مناهج التصميم بالجودة في تطوير الأدوية وإنتاج الأشكال الصيدلانية الصلبة: نظرة عامة سردية
DOI:
https://doi.org/10.35516/jjps.v16i4.908الكلمات المفتاحية:
التصميم بالجودة، تطوير الأدوية، الأشكال الصيدلانية الصلبة، تصنيع الأدوية، النهج القائم على المخاطرالملخص
التصميم بالجودة (QbD) هو نهج أساسي في تطوير الأدوية وتصنيعها، وقد حظي باهتمام كبير في السنوات الأخيرة. الجودة في الخدمات والمنتجات والإجراءات تعني رضا العملاء. نتيجة لذلك، فهي تسهل الانتقال في القطاع الصيدلاني وإدارة الغذاء والدواء (FDA) نحو استراتيجية تطوير الأدوية التي تكون أكثر علمية، قائمة على المخاطر، شاملة، واستباقية. تسعى الصناعة الصيدلانية إلى حلول جديدة لضمان جودة المنتج وكفاءته. يقدم هذا البحث نظرة عامة شاملة على مبادئ QbD وتطبيقاتها في الصناعة الصيدلانية. يتم مناقشة فوائد تطبيق مبادئ QbD، بما في ذلك زيادة الكفاءة، وتقليل التكاليف، وتحسين جودة المنتج، والسلامة، والفعالية. مع استمرار تطور الصناعة الصيدلانية، سيظل QbD جانبًا أساسيًا في تطوير الأدوية وتصنيعها، ويهدف هذا المقال إلى توفير فهم شامل لمنهج QbD للعاملين في مجال الصيدلة.
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