Wuhan Biological Company's price failure baibai-breaking vaccine disposal verification team announced the progress of the work

Medicine sonnet August 11 in accordance with the requirements of the State Council, the State Drug Administration, together with the National HealthHealthCommittee and other departments formed a verification team on August 1 to Hubei, the 2017 discovery of Wuhan Biological Products Research Institute Co., Ltd(hereinafter referred to as Wuhan Biological Company) production number for 201607050-2 effect of non-conforming baibai vaccine disposal work to carry out verificationverification team arrived in Wuhan and held a plenary meeting to convey the spirit of learning the important instructions of General Secretary Xi Jinping and the request of Premier Li Keqiang, and decided to set up a comprehensive group, investigation team, replanting group, expert group and other working groups to carry out the verification work in an all-round wayThe verification team heard the report of the Hubei provincial government, provincial and municipal regulatory departments and Wuhan Biological Company, and through on-site investigation, access to documents, verification of file records, comparison data, interviews with relevant personnel, etc., restored the equipment failure site situation, verified the production and operation of the baibai-breaking vaccine, confirmed the flow of unqualified vaccines and make up the situation, groped the risks inherent in the enterprise, checked the daily supervision and law enforcement punishment of local regulatorsverified that the batch of substandard baibai-breaking vaccine was produced on July 19, 2016The shutdown was caused by a failure of the transmission chain of the sub-assembly equipment for 20 minutesDuring downtime, the distribution of the active ingredients of the batch of vaccines is uneven due to inadequate shaking of the semi-finished buffer tank prior to fillingEnterprise factory self-test, did not take into account the equipment failure may cause quality instability problems, did not carry out special inspection of the products installed in the fault time period, still in accordance with the conventional method of sampling, resulting in the results of the self-test price can not truly reflect the quality of the batch of vaccine sq.Prior to the listing of the batch of vaccines, the China FoodMedicinesAnd Verification Research Institute (hereinafter referred to as the Chinese Academy of Inspection) conducted random sampling of the vaccine batch issued by the index of effectiveness in accordance with the prescribed proportion, and did not draw the vaccine that was packed in the faulty time periodOn October 27, 2017, the Chinese Academy of Medicine found that the batch of diphtheria price 81IU / agent, the nationalstandardis not less than 30IU / agent; Pertussis effect price 2.8IU / agent, the national standard is not less than 4IU / agent, does not meet the regulationsverified, Wuhan Biological Company has recalled the batch of all unused vaccines, and the Wuhan drug regulatory authorities under the supervision of destruction The Chinese Inspection Institute carried out the inspection of other batches of Baibai-breaking vaccine of Wuhan Biological Company, and the quality indicators were qualified The two provinces and cities of Hebei and Chongqing, where the unqualified baibai-breaking vaccine flowed, have carried out replanting work in accordance with the requirements To date, 71 per cent and 75 per cent of the total number of children to be replanted have been completed respectively Considering that the vaccine should be given 4 doses at the age of 3, 4, 5 and 18 months respectively, the interval between the follow-up doses that have not yet been reseeded should be determined according to the actual vaccination of the child Therefore, it will take some time for the replanting work to be completed verification team determined that Wuhan Biological Company did not follow the production procedures Local regulators have problems with inadequate regulation The punishment for accidents is not strictly punished in accordance with the relevant regulations and regulations of the State
and regulations, and the administrative penalties are light verification team stressed that the next step, the State Drug Administration will work with relevant departments and local governments to urge enterprises to further rectification, in accordance with the law to seriously investigate the responsibility of enterprises and regulatory authorities, the implementation of replanting measures, early release of verification and processing results Other related follow-up work is under way