Interpretation of the Guideline for Pharmaceutical Excipients of Animal Origin
10.11665/j.issn.1000-5048.20220316
- VernacularTitle:《动物来源药用辅料指导原则》解析
- Author:
Chunmeng SUN
1
;
Lei CHEN
;
Yanan LI
;
Zonghua SONG
;
Zhaopeng YANG
;
Jiasheng TU
Author Information
1. 国家药品监督管理局药物制剂及辅料研究与评价重点实验室
- Publication Type:Journal Article
- Keywords:
pharmaceutical excipients of animal origin;
guideline;
quality control;
risk management;
life cycle
- From:
Journal of China Pharmaceutical University
2022;53(3):376-382
- CountryChina
- Language:Chinese
-
Abstract:
Pharmaceutical excipients of animal origin, an important part in pharmaceutical excipients, are widely used in pharmaceutical preparations.However, compared with the pharmaceutical excipients of other origins, pharmaceutical excipients of animal origin have more special requirements in many aspects, such as raw materials, production, quality control, storage, supervision, etc.Chinese Pharmacopoeia 2020 first included the Guideline for Pharmaceutical Excipients of Animal Origin, which introduces the basic ideas and technical requirements for the life cycle quality control of pharmaceutical excipients of animal origin based on the risk management concept.This article illustrates the specificity of the pharmaceutical excipients of animal origin, and interprets the main contents of this guideline in conjunction with relevant domestic and foreign regulations and technical documents, thereby providing comprehensive reference for the implementation of the guideline.
