Farmasötiklerde yeni kalite kavramları

Büyük hızla yeniliklere adapte olmaya çalışan ilaç sanayii, son yıllarda, üretim bilgilerinde, kalite yönetim sistemlerinde ve risk yönetiminde önemli ilerlemeler yaşamış ve üretim kalitesinin sağlanmasına yardımcı olmak için kullanılabilecek modern üretim araçları geliştirmiştir. Bu yeni araçlar üreticilerin problemleri saptamasına, analiz etmesine, düzeltmesine, önlemesine ve üretim süreçlerini sürekli olarak iyileştirmesine yardım etmektedir. Bu gelişmeler üzerine, 2002 yılında Amerikan Gıda ve İlaç Dairesi (FDA), ilaç üretimini düzenleyen kuralları ve ürün kalitesini daha da geliştirmek ve modernize etmek amacı ile Güncel İyi Üretim Uygulamalarındaki (cGMP) yenilikleri ilaç endüstrisine duyurmuştur. ABD, Japonya ve Avrupa’da ilaç endüstrisinin yetkilileri ve uzmanlardan oluşan, ilaç ürünleri için teknik gereksinimlerin bu üç bölgede uyumlaştırılması amacıyla kurulmuş bir forum olan Uluslararası Harmonizasyon Kurumu (ICH), endüstriye Tasarımla Kalite (QbD) olarak adlandırılan yeni bir yaklaşım getirmek için güncel kılavuzları (ICH Q8, Q9, Q10 ve Q11) yayınlamıştır. Kaliteyi test etmek yerine tasarımla sağlayan bu yeni yaklaşımın bir sonucu olarak, üründe kalite artışı, üretim maliyetinde azalma ve ürünün piyasaya daha kısa sürede sunulması sağlanmaktadır. Ayrıca, hastanın güvenliği ve daha kaliteli ilaca daha kısa sürede ulaşması üzerinde durulmaktadır.

Anahtar Kelimeler:

Üretim Kalitesi, ICH, Tasarımla kalite

New quality concepts in pharmaceuticals

During the recent years, the pharmaceutical industry, trying to adapt itself to innovations by leaps and bounds, has experienced major developments in production information, quality management systems and risk management, and has developed modern production tools that can assist in ensuring the production quality. These new tools help the manufacturers identify, analyze, correct and prevent problems, and constantly enhance the production processes. Therefore, in 2002, the Food and Drug Administration (FDA) introduced to the drug pharmaceutical industry the amendments in the current Good Manufacturing Practices (cGMP) to improve and modernize the rules that regulate the pharmaceutical product manufacturing and the pharmaceutical product quality. International Conference on Harmonization (ICH) is a forum that gathers the authorities and experts of the pharmaceutical industry in the USA, Japan and Europe to harmonize the technical requirements for pharmaceutical products in these three regions, published current guidelines (ICH Q8, Q9, Q10 and Q11) to bring a new approach which called Quality by Design (QbD) to the industry. As a result of using the new approach of providing quality by design rather than testing it, quality increase, cost reduction and faster market access have been achieved in manufactured products. Moreover, patient safety is emphasized and quicker access to pharmaceutical products by the patient is ensured with a higher quality products.

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