05
2024-07
Supplier audit, colleagues need not worry, have reference
Supplier Management As part of the daily work of QA, materials are subject to strict qualification and on-site review before they are identified as qualified suppliers. As required by China GMP(2010 Edition), Chapter 10 (Quality Control and Quality Assurance), Section 7 (Evaluation and Approval of Suppliers) and Appendix (Computerized Systems):
2024-07-05
05
2024-07
Recently, the team of experts from Dust went to Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. and successfully launched the "Chongqing Zhixiang Jintai Bio-EU GMP QP Project" kick-off meeting.
2024-07-05
05
2024-07
State Food and Drug Administration: Blood Products Appendix (No. 70 of 2024)
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.
2024-07-05
Contact Information
Durst (Shenzhen) Consulting Service Co., Ltd.
Contact Phone:86-18826007039
E-mail:consulting@delsalt.com
Address: C19, Building 1, Yongheyuan, Zhuangbian Community, xixiang street, Bao 'an District, Shenzhen City, Guangdong Province
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