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摘要

验证生命周期是一种实施机制,可以帮助药品(和其他类型的医疗产品)制造商组织和执行验证活动。存在大量的工作来确定如何验证各种类型和描述的过程。不幸的是,缺乏关于如何将这些单独的验证活动组织成一个内聚整体的信息。本文描述了一种以合理有效的方式实现组织验证目标的建议方法。为了更好地理解验证生命周期的优势,回顾一下美国制药行业的验证历史是有用的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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The validation life cycle.

The Validation Life Cycle is an implementation mechanism which can assist pharmaceutical (and other types of medical product) manufacturers in the organization and execution of validation activities. A considerable body of work exists which identifies how to validate processes of various type and description. Unfortunately, there is a paucity of information on how to organize these individual validation activities into a cohesive whole. This paper describes a suggested means for achieving an organization's validation goals in a rational and effective fashion. To best understand the advantages of a life cycle for validation, a recap of the history of validation in the U.S. pharmaceutical industry is useful.

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Evaluating out-of-specification laboratory results. Simplifying and improving process validation. Depyrogenation of pharmaceutical solutions using submicron and ultrafilters. USP perspectives on particle contamination of injectable products. Moisture measurement: a new method for monitoring freeze-drying cycles.
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