Agalloco J
J Parenter Sci Technol. 1993 May-Jun;47(3):142-7.
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.
验证生命周期是一种实施机制，可协助制药（及其他类型医疗产品）制造商组织和开展验证活动。已有大量工作确定了如何对各种类型和描述的流程进行验证。遗憾的是，关于如何将这些单独的验证活动组织成一个连贯整体的信息却很匮乏。本文介绍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很有帮助的。
