CTD中 怎样写 JUSTIFICATION OF SPECIFICATION.pdf

CTD 中怎样写 JUSTIFICATION OF SPECIFICATION (质量标准合理性)的讨论 * 最 近 做 一 个 只 有 部 颁 标 准 的 产 品 的 CTD, 做 到 JUSTIFICATION OF SPECIFICATION 部分,狂晕啊,EP,USP 甚至 ChP 中都没有收载这个产品,这种情况 下,这一部分内容怎么做?请大家发表高见. 对于这种情况，一般来说，一方面你应当要和采用你们原产品作为原料的制剂厂 家联系，因为他们的质量标准应当要和他们的采购标准一致，而他们所制订的质 量标准必须是通过实验数据证明要能保证其制剂的质量。另一方面，你可以参考 相关的 ICH 指导原则。 Justification of Specification (S.4.5) 质量标准的合理性说明(第 S.4.5 章) Justification for the proposed drug substance specifications should be provided. The justification should be based on relevant development data (S.2.6), information on impurities (S.3.2), standards in an official compendium, batch analyses data (S.4.1), stability studies (S.7), toxicology data, and any other relevant data. The discussion in this section should unify data and information that are located in other sections of the application, either by reference or in summary. When justifying the specification, an applicant should consider data from (1) drug substance batches used in evaluating clinical efficacy and safety, bioavailability, and/or bioequivalence, (2) primary stability batches, and 1 (3) relevant development and process validation batches, when available. If multiple drug substance manufacturing sites or processes are planned, it can be valuable to consider data from these sites and processes in establishing the tests and acceptance criteria. This is particularly true when there is limited initial experience with the manufacture of the drug substance at any particular site or by any particular method. Justification for an in-process test that is used in lieu of a drug substance test should be included in S.2.4. 应当要提供拟定原料