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.
Keywords:
Quality by design / Experimental design / Pharmaceutical quality system / Pharmaceutical legislation
Source:
Accreditation and Quality Assurance, 2012, 17, 6, 627-633
TY - 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 . .
