The new rules take the lead! The first general technical requirements for production of monoclonal antibody products at home and abroad

The national group information platform issued the group standard "general technical requirements for production of human recombinant monoclonal antibody products" jointly drafted by Shanghai drug review and verification center of Shanghai Drug Administration and Shanghai Pharmaceutical Industry Association on November 28, 2019, which will be implemented from January 1, 2020 The group standard "general technical requirements for production of human recombinant monoclonal antibody products" is applicable to monoclonal antibody production During the whole process of commercial production, the clinical trial drugs prepared according to GMP requirements can be implemented with reference This is the first on-site inspection guide for the production of human recombinant monoclonal antibody products in China, and also the "strictest" on-site inspection guide for the production of human recombinant monoclonal antibody products in the history of regulatory authorities after the implementation of the "Drug Administration Law" since December 1, 2019, which complements the domestic and foreign on-site inspection on the production of human recombinant monoclonal antibody products at the regulatory and technical levels Blank, further improve the long-term mechanism of mAb drug supervision, this paper analyzes the main contents of group standards and "general technical requirements for production of human recombinant mAb products" China's standardization system and management system came into being in the 1980s For a long time, the standards have been divided into four levels: national, industrial, local and enterprise standards The first three standards are formulated and approved by government departments The enterprise standards are only implemented within the enterprise, and the makers are exactly the most dynamic market subjects With the high-quality development of economy and society, the government Due to the long period of formulation, the government led Standard cannot be adjusted in time according to the market situation, resulting in the repeated absence of standards In order to adapt to the market changes and formulate the standards corresponding to the market demand as soon as possible, the society, association, enterprise or research institute voluntarily cooperate to draft and formulate a common and repeated standard, which is called group standard 。 These group standards have played a very positive role in promoting technological innovation, standardizing market order and leading industry development, and gradually become a useful supplement to the official standard system According to the notice on printing and distributing the regulations on the management of group standards (Guo Biao Wei Lian [2019] No 1) jointly issued by the National Standardization Commission and the Ministry of Civil Affairs on January 17, 2019, the definition of group standards is "the standards jointly formulated by legally established social organizations to meet the market and innovation needs and coordinate the relevant market themes" Before the formulation of group standards, full investigation and demonstration shall be carried out, and the formulation process shall be transparent, technical requirements shall not be lower than mandatory standards, and feasible; at the same time, it is stipulated that the implementation method of group standards is "agreed by group members or voluntarily adopted by the society in accordance with the provisions of the group" With the rapid development of human recombinant monoclonal antibody products industry, Shanghai has been in the leading position in the development pattern of domestic monoclonal antibody drugs, which also brings great challenges to the supervision of monoclonal antibody products At the beginning of 2019, Shanghai Pharmaceutical Industry Association, with the purpose of service industry development, helped promote the high-quality development of relevant industries, and Shanghai Pharmaceutical review and verification center and relevant weight of Shanghai pharmaceutical regulatory bureau The strategic cooperation of Grade-A enterprises has actively contributed to the formulation of the group standard "general technical requirements for the production of human recombinant monoclonal antibody products" With the purpose of improving regulatory performance through scientific regulatory methods, led by the Department of biological drugs of Shanghai drug review and verification center of Shanghai food and drug administration, Shanghai Pharmaceutical Industry Association, experts in the industry and several leading enterprises have jointly drafted "human use" The draft of general technical requirements for the production of recombinant monoclonal antibody products has been discussed and revised for many times to form the final group standard This group standard aims at the hot issues in the production of recombinant monoclonal antibody products for human use, comprehensively identifies the risk points in the whole process of the production of recombinant monoclonal antibody products for human use through extensive discussion, and puts forward the corresponding general production technology It is required to provide a group standard with operability for the production enterprises of human recombinant monoclonal antibody products It can not only improve the production capacity of the industry, but also greatly improve the regulatory efficiency of the regulatory agencies 1 Main chapters 2 Scope of application 3、 Drafting unit and drafter 4 Principles of general technical requirements for production of recombinant monoclonal antibody products for human use 5 Personnel inspection points 6 Key points of plant and equipment inspection 7 Key points of material management inspection 8 Key points of production and quality control inspection 9 Key points of quality management inspection