数据完整性管理从哪里开始

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23. Where does my company’s responsibility begin andend in relation to data integrity aspects of the supply chain for medicinalproducts?

All actors in the supply chainplay an important part in overall data integrity and assurance of productquality.

Data governance systems should be implemented from the manufacture ofstarting materials right through to the delivery of medicinal products topersons authorised or entitled to supply medicinal products to the public.

Relative responsibilities and boundaries should be documented in thecontracts between the relevant parties. Final responsibility of ensuringcompliance throughout the supply chain rests with batch certifying QP.

各位蒲友：

上面的一句话适合于API生产吗？？

针对于一个API厂家，其有生产原料药起始物料之前的化合物，那么这些化合物的检测是否可以在研发技术部门进行，而不在QC部门进行检测，从而至少在实验室数据方面，不参与到相应的数据完整性管理过程中，或至少不会像GMP产品那样严格要求？？但是在其他方面，比如生产，仓储等等方面却存在由于设备设施的共用，物料的共用却无法彻底分离，不知道大家如何对这些化合物进行管理的呢？？谢谢！

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