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New crown virus vaccine manufacturer dispatched inspector advanced training class to start

New crown virus vaccine manufacturer dispatched inspector advanced training class to start

  • Categories:Company News
  • Author:
  • Origin:State Drug Administration
  • Time of issue:2021-07-08
  • Views:0

(Summary description)In December 2018, the State Affairs Office of the Central Committee of the People's Republic of China issued the "Opinions on Reforming and Improving the Vaccine Management System" and made a top-level design for dispatching inspectors to vaccine manufacturers. In June 2019, the 11th meeting of the Standing Committee of the 13th National People's Congress deliberated and passed the "Vaccine Management Law", which required the dispatch of inspectors to vaccine manufacturers from the legal level.

New crown virus vaccine manufacturer dispatched inspector advanced training class to start

(Summary description)In December 2018, the State Affairs Office of the Central Committee of the People's Republic of China issued the "Opinions on Reforming and Improving the Vaccine Management System" and made a top-level design for dispatching inspectors to vaccine manufacturers. In June 2019, the 11th meeting of the Standing Committee of the 13th National People's Congress deliberated and passed the "Vaccine Management Law", which required the dispatch of inspectors to vaccine manufacturers from the legal level.

  • Categories:Company News
  • Author:
  • Origin:State Drug Administration
  • Time of issue:2021-07-08
  • Views:0
Information

  In December 2018, the State Affairs Office of the Central Committee of the People's Republic of China issued the "Opinions on Reforming and Improving the Vaccine Management System" and made a top-level design for dispatching inspectors to vaccine manufacturers. In June 2019, the 11th meeting of the Standing Committee of the 13th National People's Congress deliberated and passed the "Vaccine Management Law", which required the dispatch of inspectors to vaccine manufacturers from the legal level. In July 2019, the State Food and Drug Administration issued the "Guiding Opinions on Sending Inspectors to Vaccine Manufacturing Enterprises" to supervise and guide provincial drug regulatory agencies to carry out inspections. During the "Safe Drug Month" in 2019, with the strong support of the Ministry of Human Resources and Social Security, the Drug Supervision Department of the State Food and Drug Administration and the Advanced Training Institute of the National Food and Drug Administration successfully held the first advanced training class for inspectors dispatched by vaccine manufacturers. In September 2020, when the first round of dispatch is about to be completed, the Drug Supervision Department of the State Food and Drug Administration organized a symposium in Chengdu to summarize the experience of dispatched inspections and deploy a new round of dispatched inspections.

  Since the outbreak of the new crown pneumonia, General Secretary Xi Jinping has personally guided and deployed, and the Party Central Committee and the State Council have made a series of work arrangements. The quality and safety of the new crown virus vaccine is related to the health and life safety of the people, and ensuring quality and supply are the biggest political tasks for supervision of drugs after the market is currently and in the future. Among them, the creative deployment of the inspection work is an important part of the supervision of vaccines after the market and ensuring the quality and safety of large-scale production.

  The advanced training class for inspectors dispatched by the new crown virus vaccine manufacturer of the National Medical Products Administration has once again received the full assistance of the Ministry of Human Resources and Social Security, and is included in the national professional and technical personnel knowledge update project by 2021. On June 22, sponsored by the Drug Supervision Department of the State Food and Drug Administration and undertaken by the Advanced Research Institute of the State Food and Drug Administration, an advanced training class for inspectors stationed in new coronavirus vaccine manufacturers was reopened to improve the professional skills of vaccine production and inspection. Improve the professional ability of dispatched inspectors for the new crown virus vaccine, and strengthen the quality supervision of the new crown virus vaccine.

  In the past two years, dispatched inspectors have done a solid job in the factory, followed up the entire process of vaccine production, regularly issued defect feedback sheets to the companies stationed in, supervised the rectification and correction of the company, and realized the closed-loop management of the problem; actively understood the company's production inspection plan, Deviation investigation and handling conditions, key material procurement and management requirements, cooperate with the Provincial Drug Administration to study and judge potential risks, promote the implementation of main responsibilities of enterprises, and improve the quality management system. Because the plant-based inspectors can promptly detect the signs of hidden risks, quickly point out to the company and put forward suggestions for rectification and improvement, and report major issues to the higher authorities in a timely manner, thus effectively ensuring the quality and safety of vaccines.

  The seminar emphasized that the dispatched inspection work should attach great importance to the common problems found in previous supervision and inspections, adopt the “one company, one policy” and “implement policies according to needs” method, pay close attention to key parameters, key procedures and key processes, and strengthen the investigation and analysis of potential risks. Research and judge, supervise and urge enterprises to effectively implement the main responsibilities.

  The advanced training class was presided over by the main person in charge of the Advanced Research Institute of the State Drug Administration. The main person in charge of the Drug Supervision Department attended the opening ceremony and gave a speech. The relevant comrades of the Ministry of Human Resources and Social Security delivered speeches. The training course lasts for 5 days. Supervisors from the Drug Registration Department of the State Drug Administration, the Drug Regulatory Department, the China Food and Drug Administration, the Drug Evaluation Center of the State Drug Administration, and the Food and Drug Inspection Center of the State Drug Administration will issue the batch Sampling, dispatching inspection points, new coronavirus vaccine production process and quality work points, post-marketing change management, etc. are systematically explained. The teaching format includes not only face-to-face instruction by experts, exchange and sharing of experience in inspections by vaccine companies, but also on-site training. The new crown virus vaccine production companies (including the commissioned packaging companies) sent inspectors and business backbones from the drug regulatory bureaus of Beijing, Tianjin, Hubei and other provinces in charge of related work to participate in the study.

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