Business Agency, February 14th News The State Food and Drug Administration released the "Drug Production Quality Management Specification (Revised in 2010)" on the 12th。This revision after 5 years、New version of the new version of the drug production quality management specifications of the two public opinions will be implemented from March 1。
 
As part of the quality management system，Drug production quality management specifications Stake Sports Bettingare Stake Sports Bettingthe basic requirements of drug production and quality management，The aimed at minimizing the pollution in the production process of drug production、Cross pollution and confusion、Error and other risks，Ensure that continuously and stable production of medicines that meet the predetermined and registered requirements。
 
New version of drug production quality management specifications a total of 14 chapters、313 items，Compared to the quality management specifications of drug production revised in 1998，A large increase in length。Sun Xianze, Director of the Director of the Division of the State Food and Drug Administration, said，my country's existing pharmaceutical manufacturers show more overall、Small、San、Low pattern，Low production concentration，Insufficient innovation ability。Implement the quality management specifications of the new version of the drug production，Requirements to the development of the national strategic emerging industries and transforming economic development methods，It is conducive to promoting the resources of the pharmaceutical industry to focus on superior enterprises，Eliminate backward productivity，It is conducive to adjusting the pharmaceutical economic structure，To promote industrial upgrading，It is conducive stake sports betting appto stake betting appcultivating companies with international competitiveness，Accelerate the entering the international market。
 
According to an introduction，The main characteristics of the new version of the drug production quality management specifications include: strengthening the construction of drug production quality management system，greatly improving the requirements for the quality management software of the enterprise; comprehensively strengthening the quality requirements of employees; refinement of operating regulations、Production records and other document management regulations，enhanced guidance and operability; further improved drug safety guarantee measures。
 
Where，Drug safety guarantee measures，New version of drug production quality management specifications introduce quality risk management concepts，Purchase at raw and auxiliary materials、Production process change、Degree treatment in operation、Investigation and correction of finding problems、Monitoring of drug quality after listing，Added supplier audit、Change control、Correction and preventive measures、Product Quality Review Analysis and other new systems and measures，Manage and control the risks that may occur in various links，Active prevention of quality accidents。
 
It is reported，From March 1，New Drug Production Enterprise、Drug production enterprises newly built (change、Expansion) The Stake Sports BettingMy stake betting appworkshop shall meet the requirements of the new version of the drug production quality management specifications。Existing pharmaceutical manufacturers will give a transition period that does not exceed 5 years，and according to the degree of product risk，Requires the requirements of the new version of the drug production quality management specifications according to the category。
 
At the same time，The State Food and Drug Administration is developing the implementation of the implementation of the new version of the drug production quality management specifications，and will be released in the near future。Relevant departments of the State Council will strengthen communication and coordination，Research and formulation related policies，Promote the smooth implementation of the standardized quality management of new version of the drug。
 
It is understood，my country's first promulgation of drug production quality management specifications in 1988，During the period, two revisions were revised in 1992 and 1998。As of June 30, 2004，my country has achieved the goals produced under the condition that all raw materials and preparations meet the standards of drug production quality management。