21世纪的清洁验证原料药的清洁接受标准-ispe.pdfVIP

21 世纪的清洁验证：原料药的清洁接受标准 本文讨论了如何从临床和毒理学研究建立真正的以科学为基础的限度，以风险分析为基础的方法来评估清 洁验证数据，从此数据为基础数据设置统计过程控制限额。 Introduction Part I of this article1 discussed the history of Cleaning Validation Acceptance Limits for Active Pharmaceutical Ingredients and where the currently used industry limits came from, analyzed the current approaches to setting acceptance limits, and discussed some of the problems and weaknesses of these approaches. Part II will discuss how to establish true science-based limits using data from clinical and toxicological studies, a risk-based approach to e