完善实验动物废物处置质量管理体系的思考:以中国食品药品检定研究院为例

Reflection on Improving the Quality Management System for Experimental Animal Waste Disposal:National Institutes for Food and Drug Control as an Example

科技发展是推动人类社会前进的巨大动力,而实验动物资源是生命科学、医药等领域科技发展的条件保障。但在开展医药研发、检验检测等实验过程中,使用实验动物产生的废物也为城市管理带来了新的考验。废物的分类、回收、有效利用和生物安全危害等问题接踵而至,对法规、标准、规范等的制定提出了与时俱进的要求。质量管理体系建设是检验检测机构管理的地基和框架,具备较强的操作性和检查性,可以不断提升管理水平,加强基础管理的稳定性。随着各层级新的管理办法出台,很多单位现行的质量管理体系内关于实验动物废物管理的相关内容欠妥,存在未明确非医疗机构实验动物废物处置流程、实验动物废物分类不准确、不同分类的废物未能按照不同方式处置等问题。本文针对目前存在的问题,梳理了中国食品药品检定研究院质量管理体系需要增加或者删改的流程,并制订了现行有效的标准作业流程,在如何加强监督管理方面提出了切实可行的措施,并开创性地把6S管理内容纳入质量管理体系中。因此,针对实验动物废物的管理应从完善质量管理体系的角度出发,从源头做好废物分类和管理,有效控制生物危害,最大限度地减少环境污染,为可持续发展创造条件。

Science and technological advancements drive human progress,with laboratory animals serving as essential resources for developments in life sciences and medicine.However,the waste generated by these animals presents new challenges for urban management.Issues such as classification,recycling,effective utilization,and biohazard elimination must be addressed,necessitating the development of regulations,standards,and norms to keep pace with advancements.The construction of quality management system is the foundation and framework for the management of inspection and testing organizations.It should have strong operability and inspectability,enabling continuous improvement of the management level and enhancing the stability of basic management.However,current quality management systems often lack clarity in managing laboratory animal waste,including undefined disposal processes for non-medical institutions,inaccurate waste classification,and inadequate disposal methods for different waste categories.This paper addresses these challenges by identifying necessary processes to be added or removed in the quality management system of National Institutes for Food and Drug Control,developing effective SOPs,proposing practical measures to strengthen supervision and management,and integrating 6S management principles into our quality management system.In conclusion,effective management of laboratory animal waste should be centered on improving the quality management system,emphasizing waste classification and management at the source,controlling biological hazards,minimizing environmental pollution and promoting conditions for sustainable development.