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Drug flight inspection methods to solicit the views of the six cases started inspection

Number of visits: Date:2014-11-10 15:56:56

In order to regulate the activities of drug flight inspection, strengthen the supervision and management of drugs. November 2nd, the State Food and Drug Administration on the drug test approach (Draft) for public comment, the deadline for the feedback of December 5, 2014.
The so-called "drug flight check" is the pharmaceutical supervisory and administrative departments of the notice to surprise inspections or investigations for investigation of drug production, management and other aspects to carry out. A verification of complaints to report problems; investigation of drug quality risk; investigation of drug serious adverse events or groups of adverse events; investigate illegal violations; random supervision and spot checks. Other necessary flight test of drugs in six cases, you can start drug flight inspection. Flight test of drugs taken without prior notice, not to reveal the content inspection, not listened to the general report, do not arrange for reception, went straight to the scene, investigation and verification is examined units for the implementation of the real situation of drug control laws and regulations. According to the draft, to have verified the clues, the quality of the products exist security risks, or found not in conformity with the laws, regulations and standards and technical specifications of shall shooting and recording of related facilities, equipment, materials and other in kind and site conditions, make a copy of relevant documents, to the relevant personnel asked; when necessary, in accordance with the relevant provisions of the production record of investigation and on-site inspection record. Units and relevant personnel should be inspected in accordance with the requirements of the inspection team in a timely manner, to provide real and effective records, bills, documents and other related materials, open computer management system, not to refuse and hide. Draft requirements, do not fit or obstruct the inspections, refuses to provide or providing false materials, deliberately conceal the illegal production and management, the illegal violation facts a verified. In case of serious circumstances shall be given a heavier punishment. Suspected of a crime, the drug inspection departments in accordance with the relevant provisions of the notification or transferred to the public security organs.
Chinese Pharmaceutical Pharmaceutical Policy Research Center Executive Director Song Ruilin said with 2006 "on the issuance of the Interim Provisions on the drug GMP flight inspection notice" compared, both the biggest difference is the drug of the flight check into the daily check of the drug supervision and administration, ability and level of drug supervision and administration further mature and improve.
Song Ruilin said GMP is an important specification to guide pharmaceutical companies to ensure the quality of drugs. From raw materials to the whole process of production, GMP includes the most important point, but it is not all of the production of drugs. Now we have to check the GMP into a drug flight inspection, it is extended to the entire drug quality control system in the. Although compared to the current provisions of the drug flight inspection, the draft did not make a substantial change, but the standard flight inspection, strengthen drug regulation is the trend. The biggest difference is that the drug's flight inspection into the routine inspection of the whole drug control, our drug regulatory capacity and level to further mature, improve.

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