wider than the common TQM definition. From pharmaceutical point of view, TQM is a holistic approach to long-term success of organisation, oriented to all interested parties, with focus on a public health. Risk-based approach in new revision of both ISO and GxP will facilitate integration process towards TQM and business excellence.", publisher = "Emerald Group Publishing Ltd.", journal = "TQM Journal", title = "An approach to TQM evaluation in pharma business", volume = "28", number = "5", pages = "745-759", doi = "10.1108/TQM-10-2015-0134" }
Marinković, V., Bekcić, S., Pejović, G. B., Šibalija, T. V., Majstorović, V. D.,& Tasić, L.. (2016). An approach to TQM evaluation in pharma business. in TQM Journal Emerald Group Publishing Ltd.., 28(5), 745-759. https://doi.org/10.1108/TQM-10-2015-0134
Marinković V, Bekcić S, Pejović GB, Šibalija TV, Majstorović VD, Tasić L. An approach to TQM evaluation in pharma business. in TQM Journal. 2016;28(5):745-759. doi:10.1108/TQM-10-2015-0134 .
Marinković, Valentina, Bekcić, Stana, Pejović, Gordana B., Šibalija, Tatjana V., Majstorović, Vidosav D., Tasić, Ljiljana, "An approach to TQM evaluation in pharma business" in TQM Journal, 28, no. 5 (2016):745-759, https://doi.org/10.1108/TQM-10-2015-0134 . .