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    Home > Medical News > Latest Medical News > Official announcement! Here comes the administrative penalty of longevity biology, 9.1 billion yuan!

    Official announcement! Here comes the administrative penalty of longevity biology, 9.1 billion yuan!

    • Last Update: 2018-10-17
    • Source: Internet
    • Author: User
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    On October 16, the State Drug Administration and Jilin food and Drug Administration strictly punished Changchun Changsheng Biotechnology Co., Ltd (hereinafter referred to as "Changchun Changsheng company") for illegal production of rabies vaccine According to the decision on administrative punishment, Changchun Changsheng company has the following eight illegal facts: first, mixing and compounding different batches of original solution, and then re fabricating the production batch number of the original solution after blending and compounding; second, changing the production batch number or actual production date of some batches of products involved in the case; third, using the expired original solution to produce some products involved in the case; fourth, not following the prescribed methods for the finished product The potency of the preparation was determined; the fifth was that the centrifuge used for the production of drugs was not put on record according to the regulations; the sixth was to destroy the original production records and make up false batch production records; the seventh was to swindle the biological products batch certificate by submitting false information; the eighth was to destroy the hard disk and other evidences to cover up the illegal facts According to the decision on administrative penalty, the above-mentioned acts violate the drug administration law of the people's Republic of China and its implementing regulations, as well as the laws, regulations and rules such as the drug production quality management standard, the drug production supervision and management measures, and the biological product batch issuance management measures According to the relevant provisions of the jurisdiction of administrative penalty, the State Drug Administration and Jilin food and drug administration respectively imposed a number of administrative penalties on Changchun Changsheng company The State Drug Administration revokes the drug approval certificate of rabies vaccine (gyzz s20120016) of Changchun Changsheng company; revokes the batch issuance certificate of biological products involved in the case, and imposes a fine of 12.03 million yuan Jilin food and Drug Administration revokes its drug production license; confiscates 1.89 billion yuan of illegally produced vaccine and illegal income, and imposes a fine of 7.21 billion yuan three times the value of illegally produced and sold goods, with a total fine of 9.1 billion yuan; in addition, it makes a decision that Gao Junfang and other directly responsible persons shall not engage in drug production according to law Administrative punishment for business activities If a crime is suspected, the judicial organ shall investigate the criminal responsibility according to law On the same day, three other related announcements were issued by eugenics, the details of which are as follows: On October 16, 2018, Changchun Changsheng Biotechnology Co., Ltd (hereinafter referred to as "Changchun Changsheng"), a wholly-owned subsidiary of Changsheng Biotechnology Co., Ltd (hereinafter referred to as "Changchun Changsheng"), received the decision on administrative penalty issued by Jilin food and Drug Administration (jsjyhfj [2018] No 17), The relevant information is hereby announced as follows: 1 The main contents of the punishment document are examined From January 2014 to July 2018, your company illegally produced and sold 748 batches (including sub batches) of freeze-dried human rabies vaccine (Vero cell) (hereinafter referred to as "involved products") The details are as follows: 1 For all the products involved in the case that your company produced from January 2014 to July 2018, two or more batches of original solution are used to mix and prepare in the production process, and then the production batch number is made up again for the original solution after blending and mixing From January 2014 to January 30, 2015, your company's preparation of semi-finished products with the above-mentioned mixed batch of raw solution did not meet the requirements of "ordinary cases" in the third part of Chinese Pharmacopoeia (2010 version), that is, semi-finished products refer to "a batch of raw solution diluted and prepared into a uniform intermediate product" From December 1, 2015 to July 15, 2018, your company's preparation of semi-finished product-2 - with the above mixed batch of raw solution does not conform to the provisions of "ordinary cases" in the third part of Chinese Pharmacopoeia (2015 version), that is, semi-finished product refers to "a batch of raw solution is diluted to prepare a uniform intermediate product for sub packaging to the final container" The above behaviors of your company violate the drug administration law of the people's Republic of China (revised in 2013), Article 9, paragraph 1 of the drug administration law of the people's Republic of China (revised in 2015), "drug manufacturing enterprises must organize production in accordance with the drug production quality management specifications formulated by the drug regulatory department of the State Council in accordance with this Law", Article 10, paragraph 1, "except for traditional Chinese medicine drinks" In addition to the processing of tablets, pharmaceuticals must be produced in accordance with the national pharmaceutical standards and the production process approved by the pharmaceutical regulatory department under the State Council, and the production records must be complete and accurate "Article 184 of the pharmaceutical production quality management specification (revised in 2010)" all pharmaceutical production and packaging shall be operated in accordance with the approved process procedures and operating procedures, with relevant records To ensure that the drugs meet the specified quality standards and meet the requirements of drug production license and registration approval " According to Article 49, paragraph 3, item 6 of the drug administration law of the people's Republic of China (revised in 2013) and Article 49, paragraph 3, item 6 of the drug administration law of the people's Republic of China (revised in 2015), "other products that do not conform to the provisions of drug standards", the semi-finished products prepared with the above-mentioned stock solution shall be treated as inferior drugs 2 From 2016 to 2018, your company changed the production batch number or actual production date of 184 batches of products involved in the case Among them, 118 batches changed the production date backward, which extended the product validity The above behaviors of your company are in violation of the first paragraph of Article 9 of the drug administration law of the people's Republic of China (revised in 2015), "drug manufacturing enterprises must organize production in accordance with the drug production quality management specifications formulated by the drug regulatory department under the State Council in accordance with this law", and the fourth article of the drug production quality management specifications (revised in 2010), "enterprises shall strictly implement these specifications" Fan, adhere to the rules of honesty and trustworthiness, prohibit any false and deceptive behavior According to Article 49, paragraph 3, item 1 of the drug administration law of the people's Republic of China (revised in 2015), "change of validity period" and "change of production batch number" in Item 2 of the drug administration law of the people's Republic of China, the products involved in the above change of production batch number and production date shall be punished as inferior drugs 3 According to stp-01-3-02-004, revision No 00, 01, 02, the intermediate quality standard of freeze-dried human rabies vaccine (Vero cell) of your company, the purified stock solution shall be kept for no more than 12 months From February to March 2017, your company produced three batches of products involved in the case with the expired stock solution produced in 2016 According to the approval of your company by the State Food and Drug Administration on January 23, 2017 Division's "manufacturing and verification regulation of freeze dried human rabies vaccine (Vero cell)", the original solution of your company's freeze dried human rabies vaccine (Vero cell) after purification shall be preserved for no more than 9 months From March to April 2018, your company produced 9 batches of products involved in the case using the expired stock solution produced in 2017 In addition, your company violates the above regulations on manufacturing and testing of freeze-dried human rabies vaccine (Vero cell), and uses some unqualified stock solution with low antigen content after secondary concentration and detection to meet the preparation standard The above behaviors of your company violate the first paragraph of Article 9 of the drug administration law of the people's Republic of China (revised in 2015), "drug manufacturing enterprises must organize production in accordance with the drug production quality management specifications formulated by the drug regulatory department under the State Council in accordance with this Law", and the first paragraph of Article 10, "except for the processing of Chinese herbal pieces, drugs must be prepared in accordance with the national drug standards and the State Council The production records must be complete and accurate for the production process approved by the pharmaceutical supervisory and administrative department "Article 184 of the pharmaceutical production quality management specification (revised in 2010)" all pharmaceutical production and packaging shall be operated in accordance with the approved process procedures and operation procedures and have relevant records, so as to ensure that the pharmaceutical products meet the specified quality standards and conform to the pharmaceutical products " Requirements for production license and registration approval " 4 According to the regulations on manufacturing and testing of freeze dried human rabies vaccine (Vero cell) approved by the State Food and Drug Administration in 2012 and the State Food and Drug Administration in 2017, your company shall carry out titer determination and thermal stability test on the finished product No heat stability test has been carried out for 387 batches of products involved in the case produced by your company from 2016 to 2017, and the method of titer determination for 382 batches of finished product preparation does not conform to the above manufacturing and verification regulations The above behaviors of your company violate the first paragraph of Article 9 of the drug administration law of the people's Republic of China (revised in 2015), "drug manufacturing enterprises must organize production in accordance with the drug production quality management specifications formulated by the drug regulatory department under the State Council in accordance with this Law", and the first paragraph of Article 10, "except the processing of Chinese herbal pieces, drug-4-must be in accordance with the national drug standards and state affairs The production process approved by the drug regulatory department of the hospital shall be carried out Production records must be complete and accurate ", Article 12" drug manufacturers must conduct quality inspection on the drugs they produce; they do not meet the National Drug Standards The inspection of materials and products at different stages of production shall at least meet the following requirements: (1) the enterprise shall ensure that the drugs are subject to the full inspection in accordance with the method of registration and approval 5 According to your company's technical specification for freeze dried human rabies vaccine (Vero cell) (Code: stp-02-04-001, revision No.: 01-09), since August 5, 2012, your company has produced freeze dried human rabies vaccine (the model of Vero cell centrifuge is DL-6M, and the manufacturer is Changsha Xiangyi Centrifuge Instrument Co., Ltd Since November 28, 2017, your company has replaced the model of centrifuge used with d-35720 osteroides continuous flow machine, and the manufacturer is German termofisher company, which has not been filed as required The above behaviors of your company violate Article 46 of the measures for the supervision and administration of drug production (Order No 14 of the State Food and drug administration, revised in 2017) "if the conditions and current situation of key production facilities of drug manufacturing enterprises change, it shall be reported to the food and Drug Administration of the province, autonomous region and municipality directly under the central government where it is located for the record within 30 days of the change The food and Drug Administration of the municipality directly under the central government shall carry out inspection as required 6 From January 2014 to July 2018, during the production of the products involved in the case, the original records shall be destroyed immediately after the completion of production and the products pass the inspection, and false batch production records shall be prepared In the batch inspection records of the products involved in the case, your company has made up the final product potency measurement records and thermal stability test records of the relevant batches Your company requires Changchun Yisi Laboratory Animal Technology Co., Ltd to issue a false laboratory animal sales document in early July 2018 for the purpose of making up animal test records The above behaviors of your company violate the drug administration law of the people's Republic of China (revised in 2013), the first paragraph of Article 9 of the drug administration law of the people's Republic of China (revised in 2015), "drug manufacturers must organize production-5-products in accordance with the drug production quality management specifications formulated by the drug regulatory department of the State Council in accordance with this Law", and the first paragraph of Article 10, "except traditional Chinese medicine" In addition to the processing of decoction pieces, the drugs must be produced in accordance with the national drug standards and the production process approved by the drug regulatory department under the State Council, and the production records must be complete and accurate "Article 4 of the code for the quality control of drug production (revised in 2010)" enterprises shall strictly implement this code, adhere to honesty and trustworthiness, and prohibit any false and deceptive behavior ", Article 184 "
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