Consideration on critical quality attributes determination of Chinese materia medica preparations
10.7501/j.issn.0253-2670.2019.17.003
- Author:
Xiao-Xia ZHAO
1
Author Information
1. Center for Drug Evaluation, National Medical Products Administration
- Publication Type:Journal Article
- Keywords:
Chinese materia medica preparation;
Critical quality attributes (CQAs);
Medicinal components;
Medicinal substances;
Production quality control;
Quality standards
- From:
Chinese Traditional and Herbal Drugs
2019;50(17):4008-4012
- CountryChina
- Language:Chinese
-
Abstract:
In this paper, through the analysis of the key issues in the confirmation of the critical quality attributes (CQAs) of traditional Chinese medicine preparations, it is proposed that the determination of the CQAs should fully consider factors such as the efficacy, safety, nature of the drug substance, requirements of formulation and overall requirements of drug quality control. Complete quality control items that can characterize the properties of drugs should be extracted to provide a basis for the establishment of process control and drug quality standards.
