Jiachang Biological - biotechnology services and research and development as one of the high-tech enterprises
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2、法规依据
"Viral Safety Control of Biologics" (General Requirements, Part III, Pharmacopoeia of the People's Republic of China, 2020 Edition)
"Guidelines on Technical Methods and Validation for Viral Inactivation/Removal in Blood Products" (State Food and Drug Administration Announcement [2002] No. 160)
"General Technical Review Guidelines for Viral Safety Evaluation of Biological Tissue Extracts and Eukaryotic Cell-Expressed Products" (State Food and Drug Administration, [S]GPH3-1, December 2005)
"Guidelines for Validation of Viral Inactivation/Removal Effectiveness in Animal-Derived Medical Devices" (Announcement on the Issuance of Technical Review Guidelines for Registration of Animal-Derived Medical Devices, CFDA Announcement [2017] No. 224)
Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin. 1999. ICH Q5A（R1）
Design, Evaluation, and Characterization of Viral Clearance Procedure.2016. USP General Chapter: <1050.1>
