中国食品药品监管Issue(5)：100-109,10.DOI:10.3969/j.issn.1673-5390.2026.05.008
我国药品生产企业清洁验证开展情况问卷调研及结果分析
Cleaning Validation in Chinese Drug Manufacturers:A Questionnaire-Based Survey and Analysis
刘荣 1徐长波 2胡敬峰 1周勇 1曹鸿雁 1韩莹1
作者信息
- 1. 山东省食品药品审评查验中心
- 2. 国家药品监督管理局食品药品审核查验中心
- 折叠
摘要
Abstract
With the advancement of risk management awareness and the application of advanced technologies and facilities in the pharmaceutical industry,the concept of cleaning validation has undergone a fundamental transformation.The introduction of the cleaning validation lifecycle concept marks a shift in industry focus from traditional execution of cleaning validation to the design and development of cleaning processes and ongoing cleaning process verification,integrating cleaning validation into all stages of the drug lifecycle.To better understand the current implementation status of cleaning validation in Chinese drug manufacturers and their level of awareness,this study conducted a questionnaire survey targeting a sample of domestic manufacturers.The findings are expected to provide a theoretical basis for the drafting and revision of relevant technical documents.关键词
清洁验证/全生命周期/药品生产质量管理规范/药品监管Key words
cleaning validation/lifecycle/good manufacturing practice(GMP)/drug regulation分类
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刘荣,徐长波,胡敬峰,周勇,曹鸿雁,韩莹..我国药品生产企业清洁验证开展情况问卷调研及结果分析[J].中国食品药品监管,2026,(5):100-109,10.
