FDA prohibits sampling and testing with the goal of achieving a specific result or to overcome an unacceptable result (e.g., testing different samples until the desired passing result is obtained). This practice, also referred to as testing into compliance, is not consistent with CGMP (see the guidance for industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production). In some situations, use of actual samples to perform system suitability testing has been used as a means of testing into compliance. FDA considers it a violative practice to use an actual sample in test, prep, or equilibration runs as a means of disguising testing into compliance.

FDA禁止为实现特定结果或避免不可接受的结果而进行取样和测试（例如检测不同的样品直到获得满意的结果）。这种做法，也被称为检测至合格（testing into compliance），是不符合CGMP的（参考《对药品生产中出现超标（OOS）检验结果进行调查的行业指南》）。在某些情况下，使用实际样品来进行系统适用性测试已被作为检测至合格的一种方式。FDA认为在测试、预运行或平衡运行中使用实际样品作为掩盖检测至合格的手段是一种违规行为。

According to the United States Pharmacopeia (USP), system suitability tests must include replicate injections of a standard preparation or other standard solutions to determine if requirements for precision are satisfied (see USP General Chapter <621> Chromatography). System suitability tests should be performed according to the firm’s established written procedures—which should include the identity of the preparation to be injected and the rationale for its selection—and the approved application or applicable compendial monograph (§§ 211.160 and 212.60).

根据美国药典的要求，系统适用性测试必须进行标准试剂或其他标准溶液的重复进样，以确定是否满足精密度要求（参见美国药典通则<621>色谱法）。系统适用性测试应根据公司的既定书面程序- 应包括待进样溶液的鉴别和选择依据—和已批准的申请或适用的药典专论来进行。（§§ 211.160 和 212.60）

If an actual sample is to be used for system suitability testing, it should be a properly characterized secondary standard, written procedures should be established and followed, and the sample should be from a different batch than the sample(s) being tested (§§ 211.160, 211.165, and 212.60). CGMP original records must be complete (e.g., §§ 211.68(b), 211.188, 211.194) and subjected to adequate review (§§ 211.68(b), 211.186(a), 211.192, and 211.194(a)(8)). Transparency is necessary. All data—including obvious errors and failing, passing, and suspect data—must be in the CGMP records that are retained and subject to review and oversight. An investigation with documented, scientifically sound justification is necessary for data to be invalidated and not used in determining conformance to specification for a batch (see §§ 211.160, 211.165, 211.188, and 211.192).

如果在系统适用性测试中使用实际样品，实际样品应当是经过适当鉴定的工作标准品，应建立并遵守书面规程，样品应来自于与待检样品不同的批次。（§§211.160，211.165，和212.60）。CGMP原始记录必须完整（例如，§§211.68（b），211.188,211.194）并进行适当的审核（§§211.68（b），211.186（a），211.192和211.194（a）（8））。透明度是必要的。所有数据（包括明显错误以及不合格，合格和可疑数据）必须存在于保留的CGMP记录中，并且需要进行审核和监督。对于无效并且不用于判定批是否符合质量标准的数据，必须进行科学充分的证明的调查并进行记录（参见§§211.160,211.165,211.188和211.192）。



For more information, see the ICH guidance for industry Q2(R1) Validation of Analytical Procedures: Text and Methodology and VICH guidances for industry GL1 Validation of Analytical Procedures: Definition and Terminology and GL2 Validation of Analytical Procedures: Methodology.15

更多信息参见ICH行业指南Q2（R1）分析程序验证：文本和方法，VICH工业指南GL1分析程序的验证：分析程序的定义和术语，及GL2验证：方法。



VICH=Veterinary International Conference on Harmonisation.

VICH=兽医国际协调会。