Analysis and consideration on quality management characteristics of cell therapy product manufacturing
YAN Ruo-xi
Abstract：Cell therapy products is the most specialized and complicated products in the quality management field of advanced technology products.This article combs and studies the regulatory guidelines for the production quality management of cell therapy products.By integrating typical production processes and characteristics of production elements associated with these products,we analyze and discuss the unique production quality management from six critical systems:quality management system,production system,facilities and equipment system,laboratory control system,material system,packaging and labeling system.We aim to provide reference to cell therapy industry,especially product manufacturer,to further improve pharmaceutical quality system.This work also serves as reference for inspections and quality audits related to these types of products.
Keywords：cell therapychimeric antigen receptor T cell productsadvanced therapy medicinal productsmedicine production quality managementgood manufacturing practice inspection
Publication Date：2025-06-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：9( 1121-1129 )