美国FDA 指导原则 血液机构使用病原体减量装置制造血液成分工业问答指南 英文原版.pdfVIP

Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers Guidance for Industry Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@, or from the Internet at /vaccines-blood-biologics/guidance-compliance- regulatory-information-biologics/biologics-guidances. For questions on the content of this guidance, contact OCOD at the phone numbers or email address listed above. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research November 2021 Contains Nonbinding Recommendations Table of Contents I. INTRODUCTION 1 II. QUESTIONS AND ANSWERS 2 A. General Information 2 B. Manufacture of Pathogen-Reduced Blood Components by Blood Establishments 3 C. Reporting Implementation of Pathogen Reduction in Licensed Blood Establishments 6 III. REFERENCES 10 APPENDIX 11 i Contains Nonbinding Recommendations Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers Guidance for Industry This guidance represents t