POST NDA APPROVAL 后期NDA批准 After approval and marketing of a pharmaceutical product, significant changes may be made in manufacturing the bulk drug substance. There may be technological, ecological, economic, or safety reasons for these changes. If they occur, the Pharmacopeial and NDA impurity limits and rationale should be reviewed; the limits should be revised when indicated to ensure similar or improved quality of the drug substance. 药物制剂的批准和销售之后，生产散装的原料药方面可能会发生大的改变。这些变化可能是工艺上的、生态学上的、经济上的或出于安全原因。如果发生变化，应检查药典和NDA杂质限定和原理；为确保原料药的相似或改善质量时，应修改限度。
ANDA FILING ANDA文件编写 The drug substance for a pharmaceutical product eligible for ANDA status normally is an official article and should be well characterized analytically. Drug substances are typically available from multiple sources, and each source may have a different manufacturing process. Therefore, it is essential that the dosage-form manufacturer evaluate each supplier's drug substance impurity profiles. Limits can then be set based on the more detailed concepts described for NDA filing, including review of compendial monographs for appropriateness. 符合ANDA状态的制剂的原料药通常是法定的药品并应很好的分析其特点。原料药可以从多个途径获得，并且每种途径可以有不同的生产过程。因此，剂型生产商评估每个供应商原料药的杂质情况是相当重要的。可根据NDA文件中描述的更为详尽的概念来制订限度，包括药典正文适当性的检查。
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