制药设备自动化系统验证方法

摘要

以无菌配液系统的自动化系统为实例，介绍了制药设备的自动化系统如何根据GAMP5的基本概念进行实际的自动化系统验证。并根据验证V型模型，介绍了系统从开发到应用过程的实际情况，以及“规范”与“验证”方面的内容。%Exampled with the automatic control system in sterile formulation system, the actual process of automation system validation based on fundamental concept of GAMP5 was introduced in this article. And with the validation of V model, the actual procedures from development to application for the system were introduced, emphatically in the aspects of the content in codes and in validation.