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The manufacturing process of fermented new drugs is complicated, and the quality control is difficult. Referring to the relevant technical guidances of new drug chemistry, manufacturing, and control research, centering on the quality control characteristics of fermented new drugs, this article discusses the general considerations on the manufacturing process, elucidation of structure, specification research, to provide a reference for the research of fermented new drugs.

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微生物发酵来源化学创新药的生产工艺复杂，质量控制难度较大。本文参考国内外已发布的化学药品药学研究技术要求，围绕微生物发酵来源化学创新药的质量控制特点，探讨该类药物生产工艺、结构确证、质量标准等研究的一般考虑，为该类药物的研究提供参考。

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赵一飞，男，审评员，主要从事药品技术审评工作。联系电话：(010)85242796，E-mail: zhaoyf@cde.org.cn。

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赵一飞，男，审评员，主要从事药品技术审评工作。联系电话：(010)85242796，E-mail: zhaoyf@cde.org.cn。

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