美国药典检验方法确认.docx

Verification ：确认。针对使用法定方法 (注意: 需要严格遵守方法要求， 参数, 试剂, 标准品, 步骤等等 ), 需 要在目前实验室的条件下确认是否可以获得可靠结果 . 不一定是全部项目的验证， FDA 针对常州 SPL 肝素 钠的警告信中就有关于方法确认的内容 . 可以参考。 1226 VERIFICATION OF COMPENDIAL PROCEDURES药典规程的确认 The intent of this chapter is to provide general information on the verification of compendialprocedures that are being performed for the first time to yield acceptable results utilizing the personnel,equipment, and reagents available. This chapter is not intended for retroactive application to alreadysuccessfully established laboratory procedures. The chapter Validation of Compendial Procedures