| 查看: 677 | 回复: 0 | ||
zhangy_1977铜虫 (小有名气)
|
[求助]
FDA缺陷信中的对照品一致性
|
|
最近看到一个FDA的缺陷信问题，如下。 OBSERVATION 4 Laboratory controls do not include the establishment of scientijfically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. Specifically, during the establishment o f system suitability for chromatographic analyses, the firm did not prepare or use a second working standard solution (Check Standard Solution) to confirm the potency, accuracy and purity of the working standard solutions (Primary Standard Solution). A single standard preparation was used to determine the potency, accuracy and purity of the active pharmaceutical ingredient in the sample solution. 问下大神，这个怎么做，是用一个对照品，配成两个对照溶液，进行比较？还是用两个对照品分别配成两个对照溶液进行比较啊？第一个对照与第二个对照溶液如何计算比较？ |
回复此楼» 猜你喜欢
应该是93bebmhtak前后十一个字符比较关键
已经有13人回复
-
关于代码变化问题，想知道的进来
已经有20人回复
-
这样的filecode谁见过
已经有21人回复
-
filecode与中标关系的预测
已经有5人回复
-
fileCode有新解读？
已经有18人回复
-
关于filecode，很负责任的告诉大家
已经有7人回复
-
【2027博士申请】纳米药物递送方向
已经有5人回复
-
关于豆爷回答的JTJC与%2F数量
已经有7人回复
-
2026国自然放榜时间
已经有3人回复
-
国基金的申报应该改成非等额制，评价高的钱多评价低的钱少，但是增加资助率
已经有7人回复
20