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In a citation for Wockhardt in the November 2013 warning letter17 for using
test injections there is the following:
Neither the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH)
document Q2R1, “Validation of Analytical Procedure: Text and Methodology,”
nor the United States Pharmacopoeia General Chapter <1058>, “Analytical
Instrument Qualification,” includes instructions for performing
“trial” injections for a method that is validated.
This is an interesting citation and rationale, examining these two references
in more detail we find:
●● ICH Q2(R1)41 outlines the experiments for validation of an analytical
procedure. In Section 9 there is a single paragraph that outlines the use
of system suitability tests (SSTs) for checking that the whole analytical
system is suitable for conducting an analysis and cross references the
pharmacopoeias for more information.
●● United States Pharmacopoeia general chapter <1058>42 is focused on
analytical instrument qualification (AIQ). It is not surprising that it does
not mention an operational detail about the test injections as it is not
within the scope of the general chapter! Therefore, the citation of this
reference as justification for not permitting “test” injections is plainly
wrong and spurious.
In my view the Agency would be on much better ground if they cited USP
<621> on chromatography43 or even 211.160(a)29 for scientific soundness.
在2013年11月关于Wockhardt使用试针的警告信中【17】，对其引用如下: 无论ICH文件Q2R1“分析程序的验证:文本和方法学”或美国药典总章1058“分析仪器的确认”都没有包括对一种已被验证的方法进行“试验”注射的说明。 这是一个有趣的引用和基本道理，在更详细地检查这两个参考文献时，我们发现: ICH Q2(R1)【41】概述了用于验证分析方法的实验。在第9节中有一个单独的段落概述了使用系统适用性试验(SSTs)检查整个分析系统是否适合进行分析和交叉引用药典以获得更多信息。 ●美国药典总章<1058>【42】侧重于分析仪器确认(AIQ)。这并不奇怪，它没有提到关于测试注入（试针）的操作细节，因为它不在通用章的范围内!因此，引用这一条款作为不允许“试验”注射的理由显然是错误的。 在我看来，如果他们引用USP<621>色谱法【43】甚至211.160(a)【29】反而更科学可靠。
这个老先生真勇敢，给检察员的不当引证挑毛病。
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发表于 2020-10-30 10:57:46
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