《QA7问答》.docVIP

Section 1A: Background and History Q: Based on FDA changing of the meaning of should, does this mean that Q7A will be applied differently in the US than in the EU? 基于FDA改变了“should”的意思，那是否意味着Q7A在美国的应用与欧盟将不一样？ No. The change was made by FDAs attorneys to comply with Good Guidance Practices. There was no change in meaning intended. The change in the definition of should, was not intended to have any impact on how the guidance is applied either domestically or abroad. Remember, Q7A is a guidance document, but it is not legally binding to either the FDA or the public. 不是。这是FDA的律师为了符合优良指导规范而做的改变。意思上没有变化。它对本指导原则在国内或国外的应用没有任何影响。记住，Q7A是一个指导文件，它对FDA或公众都没有法律的约束。 Q: How do you define a significant structural element in an API starting material? 你如何定义API起始物料的“主要结构元素”？ A significant structural fragment is that portion of a molecule that contributes to or is responsible for the molecules pharmacological activity. The original definition talked about an important element. In Q7A the term element, was changed to fragment to avoid confusion with the chemical understanding of element. 主要结构片段是分子中贡献或负责分子药理活性的一部分。最初的定义是一个重要的元素。在Q7A中，为了避免与化学上的元素混淆，“元素”被换成“片段”。 Q: How close can you get to the API and still call it an API starting material? API起始物料和API可以有多近？ The company should document the rationale for the designated API starting material. Where in a given process the designated regulatory API starting material comes will vary with each process. One of the difficulties was trying to cover all possible situations, because thats nearly impossible. The decision to designate an API starting material is based on more than chemical logic. It is a pharmaceutical consideration as well. Remember, there is a patient at the very end of every API process who is suffering from a disease, and the goal to provide something to get rid of his illness in a safe and reliable manner. 公司应该证明指定API起始物料的合理性。在一个特定的工艺过程中，特定的API起始物料在每一步都会变化。难点之一就是试图覆盖所有的可能情况，这几乎是不可能的。指定API起始物料不仅要基于化学逻辑，它也是一个制药学上考虑的问题。记住，每一个API过程的终