CHINESE JOURNAL OF MEDICINAL GUIDE >

2026 , Vol. 28 >Issue 4: 493 - 493-496

DOI: https://doi.org/10.1009-0959.2025.120006

Specialty and Common Issues of Cleaning Validation for Biological Products Co-production

  • 荣 刘
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  • 1.Shandong Center for Food and Drug Evaluation & Inspection， Shandong Jinan 250014， China；
    2.Center for Food and Drug Inspection of NMPA， Beijing 100076， China

Received date: 2025-06-09

  Revised date: 2025-09-05

  Accepted date: 2026-05-26

  Online published: 2026-05-26

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Abstract

 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.


Key words： Biological products； ; Co-production； ; Cleaning validation； ; HBEL

Cite this article

荣 刘 .

Specialty and Common Issues of Cleaning Validation for Biological Products Co-production

[J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2026 , 28(4) : 493 -493-496 . DOI: 10.1009-0959.2025.120006

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