Farmasötik Ürünlerde Tasarımla Kalite Yaklaşımı

Year 2013, Issue: 2, 203 - 230, 01.06.2013

Fidan Mike Sibel Bozdağ Pehlivan Levent Öner

Abstract

Tasarımla Kalite; önceden belirlenmiş amaçlarla başlayan, güvenilir bilimsel veriler ve kalite risk yönetiminin temel alındığı, ürün ve üretim işleminin iyi bir şekilde anlaşılmasının önemini vurgulayan sistematik bir farmasötik ürün geliştirme yaklaşımıdır. Bu modern yaklaşım, kalite hedef ürün profilinin tanımlanması, kritik kalite özellikleri ve kritik işlem parametrelerinin belirlenmesi, tasarım aralığı ve kontrol stratejisi oluşturulması gibi öğelerden oluşmaktadır. Tasarımla kalite uygulamalarında proses analitik teknolojisi araçlarının ve gerçek zamanlı serbest bırakma stratejilerinin kullanımı ilaç üretim süreçlerinin etkinliğini arttırmaktadır. Tasarımla kalite yaklaşımında farmasötik ürün kalitesi, formülasyon ve üretim işlemi değişkenlerinin anlaşılması ve kontrol edilmesi ile güvence altına alınmaktadır.

Keywords

Tasarımla kalite, kritik kalite özellikleri, kritik işlem parametreleri, tasarım aralığı, kontrol stratejisi

Quality by Design in Pharmaceuticals

Abstract

Pharmaceutical Quality by Design is a systematic approach to pharmaceutical development which begins with predefined objectives and emphases product and processes understanding. Elements of this modern approach include; defining quality target product profile, identifying critical quality attributes and critical process parameters, establishing design space, and developing control strategy. Use of process analytical technology and real time release strategies in quality by design enhances efficiency of pharmaceutical manufacturing. Pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables in quality by design approach.

Keywords

Quality by design, critical quality attributes, critical process parameters, design space, control strategy

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