要对检验方法的原始验证进行审核，以保证符合现行ICH/VICH要求。要进行差距分析，并记录以识别在进行技术转移过程前，是否需要进行补充验证。 6.39 The transfer of testing methods from one laboratory (transferring laboratory) to
another laboratory (receiving laboratory) should be described in a detailed protocol. 应制订一个详细的方案说明如何将检验方法从一个化验室（转出化验室）转移至另一个化验室（接收化验室）。
6.40 The transfer protocol should include, but not be limited to, the following parameters:
转移方案应包括，但不仅限于，以下参数
i. Identification of the testing to be performed and the relevant test method(s)
undergoing transfer;
识别要进行的检测项目和相关的需要转移的检验方法； ii. Identification of the additional training requirements; 识别新增的培训要求；
iii. Identification of standards and samples to be tested; 识别要测试的标准和样品；
iv. Identification of any special transport and storage conditions of test items; 识别检测项目是否有特殊运输和存贮条件；
v. The acceptance criteria which should be based upon the current validation study of
the methodology and with respect to ICH/VICH requirements.
基于现行的方法学验证研究以及ICH/VICH要求制订的可接受标准。
6.41 Deviations from the protocol should be investigated prior to closure of the technical
transfer process. The technical transfer report should document the comparative outcome of the process and should identify areas requiring further test method revalidation, if applicable.
与方案不符的偏差在技术转移过程完成前要进行调查。技术转移报告应记录转移过程中的对比结果，必要时，应指出需要进一步验证的方面。
6.42 Where appropriate, specific requirements described in others European Guidelines,
should be addressed for the transfer of particular testing methods (e.g Near Infrared Spectroscopy).
适当时，特殊的检测方法（例如近红外光谱）的转移中应指明其它欧洲指南中的 要求。．
EU GMP第六章节质量控制 quality control 翻译
