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