药品召回是指药品生产企业按照规定的程序收回已上市销售的存在安全隐患的药品。在cGMP以下问答指南中,FDA对于药品召回的相关要求,以问题解答的方式给予了详细的说明。
问1:什么是召回?
答:
§211.150分销程序
Q1. What is a recall?
A:
问2:FDA可以强制召回人药吗?
答:
Q2. Can FDA mandate a recall of human drugs?
A:
问3:非处方药是否与处方药一样,受召回规定的约束?
答:
Q3. Are over-the-counter (OTC) drugs subject to the same recall provisions as prescription drugs?
A:
问4:FDA是否期望企业对已放行和拒绝的批次进行调查,以发现潜在的召回需求?
答:
Q4. Does FDA expect firms to investigate both released and rejected lots for potential recalls?
A:
问5:如果公司不自愿召回有缺陷的产品怎么办?
答:
Q5. What happens if a firm does not voluntarily recall a defective product?
A: