USP和国内的方法验证转移的要求也是一致的,对比的是转出方和接收方两个实验室检测的对比
USP <1224> Testing to the specification of an ancillary material, intermediate, and/or ingredient and product is critical in establishing the quality of a finished dosage form. The transfer of analytical procedures (TAP), also referred to as method transfer, is the documented process that qualifies a laboratory (the receiving unit) to use an analytical test procedure that originated in another laboratory (the transferring unit, also referred to as the sending unit), thus ensuring that the receiving unit has the procedural knowledge and ability to perform the transferred analytical procedure as intended.
对辅料、中间体、和/或药物成分和产品进行检验确定是否符合质量标准对确定制剂成品的质量是非常重要的。分析方法转移程序(TAP),通常也称作方法转移,该程序就是记录一个实验室(接收方)能够使用由另一个实验室(转移方,也称作转出方)所开发检验方法的过程,并确保接收的实验室知道检验的程序并有能力按规定进行检验。
分析方法验证我更多还是建议接收方来做更好,理由如下:
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