原文由 hyheying 发表:
下面是FDA给一家制药生产厂家的警告信(WL),全文见下面的链接:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048332.htm
请看红色的这段话,对于药典中诸如干燥失重,炽灼残渣,pH等测试方法是否需要做验证?
We disagree with your assertions that verification is not required for those USP test methods used by your firm. In accordance with cGMP, analytical methods should be validated unless the methods used are included in a relevant pharmacopoeia or other recognized standard reference. If the method is a compendial method, verification of the methods should be conducted to determine that the method is suitable for its intended use under actual conditions. We acknowledge that the USP informational chapter <1226> suggests that there is a lesser need for verification for the simplest tests such as loss on drying, residue on ignition, and pH measurements. However, these do not include the test methods at issue, including the protein test method.
原文由 happyjyl 发表:
最好能查阅cGMP、ICH指导原则等文件中对validate和verify的精确定义。时间有限,这个任务就交给楼主啦。
原文由 lingzhong 发表:
个人认为这些简单的检测方法没有必要validation,即使verification也不需要,因为这种简单的方法你不可能只用于测一种产品(如果是,自求多福吧)。但是这两者什么都不做的前提,也是实验室的共有前提是:所用仪器都经过Qualification。
以下是1226结尾:
Verification is not required for basic compendial test procedures that are routinely performed unless there is an indication that the compendial procedure is not appropriate for the article under test. Examples of basic compendial procedures include, but are not limited to, loss on drying, residue on ignition, various wet chemical procedures such as acid value, and simple instrumental methods such as pH measurements. However, for the application of already established routine procedures to compendial articles tested for the first time, it is recommended that consideration be given to any new or different sample handling or solution preparation requirements.
原文由 hyheying 发表:原文由 myreebok 发表:
FDA永远不会嫌弃你做的多,但是作为工厂来说,该类限度鉴定的方法,最好做下本地的适应性即可,从文中来说,并没有明确表示不用做。
那对于干燥失重来说,本地的适应性应如何做?