Analysis of differences and implementation suggestions between the appendix of pharmaceutical excipients and the good manufacturing practice for pharmaceutical excipients
WANG Xin
WU Fuzhao
BAI Jianxue
Abstract：Pharmaceutical excipients play a crucial role in the effectiveness of drugs,and the National Medical Products Administration's newly released"Good Manufacturing Practice for Drugs(Revised in 2010)"appendix on pharmaceutical ex-cipients has a significant impact on promoting the production quality of pharmaceutical excipients.To understand the new re-quirements for the production of pharmaceutical excipients in the new appendix,provide reference for the quality improvement of pharmaceutical excipient production enterprises,and promote the improvement of excipient quality management level.This article compared and analyzed the"Appendix to Medicinal Excipients"with the"Quality Management Standards for Medicinal Excipients Production"released in 2006,and refers to the current requirements of drug GMP to provide implementation sug-gestions for the new version of the"Appendix to Medicinal Excipients"for excipient production enterprises in China.
Keywords：Pharmaceutical excipient appendixQuality management systemQuality managementPharmaceutical ex-cipientGood manufacturing practice for drug
Publication Date：2025-10-30
Online Publishing Date：2025-11-26(First online date of this platform, not the publication date of the document)
Pages：4( 1037-1040 )