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发表于 2019-4-25 15:02:29
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这种问题,我建议直接查询法规。比如PDA TR60的1.1节目的和范围中就明确写了如下内容:
the PV lifecycle concept links product and process development, the qualification of the commercial manufacturing processes, and maintenance of the commercial production process in a coordinated effort. When based on sound process understanding and used with quality risk management priceipals, the lifecycle approach allows manufactures to use continuous process verification(enhanced approach) in addition to, or instead if , traditional PV.
意思就是使用生命周期法,可直接使用CPV模式 |
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