FDA工业指南：血液和血浆机构的生物制品偏差报告-2020终稿.pdf

Biological Product Deviation Reporting for Blood and Plasma Establishments Guidance for Industry This guidance is for immediate implementation. FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2) without initially seeking prior comment because the agency has determined that prior public participation is not feasible or appropriate. FDA invites comments on this guidance. Submit one set of either electronic or written comments on this guidance at any time. Submit electronic comments to . Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register . FDA will review any comments we receive and revise the guidance when appropriate. 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 March 2020 Table of Contents I. INTRODUCTION 1 II.