Analysis of key inspection points for biological product production equipment
In recent years,prominent issues have been found in the production equipment during on-site inspections of biological products at home and abroad.The inspection of biological product production equipment is based on the provisions of Good Manufacturing Practice(GMP)standards for drug production.This article summarizes and analyzes the inspection points of sterile biological bulk and finished product production equipment,formulation production equipment,and single-use system,and lists typical problems in biological product inspection at home and abroad.It explores ways to improve the inspection effectiveness of biological product production equipment in various inspections and self-inspections,and also provides reference for further strengthening the management of production equipment in the biological product manufacturers.
NETL
NSTL
万方数据
