July 20, 2016，CFDA issued a new regulations document "Decision of the State Food and Drug Administration on Modification & LT; Drug Operation Quality Management & GT; State Food and Drug Administration Order No. 28)。

 

  Review of the revision of the new version of the "Specifications for the Management of Drug Operations"，The "Specifications for the Management of Drug Operations" (the Ministry of Health of the People's Republic of China on June 1, 2013 (the Ministry of Health No. 90) implemented by the Ministry of Health began，A total of twice has been revised so far。The first time was July 1, 2015，"Regulations on the Quality Management of Drug Operations" released by CFDA (State Food and Drug Administration Order No. 13)，The second time stake betting appis Order stake betting appNo. 28 of the General Administration。

 

  So，After two revisions，"Specifications for the Management of Drug Operations" (GSP) What happened to the content? According to the author's understanding，Summary as follows:

 

  1 Camp Enterprise Data Collection Changes

 

  In the first revision of the "Drug Business Quality Management Specification" (GSP) on July 1, 2015，Adjustment Main content is the requirements for the collection of first camp enterprises，Replace the annual inspection of the business license to & rdquo; to & ldquo;，Adaptation to the industrial and commercial department to adjust the annual report system of the business license。

 

  After adjustment of this data，Drug business enterprises need to revise the enterprise quality management system document，Corresponding adjustment of the data collection requirements of the first camp enterprise，and timely collect this data review and archive。Another，According to the "Opinions of the General Office of the State Council on accelerating & ldquo; Three Certificate One & RDQUO; Registration System Reform" (National Office [2015] No. 50)，The data collection of the first camp，Adjustment to & ldquo; business license、Tax registration、Copy of the organization code certificate & rdquo;。

 

  2 & ldquo; Related requirements for vaccine business enterprises & rdquo; adjust to & ldquo; vaccine distribution enterprise requirements & rdquo;

 

  March 2016，Due to a vaccine incident，Vaccine Quality Management has attracted great attention from the governing departments of the state，In April 2016, the State Council revised the Regulations stake online sports bettingon the Management of Vaccination stake betting appand Prevention (State Council of the People's Republic of China No. 668)，It is stipulated that vaccine manufacturers directly distribute the second type of vaccine to the county -level disease prevention and control agency，or entrusted to have a cold chain storage、Enterprise delivery of transportation conditions，Reduce vaccine multiple operation circulation，Reduce due to transportation、The risk of vaccine changes caused by improper storage temperature and humidity monitoring。

 

  This newly revised "Specification of Drug Management Quality Management" (GSP)，Contents that adapt to the new management regulations of the State Council，Strict supervision of vaccine quality management，Business enterprises with the scope of vaccine business and commissioned by vaccine manufacturers，Strictly need to configure the corresponding personnel。

 

  3 Electronic regulatory system is adjusted to a drug traceability system

 

  February 20, 2016，CFDA issued the "Announcement of the General Administration on suspending the implementation of the relevant provisions of the relevant provisions of the Pharmaceutical and Electronic Supervision of the Pharmaceutical No. 1" (2016 No. 40)，Seminaned work -related work related to drug production and operation enterprises。During the suspension，Multiple drug operating enterprises have also consulted the author，Do you still need to continue the national electronic regulatory code & ldquo; see the code scan，Data upload & rdquo; work? Is it really completely canceled the electronic supervision code，So how to achieve drug traceability after canceling?

 

  Stake Sports BettingThis newly revised "Specifications for the Management of Stake Sports BettingDrug Business" (GSP)，The largest content of the adjustment is the relevant regulations of the national electronic supervision，After the adjustment of the post -adjustment regulations, the new word eye & ldquo; drug traceability & rdquo;，How to implement the pharmaceutical business enterprise to implement the drug traceability system for the drug circulation link，Newly revised the "Specifications for Quality Management of Drugs" (GSP)，Clear & ldquo; Enterprises should be purchased at drugs、Storage、Sales、Transportation and other links take effective quality control measures，Make sure the quality of the medicine，and establish a drug traceability system in accordance with relevant national requirements，Implementation of drugs traceable & rdquo; & ldquo; Enterprises should establish a computer system that can meet the requirements of the entire process of management and quality control，& rdquo;。& rdquo;

 

  4 Enhanced cold chain management

 

  This newly revised "Specification of Drug Management Quality Management" (GSP)，Reinforcement for refrigeration、Frozen drugs temperature and humidity control requirements，Clear refrigerator、Frozen drugs are storage、During the transportation process，It must be configured with corresponding facilities and equipment，Make sure the whole process of cold chain management。Same，The purpose is to reduce the risk of changing the quality of cold chain production due to the inadequate implementation of the temperature and humidity control of the operating enterprise due，Ensure the safety of the life of patients。

 

Current "Specifications for the Management of stake sports betting appDrug My stake betting appBusiness"、Draft revised on February 20、The official release of the formal release after the new revision