查人人中国名人网信用管理师如何挂靠:帮忙翻译
来源：百度文库 编辑：查人人中国名人网 时间：2024/05/11 02:09:27
In all cases, does the significance of nonconformance and its impact on the critical quality attributes of the API or intermediate determine how much analytical data is sufficient to justify the reprocessing?
Are reprocessing operations subjected to appropriate evaluation to show that these steps consistently perform the expected functions and result in batches that comply with all established standards, specifications and characteristics?
Does reworking batches that do not conform to established standards or specifications by using processing steps that are different from the validated process involve extensive evaluation and documentation to show that the reworked product is of equivalent quality to that produced by the original process?
Are reprocessing operations subjected to appropriate evaluation to show that these steps consistently perform the expected functions and result in batches that comply with all established standards, specifications and characteristics?
Does reworking batches that do not conform to established standards or specifications by using processing steps that are different from the validated process involve extensive evaluation and documentation to show that the reworked product is of equivalent quality to that produced by the original process?
他们那些都不准，机器翻译的，一点技术含量都没有。
在所有的情况, 在美国石油协会的具决定性性质属性上做非顺应的重要性和它的冲击或者中间物决定分析的数据充份证明那再处理多少?
遵从所有的确定标准，规格和特性，正在再处理运作服从充用评估表示，这些阶段一致地运行预期的函数而且造成批?
重做藉由使用处理不同于被程序有效的阶段不遵照确定的标准或者规格的批包括广泛的评估和文件表示被重做的产品是有相等性质的到被最初程序生产?
在所有的情况, 在美国石油协会的具决定性性质属性上做非顺应的重要性和它的冲击或者中间物决定分析的数据充份证明那再处理多少?
遵从所有的确定标准，规格和特性，正在再处理运作服从充用评估表示，这些阶段一致地运行预期的函数而且造成批?
重做藉由使用处理不同于被程序有效的阶段不遵照确定的标准或者规格的批包括广泛的评估和文件表示被重做的产品是有相等性质的到被最初程序生产?
在所有案件, 不服从和它的对API 或中间体的重要质量属性的冲击的意义确定多少分析数据是充足辩解再加工?再加工操作被服从对适当的评估表示, 这些步一致地进行期望的作用和结果在遵照所有建立的标准的批, 规格和特征?整顿不依照建立的标准或规格由使用处理步骤是与被确认的过程不同的批介入广泛的评估和文献表示, 被整顿的产品是等效质量对那由原始的过程生产?
do it when I have time