Five departments issued the General Requirements for Biosecurity in Vaccine Production Workshops

According to the website of the National Health and Health Commission, the National Health And Health Commission, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the State Administration of Market Supervision, the State Drug Administration on the 18th jointly issued the "General Requirements for Biosecurity in Vaccine Production Workshop" as a temporary emergency requirement to promote the production of the new crown vaccine during the prevention and control of the outbreak of new crown pneumonia.
the use of pathogenic microorganisms for vaccine production, there is a certain biosecurity risk, the need to ensure the quality of vaccines at the same time, to ensure the biosecurity of production activities. This document refers to the relevant laws and regulations and standards of biosecurity at home and abroad, closely combined with the requirements of drug production quality management norms, based on the biosecurity risks in the whole process of vaccine production to put forward biosecurity requirements.
is to grade the level of protection in the vaccine production workshop. Second, it is stipulated that for low/high biosecurity risk workshops, their production workshops and facilities, production equipment, verification and evaluation should be carried out in accordance with low/high biosecurity-related requirements. Third, there are clear requirements and measures for biosecurity. Fourth, the organization and personnel, document management, security management, security control and continuous improvement, etc. have made provisions and requirements.
paper proposes to grade the level of protection in the vaccine production workshop. According to the risk of the workshop involving pathogenic microbial operation, the level of biosecurity protection in the workshop is divided into the low biosecurity risk workshop and the high biosecurity risk workshop.
personnel, the document proposes that enterprises should set up biosecurity leaders, responsible for biosecurity management matters, when found that there are biosecurity risks, with the right to immediately stop related production activities. The person in charge of biosecurity shall have the corresponding professional knowledge, undergraduate degree or above in medicine, pharmacy and other related majors (or intermediate and above titles), and have more than 5 years of management experience in related fields. The person in charge of biosecurity and the person in charge of the workshop cannot be the same person.
requirements require enterprises to provide induction training and continuous training for all personnel in the workshop, and the contents of the training should be adapted to the job requirements. In addition to training in biosecurity theory and practice, there should be training in relevant regulations, responsibilities and skills for the respective positions, and the practical effects of the training should be regularly evaluated. Personnel engaged in highly pathogenic pathogenic microbial activities should be trained semi-annually.
the document points out that enterprises should establish and improve the biosecurity system on the basis of risk assessment, take security measures, and file a record with the local public security organs and accept the supervision and guidance of the public security organs. Biosecurity should be integrated into risk management to ensure effective management of pathogenic microorganisms, strains, potentially contaminated materials or wastes, with a management record. Where a highly pathogenic pathogenic microorganism leaks, is lost and stolen, robbed or other biological threats occurs, control measures shall be taken in a timely manner in accordance with the provisions of the emergency plan and reported in accordance with the provisions. In the event of a violation of biosecurity regulations, reports, records and investigations shall be carried out and, if necessary, appropriate measures taken.
During the prevention and control of the new crown pneumonia epidemic, this document, as a temporary emergency standard to promote the production of the new crown vaccine, only provides for the biosecurity requirements of the new crown vaccine production workshop, and other construction, management and operation must meet the relevant requirements of national laws, regulations and standards.