Research Of Unannounced Inspection In Pharmaceutical Manufacturing Enterprises And Its Enlightenment To Enterprise Quality Improvement

The drug is a special commodity used for the prevention,treatment and diagnosis of human diseases.Its function dictates that it can only be classified as qualified or unqualified,not ranked to different grades.From the "Thalidomide" event in the 1960 s to the "Qieryao" event,the "Xinfu"event,the "MTX" event,and the "poisonous capsule" event that took place in recent years,the people paid a terrible price every time.They not only damaged the life and health of the people,but also seriously hurt the government's law enforcement authority and credibility,posing severe challenges to drug safety supervision.Ensuring drug safety is urgent.Pharmaceutical manufacturing enterprises are the manufacturers of drugs.The situation of pharmaceutical manufacturing enterprises determines the nature of medicine:to save or to harm people.Drug safety is dependent on drug manufacturers.Strengthening the regulation of drug safety has to start from strengthening the supervision of pharmaceutical production enterprises.Continuously improving the supervision ability,enhancing the regulatory effect,and ensuring that drug manufacturers can meet the public demand of qualified drugs is an issue in urgent need of studying and solving.This paper analyses the list of withdrawn GMP certificates issued on the website of the China Food and Drug Administration and the drug manufacturer inspection report from 2014 to the end of 2017.The paper seeks common defects from various types of production enterprises.The most common defect is false record and data reliability problem.In terms of traditional Chinese medicines pharmaceutical manufacturing enterprises,in addition to false record and data reliability problem,other problems include feeding not in accordance with prescriptions or reduce feeding,outsourcing extracts,illegally adding and add original powder directly.Defects of Aseptic preparation manufacturing enterprises are changing key operations processes without authorization changes and lacking qualification and validation for corresponding parameters.Problems of traditional Chinese medicines Pieces pharmaceutical manufacturing enterprises include outsourcing herbal pieces,direct selling without inspection,unqualified production equipment,not equipped with facilities and testing instruments corresponding to the production,and operations beyond scope.Problems of API manufacturing enterprises are feeding not in accordance with registered processes,insufficient supplier audit,selling outsourced raw materials,and so on.Problems of chemical medicine manufacturing enterprises lie more in file management,such as inapplicable or uncontrollable cleaning files.Other problems include cross contamination in co-production,unsuitable plant equipment,etc.Through the analysis of the unannounced inspection situation,this paper seeks the development direction for the supervision of pharmaceutical manufacturing enterprises,and it wants to provide reference for government supervision,enterprise development and public supervision.The author hopes the paper can help constantly improve the unannounced inspection system and reduce the occurrence of drug safety incidents.