生物制品共线生产在当前的生产过程中较为常见，但存在的问题也很多。不同生物制品的生产工艺复杂且各具特点，在共线生产时容易产生交叉污染风险，原辅料种类繁多，其质量控制和残留处理也对共线生产提出了挑战。为指导企业在多品种共线生产时设备清洁验证的开展，本研究从生物制品共线生产面临的种类繁多、工艺复杂、原辅料多样等实际问题出发，通过系统分析生物制品共线生产设备清洁验证的特殊性，如产品质量特性、工艺复杂性、生产设施设备要求、生物安全性要求等方面，以及介绍在生产检查中常见的一些清洁验证方面的缺陷，讨论生物制品共线生产情况下清洁验证的合规性，旨在为企业开展清洁验证提供一定的参考。

 The co-production of biological products is relatively common in the current production process， and there are many existing problems. The production processes of different biological products are complex and each has its own characteristics， which can easily lead to the risk of cross-contamination during collinear production.In order to guide the conducting of equipment Cleaning validation in co-production of multiple varieties， this study starts with the problems faced by the co-production of biological products， and systematically analyzes the particularity of equipment cleaning validation in co-production of biological products， such as product quality characteristics， process complexity， production facilities and equipment requirements， biological safety requirements， etc.，as well as introducing common deficiencies in cleaning validation found in production inspections， and discusses the compliance of cleaning validation in the case of co-production of biological products so as to provide certain references for enterprises to carry out cleaning validation.