630 对血液、血液组分和血液衍生物的一般要求 GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES 640 对人类血液和血液制品的附加标准 ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS 660 对用于实验室检测的诊断物质的附加标准 ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR ...
630 对血液、血液组分和血液衍生物的一般要求 GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES 640 对人类血液和血液制品的附加标准 ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS 660 对用于实验室检测的诊断物质的附加标准 ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR ...
美国FDA 指导原则 使用ISBT 128统一标识血液和血液成分的美国行业共识标准 英文原版.pdf,United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 Version 3.0.0 March 2013 Tracking Number ICCBBA IG-002 Pub
A brief description of the methods you used to test for infectious agents, and methods you used to inactivate these reagents. When blood products are used, you should include a certification statement that the animal/human source components or any blood product derived material used in the QC ...
biological products in BLAs under the PHS Act, FDA has, as a scientific matter, generally not 3 For CDER, see /drugs/forms-submission-requirements/drug-master-files-dmfs; for CBER, see /vaccines-blood-biologics/new-drug-application-nda-process-cber/drug-master-files-cber- regulated-products. ...
https: //www.ich.org/page/efficacy-guidelines. [6] FDA. In Vitro Companion Diagnostic Devices [EB/OL]. (2014-08-06)[2022-12-16]. https://www.fda.gov/vaccines- blood-biologics/guidance-compliance-regulatory-infor mation-biologics/biologics-guidances. [7] FDA. Adaptive Design Clinical ...
FDA BLOOD BANK INSPECTION GUIDE; AN IDEA OF BLOOD BANK INSPECTION ISSUES, LINKS TO BLOOD INFORMATION.
Water 水 Water used in the manufacture of APIs should be demonstrated to be suitable for its intended use. 原料药生产中使用的水应当证明适合于其预定的用途。 Unless otherwise justified, process water should, at a minimum, meet World Health Organization (WHO) guidelines for drinking (portable) ...
Guidance for Industry Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) FDA is issuing this guidance for immediate implementation in accordance ...
Center for Biologics Evaluation and Research (CBER) regulates biologics such as blood products, tissue products and vaccines. Center for Devices and Radiological Health (CDRH) Center for Devices and Radiological Health (CDRH) regulates medical devices such as knee andhip implantsand radiation-emitting ...