As one of the key regulatory objects of the national drug administration, blood products, like vaccines, need to implement the batch issuance system of biological products. The "Administrative Measures for the Batch Issuance of Biological Products" (promulgated by the State Administration of Market Supervision and Administration No. 33 in 2020) implemented on March 1, 2021 clearly states that the batch issuance of biological products refers to the approval of the State Drug Administration for marketing. For vaccine products, blood products, in vitro diagnostic reagents for blood source screening, and other biological products specified by the State Drug Administration, before each batch of products is sold or imported, the activities of issuing certificates for batches that meet the requirements are reviewed and inspected by the designated batch issuing agency. Products that have not been issued in batches may not be marketed or imported.

After years of practical experience, the State Drug Administration has revised the appendix of blood products in accordance with Article 310 of the good manufacturing practice (revised in 2010), and announced Announcement No. 77 of 2020, which will come into effect on October 1, 2020.

In addition, in order to fully implement the main responsibility of blood product marketing license holders for product quality and safety, strengthen the supervision and management of blood product quality, and comprehensively improve the informatization level of blood product production and inspection, the General Department of the State Food and Drug Administration issued the blood product appendix (revised draft for comments) on December 26, 2023.

The State Food and Drug Administration issued the newly revised Blood Products Appendix Announcement (No. 70 of 2024) on June 11, 2024, which will be implemented from the date of issuance. The main content adds information and visualization of blood product production and inspection. Related requirements. Specifically, it includes: First, Article 25 of the Appendix adds the stipulation that blood product production enterprises urge plasma collection stations to use information-based means to truthfully record the collection, storage, transportation and inspection data of raw plasma; Second, Article 35 is added. Enterprises shall use information-based means to truthfully record all data formed in the production and inspection process to ensure that the whole production process continues to meet the legal requirements, based on the quality risk assessment, appropriate visual monitoring measures are taken for key production and inspection links. For manual operation (including manual operation, observation and recording, etc.) steps, the data formed by the process should be entered into the relevant information system or converted into electronic data in a timely manner to ensure that the relevant data is true, complete and traceable. In addition, it is clearly required that for Articles 25 and 35 of the Appendix, the enterprise shall meet the relevant requirements before January 1, 2027. New workshops or new production lines shall meet the requirements of Articles 25 and 25 of the Appendix.

Durst has been engaged in GMP compliance for many years and has accumulated a large amount of GMP compliance experience in the biological vaccine and blood products industry. He has provided GMP compliance services in Europe and the United States for many vaccine enterprises, biopharmaceutical enterprises and blood products pharmaceutical enterprises, coached enterprises to improve and improve GMP compliance, and coached pharmaceutical enterprises to pass on-site registration verification. The enterprises involved include: FDA, WHO, EU, PIC/S GMP projects of Proji Pharmaceuticals, Shuyang Pharmaceuticals, Sinopharm Biology, Anhui Longkema Biology, Zhaoyan Biology, Yisheng Biology, Kangtai Biology, Lizhu Biology, Chengdu Baiotek and other enterprises.