specification standard approved by SFDA.Р7405：生物制品国家标准品是否由国家药品检验机构统一制备、标化和分发。生产企业是否根据国家标准品制备其工作品标准。РWhether the bio-product national standard sample to be prepared, standardized and distributed from national drug inspection institute in unification. Whether the manufacturers formulate their standard working sample pursuant to the specification of national standard sample. Р7602：生物制品生产用物料是否对供应商进行评估并与之签订较固定合同，以确保其物料的质量和稳定性。РIs there assessment for the suppliers of the materials which to be applied in the bio-product manufacture, and to establish the fixed contract with those suppliers who have been approved, thus in this way to ensure the stable quality of materials? Р产品销售与收回 FINAL PRODUCT DISTRIBUTION & CALLBACKР投诉与不良反应报告РTHE REPORT ABOUT CLIENT COMPLAIN & NEGATIVE EFFECTР自检 SELF-INSPECTION
全文预览
