中国食品药品监管Issue(7)：114-121,8.DOI:10.3969/j.issn.1673-5390.2024.07.014
新形势下关于开展药品GMP符合性检查的思考
Reflections on GMP Compliance Inspections under the New Situation
曹鸿雁 1张杰 1赵杰 1柴发永 1柏建学 1周勇1
作者信息
摘要
Abstract
After the revision and implementation of the Drug Administration Law and the Drug Production Supervision and Management Rules,the concept of good manufacturing practice(GMP)compliance inspection was proposed.Taking Shandong Province as an example,GMP inspections applied by enterprises include renovation and expansion of production lines,site changes,commissioned production,etc.In addition,marketing authorization holders or drug manufacturing enterprises also undergo licensing inspections,registration checks,and post-market inspections.Frequent inspections pose new challenges to enterprises and inspection resources.This article focuses on laws,regulations and policies that form the basis of GMP inspections,as well as the dosage forms or types,inspection situations,and inspection demands displayed in a questionnaire survey conducted for Shandong enterprises.Combining actual inspections with principles of risk-based management,this paper explores opinions and suggestions for conducting GMP compliance inspections.关键词
药品生产质量管理规范/符合性检查/检查情形/风险管理Key words
good manufacturing practice/compliance inspection/inspection situation/risk management分类
医药卫生引用本文复制引用
曹鸿雁,张杰,赵杰,柴发永,柏建学,周勇..新形势下关于开展药品GMP符合性检查的思考[J].中国食品药品监管,2024,(7):114-121,8.
