Notice on safety protection and management inspection of vaccine production strains

Beijing, Hebei, Liaoning, Jilin, Shanghai, Jiangsu, Zhejiang, Henan, Hubei, Guangdong, Sichuan, Yunnan and Gansu food and Drug Administration (Drug Administration): In order to further strengthen the management of vaccine production strains, ensure the quality and safety of vaccine, it is decided to carry out special inspection on biological safety protection and management of vaccine production strains The notice is as follows: first, it is of great significance to strengthen the management of vaccine production strains for maintaining their biological characteristics and ensuring the quality and safety of vaccine products All relevant provincial food and drug administrations shall further improve their awareness of strengthening the biosafety protection and management of vaccine production strains, further implement the regulatory responsibilities, clarify the regulatory responsibilities, improve the regulatory capacity, and effectively carry out the special inspection of biosafety protection and management of vaccine production strains of vaccine production enterprises within their jurisdiction II The inspection work shall be carried out in stages by combining the enterprise self inspection with the supervision and inspection of the regulatory authorities (1) enterprise self inspection Vaccine manufacturers shall carefully carry out self inspection according to the requirements, rectify the problems found in the inspection, and fill in the information form of vaccine production virus species according to the requirements of Annex 1 The vaccine manufacturer shall complete the self inspection before the end of July 2011, and report the self inspection and rectification as well as the information form of bacteria and virus species for vaccine production to the local provincial food and Drug Administration in a timely manner (2) on site inspection by the regulatory authority The provincial food and Drug Administration of the place where the vaccine manufacturer is located shall be responsible for the on-site inspection of the biosafety protection and management of vaccine production strains Each relevant provincial food and drug administration shall, according to the biological safety protection and management self inspection of vaccine production bacteria and virus species of vaccine production enterprises, appoint GMP inspectors and other relevant personnel who have participated in the WHO vaccine quality risk management training course to carry out on-site inspection The inspection contents shall include: three-level library management of bacteria and virus species, detection of bacteria and virus species, correspondence between receiving records and production process, production instructions, storage mode and substantive management, etc See attachment 2 for inspection points The on-site inspection shall be completed before the end of August 2011 (3) supervision and spot check by the regulatory authorities The State Administration of food and Drug Administration will conduct supervision and random inspection on the biological safety protection and management of vaccine production strains of vaccine manufacturers according to the on-site inspection conducted by relevant provincial food and drug administrations and the work plan of GMP follow-up inspection of vaccine manufacturers in 2011 The supervision and random inspection shall be organized by the drug certification administration center of the State Administration III relevant requirements (I) vaccine manufacturers should take a positive attitude, fully participate in the rectification of biological safety protection and management of vaccine production strains, and carefully cooperate when accepting on-site inspection to provide real information Those who intentionally evade, conceal facts and provide false records will be dealt with seriously according to law (II) all relevant provincial food and drug administrations shall seriously organize and carry out on-site inspection on Biosafety protection and management of bacterial and toxic species for vaccine production In case of any potential safety hazard found in the inspection, the enterprise shall be ordered to rectify immediately If necessary, the enterprise can be ordered to stop production for rectification, take back the GMP certificate and other measures to ensure the quality and safety of vaccine products All relevant provincial food and drug administrations are requested to report the work of special inspection on biosafety management of vaccine production strains together with the information form of vaccine production strains filled in by the enterprise to the National Bureau before September 15, 2011 If there are any problems or suggestions in the special inspection, please contact the drug safety supervision department of the State Administration in time Contact person: Cui Yesong, Liu Jingqi Tel: 010-88330850, 88330864 Fax: 010-88330854 attachment: 1 Information form of bacterial and toxin species for vaccine production? 2 Inspection points Office of State Food and Drug Administration Appendix 1: information table of bacterial and virus species for vaccine production Appendix 2: key points of inspection I a complete seed batch system (original seed batch, main generation seed batch and working seed batch) shall be established for the production of bacterial and virulent seeds The seed batch system should have complete data such as the original source, identification of characteristics, lineage, whether the virus is a single pure microorganism, production and cultivation characteristics, and the best preservation conditions The establishment, maintenance, preservation and verification of the seed batch system of bacterial seed should meet the requirements of Pharmacopoeia of the people's Republic of China 2 The suitability of seed batches shall be confirmed by the consistency of successive batches of products Seed batches should be established, preserved and used in a manner that minimizes the risk of contamination or variation III The number of generations (times of multiplication and times of generations) between seed batch and finished product shall be consistent with the provisions in the approved registration data, and shall not change with the change of production scale IV seed batch shall be established in an appropriate controlled environment to protect seeds and operators In the establishment of seed batches, other active or infectious materials (such as viruses, cell lines or cell lines) should not be handled in the same area or by the same person at the same time V only approved personnel are allowed to carry out seed batch operation, which shall be supervised by competent personnel 6 The stability and recovery of seed batch shall be recorded Storage containers shall be sealed, clearly labelled and stored at the proper temperature The inventory account shall be kept properly The temperature of the cold storage shall be recorded continuously, and the storage conditions of liquid nitrogen shall be monitored properly Any deviation from storage conditions and corrective actions shall be recorded 7 Different seed batches shall be stored in such a way as to avoid mistakes, confusion or cross contamination The seed batch for production shall be stored in different special warehouses under the specified storage conditions, and only the designated personnel are allowed to enter, so as to avoid the risk of total loss 8 All containers containing the main seed batch or working seed batch shall be treated equally during storage Any container taken from the seed batch for use shall not be returned to the storage.