BEIJING, Jan. 3, according to the National Health and Family Planning Commission, State news website, recently, the State Food and Drug Administration of the State Health and Family Planning Commission informed about the progress of the investigation the case of hepatitis B vaccines. Informed that the inspection did not find Shenzhen Kangtai 17 day diet company in the production process and quality control issues 17 day diet affecting the quality of products, not found Conde credit 17 day diet quality problems produced by the hepatitis B vaccine. Informed that in 2013, 21 to 27 December, food and housing a second child and Drug Administration sent inspection teams to Shenzhen Kangtai company conducted a comprehensive inspection. Chinese Academy of Food and Drug test involves eight batches of Condé Company hepatitis B vaccine was tested. After two batches of inspection work on-site inspection and pre-censorship, Food and Drug Administration of the hepatitis B vaccine held a check inspection of judgments, meetings of experts invited to the World Health Organization vaccine, the vaccine well-known experts 17 day diet in the field of participants. After the inspection test experts judged the situation and agreed that the company's production site for Conde inspection and product testing process of scientific rigor, the result is true and reliable. Informed that the inspection team of four inspectors engaged in international drug GMP certification and expert inspection and quality control of the vaccine composition. On-site inspection, the inspection team focused 17 day diet on the existence of contamination and cross-contamination for the production process, if there is a change that may affect product quality and abnormal situations, the enterprise materials management, production management, process control, production workshop, quality control and various aspects of the quality assurance system, which may affect product quality in-depth and meticulous examination and collection of the relevant raw data. Inspection team focused on checking the eight batch batch batch production records and inspection records involving suspected abnormal reaction to vaccination, deviations, change, and all materials, intermediate products, semi-finished product testing and so on. Careful inspection team for nearly three years, 17 day diet compared to corporate annual reports retrospective analysis of product quality, environmental monitoring data SSDs, public works facilities and equipment operation, as well as the production process parameters, warehousing, cold chain transport and other documents and records. Informed 17 day diet that, after inspection, 17 day diet the inspection team that the firm produces a variety of hepatitis B vaccine does not exist with other varieties of line production cross-contamination. The hepatitis B vaccine enterprise quality standards, production procedures and processes prescriptions, 17 day diet procedures and records and other documents meet the requirements. Enterprise stable raw materials suppliers, three strains libraries required to manage the production and packaging process in accordance with approved procedures and operating procedures, related records and complete. Business-to-production process Internet marketing aseptic packaging area full implementation of dynamic monitoring, upon inspection of the monitoring data analysis, has led to contamination of the product was not found. Conde company inspection team that hepatitis B vaccine production and manufacturing quality control 17 day diet and registration verification procedures approved unanimously by the hepatitis B vaccine liquid, semi-finished products for quality review, the test results of eight batches of product, process parameters and production Other batches of product compared to its test results were within the acceptable range and stable, critical process parameters within a set range, production quality management in line with "Good Manufacturing Practice" 17 day diet requirements. 17 day diet The inspection found that the company did not affect the product quality problems in production and quality control process. Informed that the December 17, 2013, Chinese 17 day diet Academy of Food and Drug Testing of Hunan Food and Drug Administration inspection of Shenzhen Kangtai two batches of hepatitis B vaccine for testing. The two batches of samples were sex toys from Hengshan County, Hunan Province Center for Disease Control (batch 17 day diet C201207090), Changning 17 day diet City, Hunan Province Center for Disease Control (batch C201207090), Hanshou County CDC (batch C201207088), Hengshan in Hunan County ginkgo Center Hospital (Lot C201207090) and Changning City, Hunan Province, hospitals shade Town Center (lot C201207090), total 956. Hengshan County in which the samples, Changning and Hanson County CDC collected all the items have been tested, including: identification test, appearance, loading volume, pH, aluminum content, in vitro determination of relative potency, sterility test, abnormal toxicity test , bacterial endotoxin test; due to lack of Hengshan County ginkgo shade Changning Town Center Hospital and Health Center Inventory sample size, sample collection were checking security projects, including: identification 17 day diet test, sterility test, abnormal toxicity 17 day diet test, bacteria endotoxin inspection. Test results show that the two batches of samples are in line with corporate registration standards 17 day diet and national pharmacopoeia standards. Informed that the Chinese Institute of Food and Drug Testing for these two batches of samples to check the results 17 day diet with the same batch lot release the results of comparison, no significant change in the indicators, 17 day diet batch release test results are consistent with the results, indicating 17 day diet stable product quality. Informed that, from 2010 to 2013, Chinese Academy of Food and Drug test company for batch release a total of 346 Conde hepatitis B vaccine has been approved audit and inspection data, the results are in line with requirements and data between batches with good consistency, indicating that the production process is mature and stable. In order to ensure safe and effective vaccines, food and drug regulatory authorities for two consecutive years for random testing of hepatitis B vaccine market. 2011 extracted four companies 16 batches of hepatitis B vaccine, which the company Conde six batches of the vaccine; 2012 24 batches extracted four companies hepatitis B vaccine, which the company Conde four batches of vaccine. All samples taken were full-term test, the results are in line with regulations. Comprehensive review of the above test results and data analysis of the situation and found no quality problems Conde produced hepatitis B vaccine. Informed that in 2013, 13 to 19 December reported five cases of suspected hepatitis B vaccine inoculation Kangtai cases, four cases of deaths unrelated to determine the initial vaccination until after completion of the autopsy and other related work, will make the final diagnosis ; 1 case of severe have been discharged, the case does not exclude abnormal reaction caused by the vaccine (anaphylactic shock). Conde suspended after the entire hepatitis B vaccine, between December 20 to 31, the country has reported 13 cases of suspected hepatitis B vaccine inoculation 17 day diet Kangtai deaths before 17 day diet 20 December were vaccinated with hepatitis B vaccine. It is understood that at least eight cases of death cases there are clear reasons for the clinical diagnosis, parents see media reports, the suspect with the vaccination, and the request to re-diagnosis. Diagnosis again by the Expert Group, the current nine cases have been diagnosed, regardless of vaccination; other four cases preliminary judgment has nothing to do with the vaccination until after completion of the autopsy and other related work, will make the final diagnosis. Informed that more than 18 cases for epidemiological analysis found that patients showed a variety of clinical manifestations, the main causes of death include severe pneumonia, asphyxia, renal failure, severe diarrhea in children, necrotizing enterocolitis, meconium aspiration syndrome, Sudden infant death, congenital heart disease, the lack of identity; cases were distributed in nine different provinces 18 counties; except two cases in Hunan deaths (death was severe 17 day diet pneumonia and sudden infant death) inoculated 17 day diet with the same batch of vaccine, the remaining lot of different cases vaccines. In addition, the reported cases of child mortality and under-five deaths reported by the monitoring system constitutes no significant difference in infant death. Informed that the main cause of abnormal reaction suspected vaccination there are five species, including the quality of the vaccine inoculation operational problems, abnormal reaction of individual 17 day diet problems, heart problems 17 day diet and other ailments coupling reactions due to the problem. The survey is also the case around these problems started. The absence of reported cases of psychogenic reaction problems. From the survey results over the look, vaccination units and personnel qualifications meet the requirements, vaccine storage, transportation compliance, vaccination practices in line link. (Original title: two ministries: not found Conde hepatitis B vaccine produced quality problems exist)
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