The key points and common problem analysis for pharmaceutical research and development of biological products
ZHANG Ping
SONG Kai
Abstract：In the production and quality control of biological products,there are considerable variabilities and specific characteristics.Under the new regulatory framework for drug registration,on-site inspections serve as a crucial supervisory tool to facilitate the authenticity and traceability of data in biological products research and development(R&D),and to promote its industry standardization and high-quality development.Based on the characteristics of biological products and practical inspection experiences in recent years,this article summarized and analyzed the key focus points and common issues identified during the on-site inspections of the CMC(chemistry,manufacturing,and controls)research and development of biological products.The aim is to provide insights for biological products R&D and registration,as well as to offer reference for conducting related inspections.
Keywords：Biological productsPharmaceutical research and developmentKey points of inspectionPrescription design
Publication Date：2025-12-30
Online Publishing Date：2026-01-22(First online date of this platform, not the publication date of the document)
Pages：6( 1194-1199 )