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The "Administrative Measures for the Management of Quality Management of Drug Production Quality Management" revised
Release time: 2011-08-15 & nbsp & nbsp & nbsp Source:

August 2,The State Food and Drug Administration released a revised "Measures for the Management of Quality Management of Drug Production Quality Management"。


Stake Sports BettingIn stake online sports bettingorder,Further regulates inspection and certification behavior,Promote the Implementation of "Specifications for the Management of Drug Production (Revised in 2010)",The State Administration organized amendments to the "Administrative Measures for the Management of Quality Management of Drug Production"。New revised management measures to apply for drug GMP,Acceptance and review,On -site inspection,Approval and issuance certificate,Tracking Check,"Drug GMP Certificate" management and other contents make clear stipulation。The Measures A total of 7 chapters,40 items,Perform from the date of release。


Management measures to point out,The State Administration is in charge of the national drug GMP certification management work,Responsible for injection、Radioxids、GMP certification and tracking inspection of drugs such as biological products and other drugs; responsible for the coordination of imported drug GMP overseas stake betting appexamination stake sports betting appand national or regional drug GMP examination。Provincial Drug Supervision Department is responsible for in -depth injection in its jurisdiction、Radioxids、Other drugs outside the biological product GMP certification and tracking inspection work, and the drug GMP inspection work entrusted by the National Bureau。The State Administration is responsible for evaluating the quality management system of drug certification inspection institutions。


New production scope of newly opened pharmaceutical manufacturers or pharmaceutical manufacturers、New workshop,The application of drug GMP certification shall be applied for in accordance with the provisions of the Implementation Regulations of the Drug Management Law。Pharmaceutical manufacturers who have obtained the "Drug GMP Certificate" should be 6 months before the validity period of the certificate,Re -apply for drug GMP certification。Drug Supervision Department stake online sports bettingresponds to a pharmaceutical manufacturer Stake Sports Bettingholding the "Drug GMP Certificate" for tracking and inspection。"Pharmaceutical GMP Certificate" performed at least one tracking inspection during the validity period。


The management method also clarifies several situations that should be recovered by the drug regulatory department to recover the "Drug GMP Certificate",That is: the enterprise (workshop) does not meet the requirements of the drug GMP; the enterprise is ordered to discontinue production and rectification for violating drug management regulations; other situations that need to be recovered。