Appropriate qualification of API Starting Material suppliers is required.
起始物料的供应商应具备适当的资质。
The company should document the rationale for the designated API starting material.
公司必须记录定义某个起始原料的原理和理由。
Where in a given process the designated regulatory API starting material comes will vary with each process.
从已知工艺中确认API生产的起始物料因工艺不同而不同。
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