工作标准品应基于一级标准品进行标定并保证追溯性，商业化生产阶段，委托外部机构开展工作对照品的标化/复标可行，需签订质量协议及委托协议，保证标定结果的准确性和可追溯性及数据的完整性。

建议： 巴西注册审评时，对于方法验证一般不认可工作标准品，建议使用法定标准品（可得）

GMP中关于工作标准品的使用记要求如下：

1、中国GMP2010版 第十章质量控制

三）企业如需自制工作标准品或对照品，应当建立工作标准品或对照品的质量标准以及制备、鉴别、检验、批准和贮存的操作规程，每批工作标准品或对照品应当用法定标准品或对照品进行标化，并确定有效期，还应当通过定期标化证明工作标准品或对照品的效价或含量在有效期内保持稳定。标化的过程和结果应当有相应的记录

2、EU GMP Chapter 6 Quality Control

6.20 Reference standards should be established as suitable for their intended use. Their qualification and certification as such should be clearly stated and documented. Whenever compendial reference standards from an officially recognised source exist, these should preferably be used as primary reference standards unless fully justified (the use of secondary standards is permitted once their traceability to primary standards has been demonstrated and is documented). These compendial materials should be used for the purpose described in the appropiate monograph unless otherwise authorised by the National Competent Authority.

3、WHO GMP

14.40 Secondary or working standards may be established by the application of appropriate tests and checks at regular intervals to ensure standardization.

14.42 All in-house reference standards should be standardized against an official reference standard, when available, initially and at regular intervals thereafter.