Q: What problems have been discovered during the flight inspection of Changchun Changsheng Biological Company? What measures have been taken?
answer:According to the clue, from July 6th to 8th, the State Drug Administration and the Jilin Provincial Food and Drug Administration will conduct flight inspections on Changchun Changsheng Biotechnology Co., Ltd. (hereinafter referred to as Changchun Changsheng Biological Co., Ltd.); July 15th, the state The Food and Drug Administration and the Jilin Provincial Bureau formed an investigation team to conduct comprehensive investigations; on July 15, the State Food and Drug Administration issued the "Notice on Changchun Changsheng Biotechnology Co., Ltd. illegal production of freeze-dried human rabies vaccine."
Initial inspections revealed that Changchun Changsheng Biotech Co., Ltd. fabricated production records and product inspection records, and arbitrarily changed process parameters and equipment. The above acts are a serious violation of the relevant provisions of the Drug Administration Law of the People's Republic of China and the "Good Manufacturing Practices for Pharmaceutical Products" (Drug GMP). The State Food and Drug Administration has ordered enterprises to stop production, recover the GMP certificate for drugs, recall the rabies vaccine that has not been used, and file a case investigation with the Jilin Provincial Bureau. The suspected crimes are transferred to the public security organs for criminal responsibility. This flight inspection has not been shipped and listed for sale, and all products have been effectively controlled.
On July 22, the State Food and Drug Administration deployed a comprehensive inspection of the national vaccine production enterprises. On July 25, based on the full coverage tracking inspection of 45 vaccine production enterprises nationwide in early 2018, the national regulatory force was organized. The inspection team sent a full-process and full-chain inspection of all raw materials, production, inspection, and batch issuance of all vaccine manufacturers to ensure the safety of the people.
Q: How was the problem of unsatisfactory titer of DTP vaccine announced on November 3, 2017? What is the current situation of vaccine flow and control?
answer:The former State Food and Drug Administration received a report from the China Food and Drug Administration Research Institute (hereinafter referred to as the Central Inspection Institute). The batch number of the Changchun Changsheng Biological Company was detected in the sample sampling test of 201605014-01, and the Wuhan Institute of Biological Products limited liability. The company's (hereinafter referred to as Wuhan Biological Company) batch number of 201607050-2 Baibai broken vaccine titer does not meet the standard.
The General Administration of Food and Drug Administration and the former National Health and Family Planning Commission immediately organized experts to study and judge, and issued notices to relevant provinces and cities to require all localities to do unqualified vaccine disposal. The first is to order the company to find out the direction. After investigation, Changchun Changsheng Biological Company produced a total of 252,600 batches of vaccines, all of which were sold to Shandong Provincial Center for Disease Control and Prevention; Wuhan Biotech produced a total of 400,520 batches of vaccines, which were sold to 190,520 of Chongqing Municipal Center for Disease Control and Prevention. It was sold to 210,000 Hebei Provincial Center for Disease Control and Prevention. The second is to immediately stop using substandard products. The third is to order the vaccine manufacturer to report the results of the factory inspection of 2 batches of unqualified vaccines, re-inspect the samples, and carefully find out the reasons for the unqualified price. The fourth is to send an investigation team to conduct investigations on the two companies and conduct on-site production system compliance inspections. The fifth is to take samples of all the white vaccination vaccines produced by the two companies within the validity period for inspection. The vaccines involved have all been sealed and the company has completed the recall.
Changchun Changsheng Biotech Co., Ltd. has not resumed the production of DTP vaccine since last year. After the rectification of Wuhan Biotech Co., Ltd., the Central Inspection Institute conducted a titer measurement on its 30 batches of Baibai Broken Vaccine, and all the results were in compliance with the regulations, and combined with on-site inspection to resume production.
Q: What measures does China take to ensure the quality and safety of vaccine products?
answer:China has established a comprehensive life cycle monitoring system covering the vaccine “R&D—production – circulation – vaccination”, has a relatively complete vaccine regulatory system, regulatory system and standard management, and has established a scientific and rigorous vaccine registration and approval system, and implemented internationally advanced standards. The GMP of the drug and the strict quality management standard of the drug administration, all the listed vaccines were administered by the national batch, and a vaccination abnormal reaction monitoring report system was established.
In terms of batch issuance, in order to ensure the safety and effectiveness of biological products such as vaccines, the drug inspection agencies conduct data audits, sample inspections and issuance before each batch of products are put on the market. This supervision and management is an international regulation of biological products such as vaccines. The practice is listed by the World Health Organization as one of the key functions of governments to regulate vaccine biological products. Since December 2001, China has issued batches of five kinds of planned immunization vaccines, including Baibai, BCG, polio vaccine, measles vaccine and recombinant hepatitis B vaccine. Since January 1, 2006, all vaccines have been issued in batches. It has played an important role in regulating the production of enterprises, improving product quality, and promoting the orderly development of the industry.
In terms of vaccine production supervision, the State Drug Administration Department organizes annual coverage inspections of vaccine manufacturers. First, follow-up inspection of vaccine production quality control in accordance with GMP requirements for drugs, Chinese Pharmacopoeia requirements, and registration standards. Second, conduct flight inspections based on risk signals collected from batch issuance, national sampling, and adverse reaction monitoring. According to the defects found in the inspection, the company shall take measures such as rectification, warning letters, suspension of batch issuance, recall of related products or suspension of production.