| The mission of implementing the Drug GMP is to ensure that the drug manufacturers can follow the scientific and systematic industry code and code of conduct to guarantee the drug quality and maintain the people safe and effective medication through managing the whole production process standardly.The Drug GMP of our country was introduced in the early 1980 s of last century,nearly 20 years later thanthe pharmaceutical industryof America.Ithas got obvious achievements after three decades of development.The drug qualityand comprehensive quality of drug manufacturershas been improved greatly by implementing Drug GMP.However,a series ofnotoriousdrug misadventures has occurredsuccessivelyin China for the past few years,which reveals various problemsin the pharmaceutical production processes of China.After reviewing a large amount of literature and learning form the implementation experience on pursuing GMP in foreign countries,this paper classifies,compares and analyzes the defects found in the inspectionfor GMP certificationof drugs,follow-up inspection and flight inspection carried out for blood products manufacturer of China with practical working experience of the author to find out reasons of defect formation,analysis and research strategies and provide recommendations for drug manufacturers to implement GMP.Meanwhile put forward somerationalization suggestions for blood product manufacturers to better implement GMP to ensure the quality of drugs.Firstly,this paper discusses the defects found in the inspections for 33 blood product manufacturers when they implement GMP with a statistical method.Make statistics on defects found in the inspections related to GMP for 33 sample enterprises random inspected in 2014,2015 and 2016.It was found that the main defects and general defects of some enterprises were still existed by pooling analysis and the quantity of those defects is large.Those defects are mainly appeared in those chapters like Quality Control and Quality Assurance,Documentation Management,Premises and Facilities,Production Management,etc.They make up more than 10%of the total number of defects,which shows that there are still various problems like that the quality system can't operate normally,the facility layout of workshop isn't proper orqualified,the document system isn't sound and the production managementisn't strict in the process of implementing GMP.Then analyze the 337 practical problems existed in 33 sample companies.Give examples for typical defects mainly existed in nine aspects like General Provisions,Quality Management,Organization and Personnel,Premises and Facilities,Equipment,Materials and Products,Qualification and Validation,Documentation Management,Production Management,Quality Control and Quality Assurance,etc.(GMP).Analyze reasons and provide countermeasures and suggestions.Finally think deeply to found out the source of those problems by summarizing the problems existed in the process of implementing GMP.Put forward some suggestions for implementing GMP combining on the realities of blood product manufacturers.The reasons why the enterprise have problems when implementing GMP: 1.The active consciousness is not strong when implementing Drug GMP;2.The essence of GMP has not been infiltrated intodrug manufacturing enterprise;3.The legal position of GMP is not high;The cost is low when the enterprise doesn't follow the regulation of GMP.According to the current situation of blood products manufacturer,put forward some supervision ideas: 1.Strengthen the source supervision;2.Supervise the dynamic state of enterprise through making full use of the information platform;3.Improve the extraction capacity of blood products to increase comprehensive utilization of plasma;4.Increase the yield of plasma to solve the problem of overcapacity;5.Abolish the certification system of Drug GMP and strengthen the inspection;6.Elevate the legal statusof GMP and increasethe penalties forviolations... |
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