关于淋洗法验证.pdf

STERIS Rinse sampling for Cleaning Validation Studies 清洁验证中淋洗取样法的研究 Destin A. Le Blanc Rinse-sampling procedures that draw from the final rinse solution can provide upper-limit estimates of potential contamination in subsequently manufactured products. The process can be improved by separating the process rinse from the sampling rinse. This may result in more accurate actual estimates, more flexibility in selecting analytical procedures, and more flexibility in choosing a sampling rinse solution that is different from the process rinse solution. Procedures for such determinations depend on adequate rinse recovery studies. This article describes these studies. 从最终淋洗溶液取样的淋洗液取样程序可以提供后续生产产品中潜在污染物的上限评估。该程序中也可将 淋洗工艺和取样工艺分开。选择不同的更加灵活分析规程、选择与淋洗工艺不同的取样淋洗溶剂，均可以 得到更准确的结果评估。这些检测程序均基于充分的淋洗回收率研究。本文即描述这些研究 Validation of cleaning processes used for product contact surfaces in pharmaceutical manufacturing is required by FDA. The 1993 decision of US v. Barr Laboratories gave FDA the right to mandate that cleaning is a critical process that must be validated (1). Although this decision focused mainly on issues related to retesting after out-of-specification results, it also held that FDA had the right in this case to mandate validation of cleaning processes. In July 1992, while this case was being litigated, the agency’s Mid-Atlantic Region staff developed an internal inspection guideline for cleaning validation (2). In July 1993, the more official and still current “Guide to Inspections of Validation of Cleaning Processes” was issued (3) FDA 要求药品生产中对于产品直接接触的表面清洁工艺必须进行验证。1993 年美国 Barr Laboratories 案例 （注1）的判决结果中赋予了FDA 将清洁规定为关键工艺且必须经 过验证的权利。尽管这次决议主要关注的是 OOS 后的复测相关问题，但仍可认为 FDA 在 这次案例中获得了清洁工艺验证的授权。1992 年7 月，这场官司还在诉讼期时，中大西洋 地区部门开发了清洁验证内部检查指南 （注2 ）。1993 年7 月，更官方的并且现在仍通行的 《清洁验证检查指南》发布了 （注3）。 The 1992 Mid-Atlanti