分段生产

lumang

各位专家请教个问题：FDA 指南Cooperative Manufacturing Arrangements for Licensed Biologics中有三个定义：1、Divided manufacturing is an arrangement in which two or more manufacturers, each registered with FDA in accordance with 21 CFR Parts 207, 607, or 807 as applicable, and licensed to manufacture a specific biological product in its entirety, participate jointly in the manufacture of that product.
2、Shared manufacturing is an arrangement in which two or more manufacturers are licensed and responsible for specific aspects of the manufacture of a product but none is licensed for all aspects of the manufacture of the product.
3、For the purposes of this document, contract manufacturing refers to a situation in which a license manufacturer establishes a contract with another entity(ies) to perform some or all of the manufacture of a product as a service to the license manufacturer. This includes, for example, required infectious disease testing of blood and blood components conducted by licensed blood establishments for another manufacturer.

烦请熟悉FDA法规的同行解释下这三者具体有何区别，我国实施条例（征求意见稿）中分段生产属于哪类？