钠注射液、注射用水等原则上不纳入一致性评价范围，但其灭菌工艺、滤器与包材选择（含相容性研究）等应符合相关技术要求。
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15、Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: ANDA Submissions – Refuse to Receive for Lack of Justification of Impurity Limits. August 2016
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DrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm142112.htm
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为更好地服务申请人开展化学药物注射剂一致性评价工作，总局一致性评价办公室将组织对上述参考文献进行翻译，及时在药品审评中心网站公开。
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