کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5550303 1557287 2017 6 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
The future of pharmaceutical quality and the path to get there
ترجمه فارسی عنوان
آینده کیفیت دارویی و مسیری برای رسیدن به آنجا
کلمات کلیدی
کیفیت دارویی، شش سیگما، کیفیت توسط طراحی، مقررات مبتنی بر عملکرد، تولید دارویی پیشرفته، ظرفیت پردازش،
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی علوم دارویی
چکیده انگلیسی

While six sigma quality has long been achieved in other industries, it is rarely seen in the pharmaceutical sector. However, consumers and patients deserve six sigma quality pharmaceuticals with minimal risks of shortages or recalls. We propose that the future of pharmaceutical quality is six sigma, meaning that no more than 3.4 defects occur per million opportunities. We discuss the path to get there, including economic drivers, performance-based regulation, Quality by Design, advanced manufacturing technologies, and continuous improvement and operational excellence. This article outlines an ambitious goal and is intended to be thought-provoking in spite of the challenging path to get there. This goal is envisioned because it is in the best interest of patients and consumers and is realizable with continued advances and investments in science and technology. The fundamental destination of pharmaceutical quality has been long envisioned: a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: International Journal of Pharmaceutics - Volume 528, Issues 1–2, 7 August 2017, Pages 354-359
نویسندگان
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