According to Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at FDA, quality is “defined as a product that reliably delivers the therapeutic benefit promised on the label to the patient and is free of contamination.”
Every day, people are taking medication and without even realizing it, they’re making assumptions about the quality of the product. Patients assume their drugs are efficacious, that they have the correct identity, that they’ll receive the same drug performance as described on the label, that they are made in a manner that ensures quality and that they will be available when needed. But, in reality, two-thirds of drug shortages are due to quality issues and drug product recalls are increasing.
进入药品质量（OPQ）办公室，一个单位的CDER。OPQ的优先事项是建立一种与制造商建立协作方法，以鼓励创新和采用新技术。Michael Kocha博士，博士，博士，CDER，FDA办公室，CDER，FDA办公室董事，介绍了遵守华盛顿特区PDA / FDA联合监管会议的遵守质量的透视。
凭借前所未有的全球化供应链，精密药物和生物仿制物的新时代，以及科学景观的重大进步，现有的监管范例正在经历压力。
OPQ旨在建立一致，临床相关的质量标准和对工业的明确期望，同时强调跨设施监测质量指标和监测技术，并鼓励使用现代，更高效的制造技术。
The desired state of the OPQ is much more proactive than the previous compliance-based approach. Where the OPQ was reactive to deviations, they now want to anticipate issues. Where they were secretive, they now wish to be transparent. Where they supported static manufacturing processes, they now seek to foster continuous improvement. Where there have been data gaps, they now want to be far more data-driven.
产品召回和毒品短缺的主要原因之一是在旧平台上制造新产品。OPQ希望鼓励制造商采用新兴技术来应对质量问题。采用新技术将允许其他事情，更少的中断，更少的产品失败，以及更大的临床表现保证。
FDA has established the Emerging Technology Team (ETT). This cross-functional team is designed to help manufacturers implement a variety of technological advancements while ensuring consistency and continuity. In addition, the members play an active or leadership role in the OPQ quality assessment team for applications containing an emerging technology. The ETT has actively been working on topics such as continuous manufacturing, 3D printing of drug products and new container/closure systems. In addition, they’ve launched an initiative encouraging engineers at generic manufacturers to adopt emerging technologies, even offering to help and consider solutions for reducing costs.
最终，OPQ希望增加透明度和数据监测将允许他们识别“良好”和“糟糕的”玩家以及OPC需要花费时间的组织。它相信生产优质产品的优质公司应得到奖励。
Kocha博士被问及那些“奖励”，他表明他们仍在努力弄清楚奖励看起来像较少的监督，但时间表，指标等尚未建立。他指出，在查看PDA / FDA会议与会者名单时，许多高质量的制造商都出席了，说：“就像真正的罪人是那些不上教堂的人。”
