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建立有据可循的 书面协议（prepared protocols）和 预期结果（expected outcomes）对于工艺确认非常重要。书面协议应包括 生产条件（producing circumstances）、 数据收集（data collections）、 测试（testings）和 取样计划（sampling options）。
If your goal of protocol design is usually summed up into a person phrase it should be that the designer has the diffi-
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Deliver rigorous tests to display the check here efficiency and reproducibility of the full integrated process.
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Process Validation Protocol is described being a documented prepare for testing a pharmaceutical solution and process to substantiate that the production process utilized to manufacture the product or service performs as meant.
five. Validation is a whole documented evidence which supplies the surety that any specified process persistently provides the top product or service getting predetermined quality parameters and requirements.