无菌工艺模拟试验中常见问题和检查要点分析研究  

Typical observations and key points of inspection in aseptic processing simulation

作　　者：颜若曦 YAN Ruo-xi(Center for Food and Drug Inspection of NMPA,Beijing 100044,China)

机构地区：[1]国家药品监督管理局食品药品审核查验中心,北京100044

出　　处：《现代药物与临床》2022年第9期2135-2141,共7页Drugs & Clinic

摘　　要：无菌工艺模拟试验的评估内容涵盖了无菌操作全过程,是对药品生产活动无菌保证能力评估的有效方法,对其检查的常见问题包括工艺模拟、报告与记录、干预、模拟范围、污染调查与处理、模拟的次数与频次、模拟介质(培养基)等方面。在对无菌工艺模拟试验设计与方案制定、实施与执行、持续评估与再验证3个不同阶段进行重点分析基础上,就如何从程序文件规定、无菌工艺模拟试验方案、无菌工艺模拟试验报告与记录、无菌工艺模拟试验实施过程的视频和相关记录、生产现场情况、人员和关联内容等7个方面对无菌工艺模拟试验的检查重点进行了阐述。从药品检查角度对无菌工艺模拟试验进行分析,就如何在无菌药品检查及各类自检和外部审计中做好无菌工艺模拟试验相关内容的检查进行研究,以期促进无菌工艺模拟试验在药品生产企业中更科学合理的开展,更好地保证药品质量。The evaluation content of aseptic process simulation test covers the whole process of aseptic operation,which is an effective method to evaluate the sterility assurance ability of drug production activities.Common problems in the inspection of aseptic process simulation tests include process simulation,reporting and recording,intervention,simulation scope,contamination investigation and treatment,the number and frequency of simulations,simulation medium(culture medium),etc.Sterile process simulation test can be analyzed from three stages:design and program formulation,implementation and execution,and continuous evaluation and revalidation.Aseptic process simulation is evaluated from 7 aspects:procedure documentation,aseptic process simulation test plan,aseptic process simulation test report and record,video and related records of the implementation of aseptic process simulation test,production site conditions,personnel and related content.This article will analyze the aseptic process simulation test from the perspective of drug inspection,and elaborate on the inspection of relevant content in the sterile drug inspection,various self-inspection and external audit,hoping to promote the scientific and rational development of aseptic process simulation test in drug manufacturers,to better ensure the quality of medicines.

关 键 词：无菌工艺模拟试验 无菌药品 常见问题 检查要点 

分 类 号：R954[医药卫生—药学]