Raw material-WCBPCMC09KhanSlides 生物制药 原物料管理.pdfVIP

CASS CMC Strategy Forum : January 11, 2009 CBER’s Perspective on Regulating Raw Materials in Biologics Arifa S. Khan, PhD Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration 1 Topic Covered CBER products Risks of adventitious agent contamination Qualification and management of raw materials Case study and control Regulatory Guidance documents