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本文根据对新药申报的化学药品制剂CTD格式申报资料撰写要求相关内容的理解,结合审评工作体会,针对制剂处方工艺的申报资料进行解读和分析。CTD格式申报资料技术评价的核心是通过对原辅料质量控制、处方研究、关键生产环节研究及有效过程控制、工艺放大研究验证,证明能够建立完整的生产过程质量控制体系,持续稳定生产出符合设计质量要求的药品。
According to the comprehension of the related content of the application form for the declaration of the new chemical drug formulation CTD and the experience of the review work, this paper will analyze and interpret the application data of the formulation prescription technology. The core of technical evaluation of CTD format declaration data is through the quality control of raw materials, prescription research, key production links and effective process control, process amplification research and verification, to prove that a complete production process quality control system can be established, consistent and stable production to meet the design Quality requirements of the drug.