From experimental design to quality by design in pharmaceutical legislation
Само за регистроване кориснике
2012
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
Quality by design (QbD) is a concept first outlined by Juran, who believed that quality could be planned and that most quality crises and problems relate to the way in which quality was planned in the first place. Experimental design is a powerful technique and tool for QbD, used for exploring new processes, gaining increased knowledge of the existing processes and optimizing these processes for achieving internationally competitive performance. It is also used for the investigation of relationship between parameters of ill-defined process. In this paper, the experimental design principles in pharmaceutical development and impact of these principles on pharmaceutical legislation have been reviewed. Also, slow implementation of QbD in pharmaceutical industries has been discussed. Pharmaceutical legislation is necessary for companies to continue benefiting from knowledge gained and to continually improve throughout the process lifecycle by making adaptations to assure that root causes of... manufacturing problems are quickly corrected.
Кључне речи:
Quality by design / Experimental design / Pharmaceutical quality system / Pharmaceutical legislationИзвор:
Accreditation and Quality Assurance, 2012, 17, 6, 627-633Издавач:
- Springer, New York
Финансирање / пројекти:
- Биљни и синтетички биоактивни производи новије генерације (RS-MESTD-Technological Development (TD or TR)-34012)
DOI: 10.1007/s00769-012-0926-y
ISSN: 0949-1775
WoS: 000311199500008
Scopus: 2-s2.0-84873266851
Институција/група
PharmacyTY - JOUR AU - Savić, Ivan AU - Marinković, Valentina AU - Tasić, Ljiljana AU - Krajnović, Dušanka AU - Savić, Ivana PY - 2012 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1676 AB - Quality by design (QbD) is a concept first outlined by Juran, who believed that quality could be planned and that most quality crises and problems relate to the way in which quality was planned in the first place. Experimental design is a powerful technique and tool for QbD, used for exploring new processes, gaining increased knowledge of the existing processes and optimizing these processes for achieving internationally competitive performance. It is also used for the investigation of relationship between parameters of ill-defined process. In this paper, the experimental design principles in pharmaceutical development and impact of these principles on pharmaceutical legislation have been reviewed. Also, slow implementation of QbD in pharmaceutical industries has been discussed. Pharmaceutical legislation is necessary for companies to continue benefiting from knowledge gained and to continually improve throughout the process lifecycle by making adaptations to assure that root causes of manufacturing problems are quickly corrected. PB - Springer, New York T2 - Accreditation and Quality Assurance T1 - From experimental design to quality by design in pharmaceutical legislation VL - 17 IS - 6 SP - 627 EP - 633 DO - 10.1007/s00769-012-0926-y ER -
@article{ author = "Savić, Ivan and Marinković, Valentina and Tasić, Ljiljana and Krajnović, Dušanka and Savić, Ivana", year = "2012", abstract = "Quality by design (QbD) is a concept first outlined by Juran, who believed that quality could be planned and that most quality crises and problems relate to the way in which quality was planned in the first place. Experimental design is a powerful technique and tool for QbD, used for exploring new processes, gaining increased knowledge of the existing processes and optimizing these processes for achieving internationally competitive performance. It is also used for the investigation of relationship between parameters of ill-defined process. In this paper, the experimental design principles in pharmaceutical development and impact of these principles on pharmaceutical legislation have been reviewed. Also, slow implementation of QbD in pharmaceutical industries has been discussed. Pharmaceutical legislation is necessary for companies to continue benefiting from knowledge gained and to continually improve throughout the process lifecycle by making adaptations to assure that root causes of manufacturing problems are quickly corrected.", publisher = "Springer, New York", journal = "Accreditation and Quality Assurance", title = "From experimental design to quality by design in pharmaceutical legislation", volume = "17", number = "6", pages = "627-633", doi = "10.1007/s00769-012-0926-y" }
Savić, I., Marinković, V., Tasić, L., Krajnović, D.,& Savić, I.. (2012). From experimental design to quality by design in pharmaceutical legislation. in Accreditation and Quality Assurance Springer, New York., 17(6), 627-633. https://doi.org/10.1007/s00769-012-0926-y
Savić I, Marinković V, Tasić L, Krajnović D, Savić I. From experimental design to quality by design in pharmaceutical legislation. in Accreditation and Quality Assurance. 2012;17(6):627-633. doi:10.1007/s00769-012-0926-y .
Savić, Ivan, Marinković, Valentina, Tasić, Ljiljana, Krajnović, Dušanka, Savić, Ivana, "From experimental design to quality by design in pharmaceutical legislation" in Accreditation and Quality Assurance, 17, no. 6 (2012):627-633, https://doi.org/10.1007/s00769-012-0926-y . .