In 2016, the flying inspection of drug administration was unprecedentedly strengthened! Which will be checked by flight?

Source: the recent flying inspection of cypress blue on April 18, 2016 is very fierce Why do you say so? In Guangdong Province alone, three pharmaceutical companies were withdrawn from GMP or put on file for investigation due to unqualified flight inspection within two weeks On March 22, the flight inspection notice issued by Guangdong food and drug administration showed that Guangdong Hengcheng Pharmaceutical Co., Ltd violated the drug administration law of the people's Republic of China and the relevant provisions of GMP, and Guangdong Administration decided not to issue the GMP certificate of the company's new factory (the old factory GMP The certificate has expired), and the relevant suspected illegal behaviors shall be investigated and punished by the inspection department according to law On March 31, Guangdong food and Drug Administration issued another notice of flight inspection Shenzhen Huayao Nanfang Pharmaceutical Co., Ltd., a subsidiary of North China Pharmaceutical Co., Ltd., was found to have three major defects in flight inspection and was suspected of illegal production organization At present, it has been transferred to the Inspection Branch of Guangdong Provincial Bureau for handling according to law On April 13, Guangdong food and Drug Administration issued a further notice of flight inspection, indicating that Zhuhai Yibang Pharmaceutical Co., Ltd has withdrawn the GMP certificate of powder injection because it does not meet the GMP requirements It is worth noting that this is the eighth pharmaceutical company that was withdrawn from GMP due to reporting in 2016 It may be lamented that the speed is too fast Three flight inspection bulletins have been issued within two weeks There is no doubt that the bugle of the year of flying inspection has been sounded At this time, the efficiency is not high How can we afford the high-intensity work of the drug supervision department and the positive report of the masses (although I think most of them are insiders)? On April 16, the 29th China Pharmaceutical Industry Summit Forum hosted by China Pharmaceutical Enterprise Management Association and planned and implemented by cypress blue was held in Shanghai Relevant leaders of the State Food and drug administration also attended the meeting and introduced GMP certification decentralization, drug inspection, flight inspection, tracking inspection, etc In 2016, the strength of flight inspection will be unprecedented At the meeting, the leader said that in 2015, the State Administration of flight inspection sent 47 inspection teams, involving 58 enterprises Enterprises, including Chinese herbal pieces, Chinese herbal extracts, Chinese herbal preparations, chemical APIs, chemical pharmaceutical preparations, biochemical drugs and blood products, which are also the types of enterprises that focused on inspection last year So far this year, the flight inspection situation has not been counted, but there is no doubt that the intensity of flight inspection is also very strong After the decentralization of drug supervision, there is another factor that makes the strength of flight inspection continue to strengthen: the establishment of a full-time inspector team Because the current inspectors are not full-time, there are often cases where inspectors cannot be selected, and few inspectors are really available In the future, a full-time inspector team will be established, and public recruitment will be made to the society Personnel with production practice experience will be recruited from pharmaceutical enterprises as inspectors The National Bureau may also refer to the regulatory measures of the United States Drug Administration, continue to increase the intensity of tracking flight inspection, promote the inspection quality system, reduce the difference in inspection level, and form a national regulatory game Which will be checked by flight? The so-called flight inspection is that there is no time limit Unlike the follow-up inspection meeting, which is publicized to everyone, the enterprise is also prepared Unlike the follow-up inspection, the flight inspection will be informed in advance, and the enterprise is also prepared There are several principles to start the flight inspection: 1 There are complaints or clues from other sources, indicating that there may be some quality safety risks 2 Some quality and safety risks are found in the inspection; 3 There may be quality and safety risks in the monitoring of adverse drug reactions 4 I have doubts about the application materials Some of the application materials are too good at first sight, or can't be reached at first sight 5 Suspected of seriously violating the requirements of quality management specifications 6 The enterprise has a serious record of non-compliance.