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Tasarımla Kalite (Quality By Design: QbD) ve Kalite Risk Yönetimi

Year 2015, Volume: 19 Issue: 1, 12 - 18, 07.01.2015

Buket Aksu

Abstract

Bu derleme kapsamında “Tasarımla Kalite” ve “Kalite
Risk Yönetimi” kavramları açıklanmıştır.
Anahtar Kelimeler: Tasarımla Kalite (QbD), Kalite, Risk Yönetimi, Risk Yönetimi Araçları, 

Keywords

Tasarımla Kalite (QbD) Kalite

References

  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Pharmaceutical Development Q8(R2) (Step 4). (2009). PDF Dokümanı [Erişim Tarihi: 16.12.2014].
  • Cogdill RP. Case for Process Analytical Technology: Regulatory and Industrial Perspectives. In: Pharmaceutical Sciences Encyclopedia: Drug Discovery, Development, and Manufacturing. Ed. Shayne Cox Gad, John Wiley & Sons, New York. 2010, pp. 313-352.
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Quality Risk Management (Q9) (Step 4). (2005). PDF Dokümanı [Erişim Tarihi: 16.12.2014].
  • ISPE. Part 1-Product Realization using QbD, Concepts, and Principles. In: ISPE Guide Series: PQLI from Concept to Continual Improvement. USA. 2011, pp. 1-188.
  • Aksu B. İlaçta Kalite Tasarımı (QbD) ve İlgili Yasal Düzenlemeler, Neta Matbaacılık, İstanbul. 2013.
  • Murray K, Reich S. Quality Risk Management (QRM) Tools Selection: Getting to Right First Time. Engineering Pharmaceutical Innovation. ISPE. USA, 2010.

Year 2015, Volume: 19 Issue: 1, 12 - 18, 07.01.2015

Buket Aksu

Abstract

References

  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Pharmaceutical Development Q8(R2) (Step 4). (2009). PDF Dokümanı [Erişim Tarihi: 16.12.2014].
  • Cogdill RP. Case for Process Analytical Technology: Regulatory and Industrial Perspectives. In: Pharmaceutical Sciences Encyclopedia: Drug Discovery, Development, and Manufacturing. Ed. Shayne Cox Gad, John Wiley & Sons, New York. 2010, pp. 313-352.
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Quality Risk Management (Q9) (Step 4). (2005). PDF Dokümanı [Erişim Tarihi: 16.12.2014].
  • ISPE. Part 1-Product Realization using QbD, Concepts, and Principles. In: ISPE Guide Series: PQLI from Concept to Continual Improvement. USA. 2011, pp. 1-188.
  • Aksu B. İlaçta Kalite Tasarımı (QbD) ve İlgili Yasal Düzenlemeler, Neta Matbaacılık, İstanbul. 2013.
  • Murray K, Reich S. Quality Risk Management (QRM) Tools Selection: Getting to Right First Time. Engineering Pharmaceutical Innovation. ISPE. USA, 2010.
There are 6 citations in total.

Details

Primary Language English
Journal Section Articles
Authors

Buket Aksu

Publication Date January 7, 2015
Published in Issue Year 2015 Volume: 19 Issue: 1

Cite

APA Aksu, B. (2015). Tasarımla Kalite (Quality By Design: QbD) ve Kalite Risk Yönetimi. Marmara Pharmaceutical Journal, 19(1), 12-18. https://doi.org/10.12991/mpj.2015198605
AMA Aksu B. Tasarımla Kalite (Quality By Design: QbD) ve Kalite Risk Yönetimi. Marmara Pharm J. January 2015;19(1):12-18. doi:10.12991/mpj.2015198605
Chicago Aksu, Buket. “Tasarımla Kalite (Quality By Design: QbD) Ve Kalite Risk Yönetimi”. Marmara Pharmaceutical Journal 19, no. 1 (January 2015): 12-18. https://doi.org/10.12991/mpj.2015198605.
EndNote Aksu B (January 1, 2015) Tasarımla Kalite (Quality By Design: QbD) ve Kalite Risk Yönetimi. Marmara Pharmaceutical Journal 19 1 12–18.
IEEE B. Aksu, “Tasarımla Kalite (Quality By Design: QbD) ve Kalite Risk Yönetimi”, Marmara Pharm J, vol. 19, no. 1, pp. 12–18, 2015, doi: 10.12991/mpj.2015198605.
ISNAD Aksu, Buket. “Tasarımla Kalite (Quality By Design: QbD) Ve Kalite Risk Yönetimi”. Marmara Pharmaceutical Journal 19/1 (January 2015), 12-18. https://doi.org/10.12991/mpj.2015198605.
JAMA Aksu B. Tasarımla Kalite (Quality By Design: QbD) ve Kalite Risk Yönetimi. Marmara Pharm J. 2015;19:12–18.
MLA Aksu, Buket. “Tasarımla Kalite (Quality By Design: QbD) Ve Kalite Risk Yönetimi”. Marmara Pharmaceutical Journal, vol. 19, no. 1, 2015, pp. 12-18, doi:10.12991/mpj.2015198605.
Vancouver Aksu B. Tasarımla Kalite (Quality By Design: QbD) ve Kalite Risk Yönetimi. Marmara Pharm J. 2015;19(1):12-8.