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Self -check check again.
Release time: 2016-06-30 & nbsp & nbsp & nbsp Source: Anonymous
  June 21-22,The State Food and Drug Administration held a consistency evaluation meeting in Beijing,Deputy Director Wu Yan said at the meeting,To increase the verification of prescriptions and process changes。The words are just falling,A notice entitled "Notice on Further Strengthening the Supervision of Drug Production Technology" began to spread in the industry。
 
  Change production process without authorization will be discontinued
 
  It is understood,This notification is currently just a draft,Notification requirements,Each pharmaceutical company should conduct self -examination in response to the production process of each approved listing drug,Whether the content of the self -inspection is the consistent production process approved by the drug actual production process and the stake betting appstake online sports bettingregulatory department。If consistent,can continue to produce or import,and go to the local provincial pharmaceutical regulatory department for record。If it is not consistent,Then production or import must be stopped,and re -demonstrate。
 
  According to the state's precedent for circulation rectification now,It is estimated that after self -examination,Pharmaceutical companies will also accept strict checks。
 
  A pharmaceutical company's relevant person in charge said to Sai Bailan,After browsing the draft content,He thinks,For a pharmaceutical manufacturer,This is very terrible,Perform according to this file,Estimated January next year,Many medicines will be discontinued。
 
  He said,Currently for pharmaceutical companies,Exercise is to check,Death is profit。Many small and medium -sized pharmaceutical companies will operate regularly,There is no competitiveness in the face of profit。So,There is simplified production process、Tampered with non -compliance behaviors such as production technology。
 
  There are also industry insiders analyzed,Now,Beyond the frequent flying inspection,Coupled with the production technology of pharmaceutical companies and various inspections,After discontinuation of production and rectification,profit space has been repeatedly compressed,Small and medium -sized pharmaceutical companies may usher in a tide of closing door。
 
  Production process problems have already been stared at
 
  As early as 2007,The State Drug Administration Department has already proposed that the special concentration operation of the drug production link will focus on the production process inspection,Supervisor drug manufacturers produced in accordance with the approval process,Never allow any excuses,Change the production process and prescription stake betting appwithout authorization。
 
  stake sports betting appJune 3 this year,Food and Drug Review and Inspection and Inspection and Inspection and Inspection and Inspection and Inspection of the State Food and Drug Administration released the "2015 Drug Inspection Report",Report display,Drug flight inspection of 59 companies last year,Among them, 22 are recovered by the drug GMP certificate,6 Drug production licenses were revoked,3 have been filed for investigation。
 
  Where,It mentioned the storm of ginkgo leaves last year。In the storm,Guilin Xingda Pharmaceutical was found in a flying inspection that there was an illegal behavior such as changing the extraction process without authorization,And the pharmaceutical company also paid a heavy price for its own illegal acts。It has been punished by administrative punishment,and revoke the drug production license。
 
  Looking at the pharmaceutical company that has been collected this year's GMP,Many are also inability to get rid of the production process with unauthorized change of production technology。
 
  January this year,The State Food and Drug Administration released the "Tracking Inspection Notice of Longhai Natural Botanical Pharmaceutical Co., Ltd."。During the inspection, it was found that the serious violations of the company existed,It is included to produce alum vine hemorrhoids in accordance with the process of registering and declaration。Eventually stopping production、Pharmaceutical GMP certification is not passed。
 
  Let's talk about the recently,June 7th,The State Food and Drug Administration issued the "Notice on Chongqing Garrilin Pharmaceutical Co., Ltd. and Baiyun Shandong Thai Shangqiu Pharmaceutical Co., Ltd.。,Both pharmaceutical companies have serious illegal behaviors for the production of artificial stake sports betting appbeef and yellow raw materials,stake sports betting appWhere,​​Chongqing Garrilin Pharmaceutical Co., Ltd. did not strictly follow the "Artificial Beef Cyber ​​Craft Regulations"、Artificial Niuhuang Drug Registration and Application Information Production Process Production Artificial Niuhuang。Current,The above two pharmaceutical companies have been collected GMP、Recall Products、File case survey。
 
  There are still many examples similar to changing production processes in uniquely,I believe there is no need to explain one by one。
 
  The pharmaceutical industry will usher in a tide of compliance
 
  As early as the beginning of last year,The State Drug Administration announced the "Pharmaceutical Flight Inspection Measures (Draft)",Strict flight inspection has become a normal regulatory measure。Normalization of flight inspection、After strictness,Unsure pharmaceutical companies are discontinued、The number of GMPs that has been recovered has been increasing。
 
  According to the "Pharmaceutical Management Law of the People's Republic of China",Drugs must be produced in accordance with the production process approved by the National Drug Standard and the drug supervision and management department of the State Council。Drug production enterprises change the production process that affects the quality of drugs,It must be reported to the original approval department for review and approval。
 
  Tampered with the production process,Not only will it affect the effective ingredients of the medicine,It will also affect the efficacy of drugs,Then it has a adverse effect on the user。So,The compliance of pharmaceutical companies will be the next check -up focus of the drug supervision department,For those who have passed the new version of GMP but tampered with the process in the production Stake Sports Bettinglink、Covery reduction,It will stake sports betting appbe defeated during the strict flight inspection。
 
  Future,The compliance of pharmaceutical companies in my country will become the focus of attention。With all kinds of strict flying inspections,,It has formed a clear impact on the entire industry。For pharmaceutical companies,The price paid due to illegal production will also be inestimable。