Interpretation of"Technical guideline for quality control of manufacturing process of traditional Chinese medicine oral preparations production(trial)"
CHEN Xia
YANG Chang-ming
HAN Wei
QU Jian-bo
YANG Ping
CHEN Hao
Abstract：The manufacturing process of traditional Chinese medicine(TCM)is a critical link in ensuring the safety,effectiveness,stability and uniform quality of TCM products.Implementing effective quality control throughout the manufacturing process is an important means to guarantee drug quality.With the continuous development of TCM preparations,an increasing number of new technologies,methods and equipment are being applied in the field of TCMs research and production,further highlighting the importance of quality control in the production process.Recently,the"Technical guideline for quality control study of manufacturing process of traditional Chinese medicine oral preparations production(trial)"released by the Center for Drug Evaluation,NMPA,provides strong guidance for strengthening quality control of the production process based on the characteristics of traditional Chinese medicine and the actual research and development of traditional Chinese medicine.This paper introduces the background of drafting the guideline,and analyzes and interprets the basic principles and main contents of the guideline for reference.
Keywords：oral preparations of TCMsquality control of manufacturing processtechnical guidelinequality controllability
Publication Date：2025-11-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2241-2246 )