美国FDA 指导原则 传染病病毒疫苗生产中使用的细胞底物和其他生物材料的特性和鉴定工业指南 英文原版.pdfVIP

Guidance for Industry Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD) (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852­ 1448, or by calling 1-800-835-4709 or 301-827-1800, or email ocod@, or from the Internet at /BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/G