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Home > News > Industy News > Pharmaceutical raw materials production enterprises shall strictly execute GMP

Pharmaceutical raw materials production enterprises shall strictly execute GMP

  On August 2,, the state food and drug supervision bureau held a press conference, issued the strengthening of the supervision and administration of pharmaceutical raw materials according to the relevant provisions of the "(hereinafter referred to as the regulations). The provisions made clear the pharmaceutical producing enterprises, pharmaceutical raw materials production enterprises, the supervision department their respective functions and duties, has been clear about the pharmaceutical excipients regulatory mode, set up the information openness, extension supervision, social supervision mechanism, increase the illegal behavior crackdown.
 
   The provisions made clear the first drug preparation production enterprises and pharmaceutical raw materials production enterprise responsibility, emphasizing the pharmaceutical preparation production enterprise is the drug quality, all because of the illegal use of medicinal materials cause drug quality problem, drug preparation production enterprise must bear the main responsibility. Drug preparation production enterprise must ensure that purchased pharmaceutical raw materials quality, and improve the quality management system, strengthen pharmaceutical raw materials supplier audit, to the use of pharmaceutical raw materials quality strictly, and the main pharmaceutical raw materials supplier quality association signed.
 
  For the implementation of pharmaceutical excipients supervision responsibility, strengthen the whole process supervision, the provisions suggested that drug regulators to pharmaceutical excipients implementing the classified management, the strict drug registration to declare to the requirements of pharmaceutical raw materials, pharmaceutical raw materials to strengthen the standard management.
 
  For new pharmaceutical raw materials and safety risk of higher pharmaceutical raw materials through a licensing management, namely production enterprise shall obtain the pharmaceutical production license, breed must obtain registration license; For other accessories shall adopt the filing management, namely production enterprise and its product for the record. A licensing management breed directory by GuoGuJu organize, batch announced. Various drug regulatory department should carry out supervision responsibility, strengthen within their respective administrative areas drug preparation production enterprise's daily supervision, within their respective administrative areas pharmaceutical raw materials production enterprises to carry out daily supervision, or according to the drug preparation production enterprise supervision and inspection of the problems discovered in pharmaceutical raw materials to production enterprise for extension inspection. Drug regulatory authorities at all levels should strengthen the pharmaceutical raw materials of the prison