起始物料的供应商应具备适当的资质。
Appropriate qualification of API Starting Material suppliers is required.
在供应起始物料的合同中，应确定变更控制的有关要求。
Similarly, Change Control requirements should be defined in the commercial contract for supply of API Starting Materials.
一般来说，物料的来源不是考虑是否是起始物料的主要因素。
In general, the source of the API Starting Materials is not the major factor.
从已知工艺中确认API生产的起始物料因工艺不同而不同。
Where in a given process the designated regulatory API starting material comes will vary with each process.
技术部门、质量部门要和法规部门紧密合作，以形成大家一致认可的起始物料。
The technical and quality groups should work closely with regulatory groups to ensure no disagreement occurs on the proposed starting materials.
审核官员可能会同意你或是不同意你，也可能认为起始物料在工艺更后面的步骤。
The reviewers are either going to agree with you or disagree, and they might think that it's further back in the process.
起始物料的生产商/供应商检验报告应有负责人签名，其应具备适当的资质和经验。
The certificate of analysis of the manufacturer/supplier of the starting material should be signed by a designated person with appropriate qualifications and experience.
当你开发一条新的化学工艺或是API生产工艺的时候，你最好和药政审核部门讨论你的起始物料选择。
When you're developing a new chemical process or API process you should be discussing your choice of API starting material with the review division.
生物负载可能存在于原料、原料药的起始物料、中间体或原料药中的微生物的水平和种类(例如，致病的或不致病的)。
Bioburden The level and type (e. g. objectionable or not) of micro-organisms that can be present in raw materials, API starting materials, intermediates or APIs.
该章声明了如果你已经知道不会有溶剂出现，则不需要进行测试。但是，谨慎的做法还是要评估你的起始物料和最终成品。
The chapter states that no testing is required if you know that solvents are not present. However, it is always prudent to evaluate your starting materials and finished product.
回答：本章节已声明，若（生产商）确定产品不存在有机溶剂，则不需任何残留溶剂测试，然而，谨慎的做法是评估起始物料和最终产品。
The chapter states that no testing is required if you know that solvents are not present. However, it is always prudent to evaluate your starting materials and finished product.
草案给了一个例子说明文件的内容，其中提到，上述内容以外，批准供应商的质量标准，（起始）物料的帐单。
Then examples are given for the content of such documents. Mentionedare, inter alia, specification of approved suppliers but also bills of(starting) materials.
草案给了一个例子说明文件的内容，其中提到，上述内容以外，批准供应商的质量标准，（起始）物料的帐单。
Then examples are given for the content of such documents. Mentionedare, inter alia, specification of approved suppliers but also bills of(starting) materials.
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