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【求助】应助 FDA警告信

专业英语

  • 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.
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  • 何当奇

    第1楼2009/07/24

    也没说不需要验证,只是要求比较低而已。但是也没说要做验证。还是要看药典上怎么写的

    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.

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  • 影子

    第2楼2009/07/24

    因为这些项目我们是都没有做验证的,所以迫切希望澄清一下。
    USP(1225)分析方法验证章节中只说药典方法需要做实际使用条件下的系统适用性测试,一般是针对GC、HPLC等测试的,这些项目是没法做的。

    redanqi 发表:也没说不需要验证,只是要求比较低而已。但是也没说要做验证。还是要看药典上怎么写的

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  • happyjyl

    第3楼2009/07/24

    个人理解:

    不需要validation,但需要verification。虽然二者在中文里都作“验证”讲,但在这里是不同的概念。validate的对象是准确性、精密度、线性等;verify的对象是适用性(suitability)。

    药典中收录的方法都是比较成熟的方法,所以不需要验证它的准确性、精密度等。但该方法在某一特定的试验条件下是否适用,这是需要验证的。所以ICH Q7A中规定:"the suitability of all testing methods used should'nonetheless be verified under actual conditions of use and documented."(所有检验方法都需要在实际试验条件下做验证并作记录。)

    相对于GC、HPLC等方法来说,干燥失重、炽灼残渣等属于比较简单的方法,因此对verification的需要较低,(there is a lesser need for verification for the simplest tests such as loss on drying, residue on ignition, and pH measurements.)但并非不需要。

    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。

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  • lingzhong

    第4楼2009/07/24

    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.

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  • 该帖子已被版主-何当奇加3积分,加2经验;加分理由:积极参与
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  • 影子

    第5楼2009/07/24

    暂时在Q7A中查到了validation的定义:
    A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria.
    为某一特定工艺、方法或系统能够持续产生符合既定接受标准的结果提供充分保证的文件程序。

    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。

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  • myreebok

    第6楼2009/07/27

    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。

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  • 影子

    第7楼2009/07/27

    那对于干燥失重来说,本地的适应性应如何做?

    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。

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  • 影子

    第8楼2009/07/27

    怪事!怎么今天才看到这个回复?我觉得这个回答很合理,多谢了!

    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.

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  • myreebok

    第9楼2009/07/30

    实际上,这又回到了设备OQ的阶段,你要证明的是,箱体能提供105(或其他个论规定的温度)的稳定输出。而不是样品的可以被干燥。

    但是,也有特例,比如,样品本身会产生热量的,这样的情况下,建议你参考IEC60086-2-2-2007中的检定方法

    hyheying 发表:那对于干燥失重来说,本地的适应性应如何做?

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  • 该帖子已被版主-何当奇加3积分,加2经验;加分理由:药典专家
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