Louis W. Yu, Ph.D. (Perrigo Senior Vice President, Global Quality & Compliance)所讲到的“Right First Time Culture”是我一直未注意到。科研就是试错,我们追求的不是这种文化,但工业界,尤其在仿制药和通用名药物领域,质量是第一竞争力,如何进行产品风险控制,那么围绕着这个主题,Right First Time Culture就是必不可少的。
Risk Mitigation Require Right First Time Culture • Pharmaceutical manufacturing remain predominantly manual, batchprocesses • Opportunities for error exist in each part of the unit operations from dispensing to packaging • Pharmaceutical manufacturing quality level typically below 4 sigma • Current regulatory approach discourages changes and adoption of new error proofing technology