Although there is no binding regulation on European level, there seem to be some countries that force to have such an agreement. For instance, France is requiring a Quality Agreement between the API/ excipient manufacturer and the pharmaceutical manufacturer in case the incoming testing for the raw materials shall be delegated to the API/ excipient manufacturer according to French law.
居然在某些情况下,制剂方可将采购的原辅料来料委托原辅料生产企业进行来料检验????这种方式是否可采用???