samples of its software. Part six discusses the applying of SPIN to significant issues. Appendices A
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建立有据可循的 书面协议（created protocols）和 预期结果（expected results）对于工艺确认非常重要。书面协议应包括 生产条件（producing situations）、 数据收集（knowledge collections）、 测试（testings）和 取样计划（sampling options）。
2. Water system validation is required so that you can study the reproducibility, regularity & performance of water system.
Compile and evaluate all test features and validate the resolution of any discrepancies or deviations. Efficiency Qualification of Period-one is acceptable when all problems specified are fulfilled.
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issue, or in general any expression that's used as a press release, is just executable if it evaluates to a
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In the current methodology (by TOC or By HPLC) of analysis of residue written content, there will always be some residue received in outcome.
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Swab samples shall be taken after the final cleaning on the equipment and after the equipment qualifies to the visual inspection test. The sampling course of action ought to be defined during the protocol.
Process website Validation Protocol is described to be a documented approach for screening a pharmaceutical products and process to confirm which the generation process accustomed to manufacture the solution performs as supposed.
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