药典检验与监管指南
药物赞助人和申请人在申请中应提供辅料、原料药和成品药的标准（即属性、分析程序和合格指标）。这些标准应符合美国药典/国家处方(USP/NF)、英国药典(BP)、欧洲药典(EP)或日本药典(JP)的质量标准。药典检验是许多原料药和成品药的标准检测方案。进行检验并符合药典方法所述标准，是原料药和成品药在全球生产、放行和发运的基本要求。
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