摘要
本文从外用药物制剂实施现状出发,通过在数据调研和大量文献收集的基础上,对从药品生产质量管理规范(GMP)的发展及其在我国的推行历史角度,分析并阐述了现阶段外用药物制剂GMP的实施状况,并对某制药集团属下25家药企实施2010版GMP的现状进行调查分析。由于历史发展的原因促使药品管理尚未完全规范以外,GMP标准的过时性和落后性影响了我国GMP工作的深入实施。只有保证了日常的GMP实施,才能有效地保证药品生产的高质量、低风险,有效地促进药品生产的质量保障,使药品真正达到国际水平,走向现代化、国际化。
This article embarks from the current topical pharmaceutical preparations, based on data through extensive literature research and collecting on from the development and implementation of GMP in China and the development of history, analyzes and expounds the topical drugs GMP implementation status at present stage, in the meantime it places an analysis on the investigation of the current situation to 25 drug firms in the implementation of the status quo version of the 2010 GMP from a pharmaceutical group. Due to the historical development prompted Drug Administra-tion has not entirely specification, GMP standard staleness and delayedness influenced the in-depth implementation of the GMP work in China. Only to ensure the daily implementation of GMP, can effectively guarantee the pharmaceutical production of high quality and low risk, effectively in promoting quality assurance of pharmaceutical production, thus to make drugs really reach the international level, modernization and internationalization.
出处
《中国医药导报》
CAS
2015年第1期138-140,共3页
China Medical Herald
关键词
外用药物制剂
现状分析
GMP
Topical pharmaceutical preparations
GMP
Analysis of current situation
