The Research Of Competence Model For Beijing-District GMP Inspector

Drug,is a special commodity,and people’s health level and life safety closely related.Therefore,the quality of risk and technical methods of using scientific and reasonable to reduce,prevent,or disperse control drugs,let people use drugs to treat disease,functional regulation,the damage is minimal,this is a serious issue facing the drug production supervision,we should attach great importance to.Good Manufacturing practice(hereinafter referred to as its English abbreviation GMP),is to ensure the production of pharmaceutical specifications and quality safety arising from.At present,many countries in the world generally use GMP to supervise and control the quality of pharmaceutical production enterprises,since the last century,China’s pharmaceutical industry overall software and hardware levels generally improve.But in recent years,China’s continuous occurrence of adverse events,has aroused great concern of the quality and safety of drugs and concerns.At present,the supervision of drug production enterprises in China is mainly carried out by GMP certification,which is carried out by drug GMP inspectors.So the quality of GMP inspectors directly related to the effectiveness of drug GMP certification.Therefore,how to effectively improve the drug GMP inspector’s ability and quality,how to effectively ensure the effectiveness of inspection of drug GMP inspector for pharmaceutical production enterprises,how to control the process in the regulatory changes of this,a series of problems that how to improve the importance of drug GMP inspector ability has become increasingly prominent.This paper takes Beijing City drug GMP inspector for the study sample,the drug GMP inspector for target,lack of quality standards for the reform of the management system of drug GMP inspector based on the lack of the status quo,research on the competency model to carry out the Beijing drug GMP inspector.The main research work is as follows:for our drug GMP inspector itself with state officials and technical experts of the general characteristics of the GMP and the inspector duties of clear Beijing drug GMP inspector should choose target competency;behavioral event interview,competency model building methods,according to the Beijing Municipal Drug GMP inspector positions.To construct the competency model of Beijing City drug GMP inspector,and based on the model analysis of drug GMP inspector qualification and excellent competency standards;questionnaire survey research of Beijing drug GMP inspector competence status,and the current situation of Beijing City drug GMP inspector inspector ability and competency standards were compared,obtained Beijing City drug GMP inspector competence status to meet the drug GMP inspectors qualified competency standards,But the inspector and excellent competency standards as well as the gap between the conclusion;to present the GMP inspector of Beijing excellent ability of drug and drug GMP inspector competency standards gap as the basis,put forward Beijing City drug GMP inspector management system reform process reform measures.Main innovation points and value:the research puts forward the competency goal of drug GMP inspector in Beijing.Using competency theory and other human resource management theories to establish the competency standards of drug GMP inspectors for the first time.This paper systematically studied the competency competency status of drug GMP inspectors in Beijing city for the first time,and put forward the overall model of drug GMP inspector management system reform in Beijing according to the actual situation.