制药企业过程自控系统GMP验证探讨

Discussion about the GMP Validation of Process Automation System in Pharmaceutical Corporation

阐述了制药企业GMP车间的计算机控制系统的验证所涉及的范围,给出了21CFRPart11相关性评估的条件,分析了一种新的V-Model验证模型在验证过程中的应用,并描述了关键验证的详细步骤和具体要求。

This paper introduces the extent relating to the computerized system validation of the GMP plant in pharmaceutical corporation, provides the conditions of the relevant assessment for 21 CFR Part 11, analyses the application of the new validation model named i-V-Modeli- during validation, and describes the detailed process and the specific requirements of the critical validation activities.