21 CFR 314.50CMC及样品标签.docx

21 CFR 314.50 申请的内容和格式d Technical sections技术部分（1）Chemistry, manufacturing, and controls section CMC部分(i)Drug substance. A full description of the drug substance including its physical and chemical characteristics and stability; the name and address of its manufacturer; the method of synthesis (or isolation) and purification of the drug substance; the process controls used during manufacture and packaging; and the specifications necessary to ensure the identity, strength, quality, and purity of the drug substance and the bioavailability of the drug products made from the substance, including, for example, tests, analytical procedures, and acceptance criteria relating to stability, sterility, particle size, and crystalline form. The application may provide additionally for the use of alternatives to meet any of these requirements, including alternative sources, process controls, and analytical procedures. Reference to the current edition of the U.S. Pharmacopeia and the National Formulary may satisfy relevant requirements in this paragraph.原料药的完整描述，包括理化性质和稳定性，制造商的名称和地址，原料药的合成（或分离）以及纯化方法，生产和包装的过程控制，必要的规范以确保原料药的一致性、含量、质量和纯度以及由这些原料制成的药物制剂的生物利用度，包括测试、分析方法和与稳定性、无菌控制、粒度和结晶形态相关的验收标准。为符合要求，申请中可能会提供额外的替代方法，包括替代的能源、过程控制和分析方法。参照美国药典和国家处方集的当前版本，以满足本章节的有关规定。(ii)(a)Drug product . A list of all components used in the manufacture of the drug product (regardless of whether they appear in the drug product) and a statement of the composition of the drug product; the specifications for each component; the name and address of each manufacturer of the drug product; a description of the manufacturing and packaging procedures and in-process controls for the drug product; the specifications necessary to ensure the identity, strength, quality, purity, potency, and bioavailability of the drug product, including, for example, tests, analytical procedures, and acceptance criteria relating to sterility, dissolution rate, container closure systems; and stability data with proposed expiration dating