Analysis on the situation of drug GMP certification inspection for Shandong Province in 2015
HAN Ying
BAI Jianxue
XU Dan
CAO Hongyan
HU Jingfeng
CHAI Fayong
Abstract：Good Manufacturing Practice( Revised 2010)had been formally promulgated and implemented for five years. However,there were still various weakness for certain pharmaceutical enterprises in the production quality manage-ment from the analysis on the situation of the certification inspection in 2015. This paper aimed to discover the outstanding problems existing in pharmaceutical production enterprises for the industry through the comparative analysis of the annual inspection defect items in 2015 and 2014. At the same time,this paper also provided improvement suggestion for pharmaceu-tical enterprises.
Keywords：GMP certificationDefective itemsAnalysisSuggestion
Publication Date：2016-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 427-430 )