XIV International Conference on Industrial Engineering and Environmental Protection – IIZS 2024, str. 279-285
АУТОР / AUTHOR(S): Ilija Tabašević 
, Dragan D. Milanović , Mirjana Misita
DOI: 10.46793/IIZS24.279T
САЖЕТАК / ABSTRACT:
This work is part of the research of the ongoing doctoral dissertation, which aims to integrate nine years of work on projects in the pharmaceutical industry into a scientific research undertaking and to create a cybernetic model for the qualification of pharmaceutical plants. The conclusions of the study presented in this paper aim to unify the responsibilities between the pharmaceutical industry and the contractors, on pharmaceutical plant construction projects. An integrated approach during the qualification of pharmaceutical plants is essential for the success of the entire project because the activities during commissioning and qualification are extremely complex, time-consuming, financially challenging, and affect the start of production activities. This research was conducted using a questionnaire, exclusively for experts in the field of qualifications of pharmaceutical plants. As such, it provides a significant insight into the theoretical and practical guidelines necessary for the precise definition and implementation of an integrated approach and cooperation between contractors and the pharmaceutical industry, taking into account regulatory frameworks and pharmaceutical standards. The defined factors establish the necessary framework for optimizing cooperation and interaction between key actors, pharmaceutical industry employees, and external contractors.
КЉУЧНЕ РЕЧИ / KEYWORDS:
commissioning and qualification, pharmaceutical industry.
ЛИТЕРАТУРА / REFERENCES:
- EudraLex The Rules Governing Medicinal Products in the European Union. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use; EudraLex The Rules Governing Medicinal Products in the European Union: Brussels, Belgium, 2010.
- Baseline Guide: Commissioning & Qualification, 2nd ed.; International Society for Pharmaceutical Engineering: North Bethesda, MD, USA, 2019.
- Andrea Vignoni, Validation life cycle: Commissioning VS Qualification, PQE blog, https://blog.pqegroup.com/commissioning-qualification/validation-life-cycle-commissioning-vs-qualification.
- DeSantis, Phil, and Steven Ostrove. „Commissioning and Qualification.“ Handbook of Validation in Pharmaceutical Processes, Fourth Edition. CRC Press, 2021. 49-65.
- Mali, Mamta R., et al. „A Review on Life Cycle Management Approach on Asset Qualification.“ Journal of Drug Delivery and Therapeutics 10.4 (2020): 253-259.
- Render, Neil, David Greenwood, and Jerry Edge. „The other GMP: good manufacturing practice and its importance in the validation of constructed pharmaceutical facilities.“ Association of Researchers in Construction Management (2005).
- Blackburn, T. D. „A practical approach to commissioning and qualification-a symbiotic relationship.“ Pharmaceutical Engineering 24.4 (2004): 8-19.
- Allan, Wael. „Commissioning and time-to-market.“ Pharmaceutical engineering 24.4 (2004): 60-66.)
- Render, N. The Validation of Pharmaceutical Buildings; University of Northumbria: Newcastle, UK, 2006.
- Tabasevic, I.; Milanovic, D.D. The study of factors affecting the qualification of pharmaceutical facilities. In Proceedings of X International Conference Industrial Engineering and Environmental Protection–IIZS 2020, Zrenjanin, Serbia, 8–9 October 2020; pp. 191–198.
- Tabasevic, I., Milanovic, D. D., Spasojevic Brkic, V., Misita, M., & Zunjic, A. Cybernetic Model Design for the Qualification of Pharmaceutical Facilities. Applied Sciences, 14(13), 5525 (2024).
- Horsley, D.M.C. (Ed.). Process Plant Commissioning: A User Guide; Institute of Chemical Engineers: Warwickshire, UK, ; pp. 165–189 (1998)
- Pai, D.R.; Kamath, K.; Subramanyam, E.V.; Shabaraya, A.R. Personnel training for pharmaceutical industry. Int. J. Pharm. Qual. Assur. 7, 55–61 (2016).