Kısa Rapor
Yıl 2021,
Cilt: 3 Sayı: 1, 45 - 50, 31.01.2021
Öz
Kaynakça
- Aksu N. B. (2013). İlaçta Kalite Tasarımı (QbD) ve İlgili Yasal düzenlemeler [Pharmaceutical Quality by Design and regulations] 1st Ed.,Santa Farma, Istanbul, Turkey. ISBN: 978-605-125-950-5.
- Cogdill, R. (2008). Case for Process Analytical Technology: Regulatory and Industrial Perspectives. 1st Ed., In Gad S. (Eds.), Pharmaceutical Sciences Encyclopedia: Drug Discovery, Development, and Manufacturing (pp. 313–352). John Wiley & Sons, New York, USA. https://doi.org/10.1002/9780470571224.pse383
- International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. (2009). ICH Q8 (R2) - ICH Harmonized Tripartite Guideline, Pharmaceutical Development. https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf
- Kessler, R. W., Kessler, W. (2020). Best Practice and Performance of Hardware in Process Analytical Technology (PAT). 2nd Ed., In Brown S., Tauler R., Walczak B. (Eds.), Comprehensive Chemometrics, Volume 4 (pp. 237-274). Elsevier. https://doi.org/10.1016/B978-0-12-409547-2.14611-6
- Kumari, S. (2020). Barrier Analysis for the Implementation of Pharma 4.0 Techniques in Logistics and Transportation of Pharmaceutical Products-An Ism Approach. Psychology and Education, 58(9), 5677-5685. https://doi.org/10.17762/pae.v57i9.2491
- Mészáros, L. et al. (2020). Digital UV/VIS imaging: A rapid PAT tool for crushing strength, drug content and particle size distribution determination in tablets. International Journal of Pharmaceutics, 578, 119174. https://doi.org/10.1016/j.ijpharm.2020.119174
- Reinhardt, I. C., Oliveira J. C., Ring, D. T. (2020). Current Perspectives on the Development of Industry 4.0 in the Pharmaceutical Sector. Journal of Industrial Information Integration, 18, 100131. https://doi.org/10.1016/j.jii.2020.100131
- Reinhardt, I. C., Oliveira J. C., Ring, D. T. (2021, April 28). Industry 4.0 & the Future of the Pharmaceutical Industry. https://ispe.org/pharmaceutical-engineering/march-april-2021/industry-40-future-pharmaceutical-industry?TOKEN=B4D81549-4283-4167-8B5F-7AC4DDCBF62E#footnote5_z8s2tck
- Shah, R., Brorson K., Read E., Park J., Watts C., Khan M. (2011). Scientific and Regulatory Overview of Process Analytical Technology in Bioprocesses. 1st Ed., In Undey C., Low D., Menezes J.C., Koch M. (Eds.), PAT Applied in Biopharmaceutical Process Development And Manufacturing (pp. 1-8). CRC Press, Taylor&Francis, Boca Raton, FL, USA. https://doi.org/10.1201/b11536
- Stagner, W. C., Haware, R. V. (2019). QbD Innovation Through Advances in PAT, Data Analysis Methodologies, and Material Characterization. AAPS PharmSciTech, 20(295), 2. https://doi.org/10.1208/s12249-019-1506-9
- Vaidya, S., Ambad, P., Bhosle, S. (2018). Industry 4.0–a glimpse. Procedia Manufacturing, 20, 233- 238. https://doi.org/10.1016/j.promfg.2018.02.034
- Wu, H., Khan, M. A. (2010). Quality-by-Design (QbD): An Integrated Process Analytical Technology (PAT) Approach for Real-Time Monitoring and Mapping the State of a Pharmaceutical Coprecipitation Process. Journal of Pharmaceutical Sciences, 99(3), 1516 – 1534. https://doi.org/10.1002/jps.21923
- Wu, H., White, M., Khan, M. A. (2011). Quality-by-Design (QbD): An integrated process analytical technology (PAT) approach for a dynamic pharmaceutical co-precipitation process characterization and process design space development. International Journal of Pharmaceutics, 405(1-2), 63–78. https://doi.org/10.1016/j.ijpharm.2010.11.045
Yıl 2021,
Cilt: 3 Sayı: 1, 45 - 50, 31.01.2021
Öz
The innovations of the Industry 4.0 revolution in the New World aimed at creating a society where we can solve many problems in every sector and social life. As a condition for Industry 4.0, industrial sectors are heading towards digitalization and automation. Pharmaceutical Industry takes its share in this sense and tries to keep up with this pace in the context of Pharma 4.0 which is a hot topic. However, it is a known fact that developing safe and effective new treatments is a long, difficult and expensive process, so FDA released the Pharmaceutical cGMPs for the 21st-century report and in this report; it specified Quality by Design (QbD) and Process Analytical Technologies (PAT) initiative to bring a solution. The introduction of the new QbD approach, which advocates providing the quality within the product with design instead of testing, brought an increase in the quality of the products manufactured, a decrease in costs and accelerated the market launch of the medicines. Moreover, patient safety is brought to the fore with better quality medicines and the patient accesses the drug in a shorter time.
Anahtar Kelimeler
Industry 4.0 pharma 4.0 QbD PAT pharmaceutical development pharmaceutical manufacture
Kaynakça
- Aksu N. B. (2013). İlaçta Kalite Tasarımı (QbD) ve İlgili Yasal düzenlemeler [Pharmaceutical Quality by Design and regulations] 1st Ed.,Santa Farma, Istanbul, Turkey. ISBN: 978-605-125-950-5.
- Cogdill, R. (2008). Case for Process Analytical Technology: Regulatory and Industrial Perspectives. 1st Ed., In Gad S. (Eds.), Pharmaceutical Sciences Encyclopedia: Drug Discovery, Development, and Manufacturing (pp. 313–352). John Wiley & Sons, New York, USA. https://doi.org/10.1002/9780470571224.pse383
- International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. (2009). ICH Q8 (R2) - ICH Harmonized Tripartite Guideline, Pharmaceutical Development. https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf
- Kessler, R. W., Kessler, W. (2020). Best Practice and Performance of Hardware in Process Analytical Technology (PAT). 2nd Ed., In Brown S., Tauler R., Walczak B. (Eds.), Comprehensive Chemometrics, Volume 4 (pp. 237-274). Elsevier. https://doi.org/10.1016/B978-0-12-409547-2.14611-6
- Kumari, S. (2020). Barrier Analysis for the Implementation of Pharma 4.0 Techniques in Logistics and Transportation of Pharmaceutical Products-An Ism Approach. Psychology and Education, 58(9), 5677-5685. https://doi.org/10.17762/pae.v57i9.2491
- Mészáros, L. et al. (2020). Digital UV/VIS imaging: A rapid PAT tool for crushing strength, drug content and particle size distribution determination in tablets. International Journal of Pharmaceutics, 578, 119174. https://doi.org/10.1016/j.ijpharm.2020.119174
- Reinhardt, I. C., Oliveira J. C., Ring, D. T. (2020). Current Perspectives on the Development of Industry 4.0 in the Pharmaceutical Sector. Journal of Industrial Information Integration, 18, 100131. https://doi.org/10.1016/j.jii.2020.100131
- Reinhardt, I. C., Oliveira J. C., Ring, D. T. (2021, April 28). Industry 4.0 & the Future of the Pharmaceutical Industry. https://ispe.org/pharmaceutical-engineering/march-april-2021/industry-40-future-pharmaceutical-industry?TOKEN=B4D81549-4283-4167-8B5F-7AC4DDCBF62E#footnote5_z8s2tck
- Shah, R., Brorson K., Read E., Park J., Watts C., Khan M. (2011). Scientific and Regulatory Overview of Process Analytical Technology in Bioprocesses. 1st Ed., In Undey C., Low D., Menezes J.C., Koch M. (Eds.), PAT Applied in Biopharmaceutical Process Development And Manufacturing (pp. 1-8). CRC Press, Taylor&Francis, Boca Raton, FL, USA. https://doi.org/10.1201/b11536
- Stagner, W. C., Haware, R. V. (2019). QbD Innovation Through Advances in PAT, Data Analysis Methodologies, and Material Characterization. AAPS PharmSciTech, 20(295), 2. https://doi.org/10.1208/s12249-019-1506-9
- Vaidya, S., Ambad, P., Bhosle, S. (2018). Industry 4.0–a glimpse. Procedia Manufacturing, 20, 233- 238. https://doi.org/10.1016/j.promfg.2018.02.034
- Wu, H., Khan, M. A. (2010). Quality-by-Design (QbD): An Integrated Process Analytical Technology (PAT) Approach for Real-Time Monitoring and Mapping the State of a Pharmaceutical Coprecipitation Process. Journal of Pharmaceutical Sciences, 99(3), 1516 – 1534. https://doi.org/10.1002/jps.21923
- Wu, H., White, M., Khan, M. A. (2011). Quality-by-Design (QbD): An integrated process analytical technology (PAT) approach for a dynamic pharmaceutical co-precipitation process characterization and process design space development. International Journal of Pharmaceutics, 405(1-2), 63–78. https://doi.org/10.1016/j.ijpharm.2010.11.045
Toplam 13 adet kaynakça vardır.
Ayrıntılar
| Birincil Dil | İngilizce |
|---|---|
| Konular | Sağlık Kurumları Yönetimi |
| Bölüm | Review |
| Yazarlar | |
| Yayımlanma Tarihi | 31 Ocak 2021 |
| Kabul Tarihi | 26 Mayıs 2021 |
| Yayımlandığı Sayı | Yıl 2021 Cilt: 3 Sayı: 1 |
