on November 3, the food and drug supervision bureau news spokesperson, administration recently received food and drug verification research institute of China (in court, similarly hereinafter) report, check out changchun longevity in the drug sampling inspection biotechnology co., LTD., production batch number is 201605014-01, wuhan institute of biological products co., LTD. The production batch number is 201607050-2 of the DPT vaccine titer indicators do not conform to the prescribed standards.
data diagram (for figure/visual China)
after reception, food and drug supervision bureau jointly with the national health and family planning commission immediately organize experts, and notice to relevant provinces on October 29, asked around to do a good job of disposal of unqualified vaccine. One is ordered to find out flow to enterprise. Via checking, changchun longevity biological technology co., LTD. Production of the batch vaccine for a total of 252600, all sold to shandong province center for disease control and prevention; The wuhan institute of biological products co., LTD production batches of vaccine in 400520, the centers for disease control and prevention, 190520 cigarettes sold to chongqing, sold to hebei province center for disease control and prevention, 210000. The second is to immediately stop using unqualified products. 3 it is to order the vaccine production enterprise report 2 batches unqualified vaccine delivery inspection result, the retention samples to test, unqualified reason seriously find titer. Four is sent to the team for two enterprises to carry out the investigation, and on-site production system compliance checks. All five are extracting the two enterprise production in the period of validity of the DPT vaccine test samples, inspection conclusion 6 to 8 weeks.
, prompt, a spokesman for the 2 batches the DPT vaccine potency index is unqualified, may affect the immune protective effect, but has no effect on human body safety. National health and family planning commission and three provinces of family planning department of health is organizing experts to the 2 batches vaccine to evaluate the protective effect of, take corresponding measures to properly handle according to the results of the evaluation; Health family planning department timely deployment of vaccine for 3 provinces and cities, ensure the normal order of the vaccination.
spokesman said that in accordance with the pharmaceutical administration law and other laws and regulations requirements, vaccine production enterprises must be listed for each batch of vaccine safety, efficacy test for all projects, such as self-inspection after qualified court issued by the listed in the check. Courtyard in the check in accordance with the relevant provisions, report to the group of the enterprise issued by the vaccine, the safety index inspection lot by lot, the titer effectiveness index according to the international practice random test 5%. As issued by batch records, the 2 batches of vaccine safety indexes accord with standard, titer effectiveness index is beyond the scope of sampling inspection.
spokesman said, since 2008, the state department of pharmaceutical product of sampling observation of 944 batches sampling plan, the percent of pass is 99.6%. The 2 batches the DPT vaccine titer indicators unqualified reason and conclusion, need according to the survey of the inspection, investigation and validity period of vaccine sample inspection results after comprehensive analysis, we will publish to the society about the information in time.
spokesman said, according to the Chinese center for disease control and prevention, the DPT vaccine is effective means to prevent pertussis, diphtheria, tetanus. Since the 1970 s into the immunization, pertussis, diphtheria, tetanus, incidence of a disease continues to decline, no diphtheria cases have been reported since 2007, the incidence of pertussis in the sixties and seventies of the last century 100-200/10, fell to below the current of 0.5/10.
spokesman stressed that the pharmaceutical production enterprise need to bear all legal responsibilities for public quality. All pharmaceutical producing enterprises must be in accordance with the approved by the state technology standard production, strict drug production quality management standard (GMP), to ensure continued compliance, conduct the whole process of all data are true, complete and traceability. All vaccine products must be after the inspection report issued by batch, the enterprise to the authenticity of product inspection report of production, product sample bear legal responsibility.
spokesman said, the food and drug supervision bureau for pharmaceutical production enterprise is located provincial food and drug supervision departments strengthen the daily supervision. Food and drug supervision bureau will continue to strengthen the listed products for inspection, sampling inspection and production were at the scene investigation found that the quality of the safety problems in time, handed over to the public security organs shall be investigated for criminal responsibility according to the alleged crime.
(the original title for the food and drug supervision bureau news spokesperson DPT vaccine titer indicators unqualified product disposal situation,)