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法规和指南
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产品相关研究
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工艺研究
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质量研究
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可比性研究
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QTTP→CQA→CPP→工艺描述→工艺风险评估→工艺验证风险评估（关联工艺控制策略在里面）→工艺验证→制造检定风险评估→工艺规程
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工艺验证策略
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单元
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连续
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规模
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中间产品挑战时限
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需研究、确证的内容
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参数范围应经过工艺验证进行全面研究确证
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