Following the launch of its initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," FDA has been looking to process analytical technology (PAT) for improvements in process ...

Department of Cardiothoracic Surgery, New York University Langone Health, New York, NY, United States Objectives: Our goal is to continuously improve patient outcomes, care quality, and overall ...

Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria. Per ICH Q8, the aim of ...

Veeva Systems【NYSE:VEEV】(本社 : カリフォルニア州プレザントン、日本法人 本社 : 東京都渋谷区、日本法人代表取締役 : 岡村 崇、以下 Veeva) は、バイオ医薬品、受託製造、ジェネリック医薬品、医療機器、診断機器などの企業が、グローバル規模での品質 ...

Strictly speaking, if you have a rigorous quality process in place, there should be no reason for a discussion of rework. In fact, it might be said that rework is the result of not having rigorous ...