杭州交通信息网如何增加水泥强度:帮忙翻译，不要是机器翻译的。
来源：百度文库 编辑：杭州交通信息网 时间：2024/04/28 13:44:23
13.2.10 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?
13.2.2 If it becomes necessary to more than occasionally reprocess batches by physical manipulation, is a thorough investigation conducted and documented to determine the adequacy of the original process?
13.2.3 Is appropriate action taken to minimise the risk of recurrence (e.g. if investigation of the nonconformance and/or review of the process reveals an abnormally high rate of batches that need to be recrystallised, it would be reasonable to incorporate the recrystallization as part of the normal process)?
我是家制药企业的，这是欧洲药品GMP认证的有关内容，大家都不容易，我都被折磨八十多页了。
再试试看!!
13.2.9 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?
在所有情况下,这种显著差异性以及其对API或中间产物的关键性品质属性的影响能决定需要多少分析数据来验证再处理(或调制)过程的正确可行性呢?
13.2.10 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?
再处理(或加工)是否经过了合理评估并表现出这些步骤能持续发挥其预期功能,并产出与已有标准,规格说明和特点相符合的批量产品呢?
13.2.2 If it becomes necessary to more than occasionally reprocess batches by physical manipulation, is a thorough investigation conducted and documented to determine the adequacy of the original process?
如果不是用物理操作方式偶尔再处理(或调制)批量产品,而是成为自然必要的话.是否已进行的有文件记录的全面调查能决定原处理调制程序的恰当性?
13.2.3Is appropriate action taken to minimise the risk of recurrence (e.g. if investigation of the nonconformance and/or review of the process reveals an abnormally high rate of batches that need to be recrystallised, it would be reasonable to incorporate the recrystallization as part of the normal process)?
是否已采取合适的行动来减低重复发生的风险了呢?(例如,如果这种差异性的调查和或处理加工程序显示批量产品需要重结晶的比率反常的高的话,那么将重结晶过程与正常处理程序相结合并成为其中一部分就是合理可行的).
13.2.9 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?
在所有情况下，API及中间体的不合要求/标准的重要性及对关键的质量属性的影响是否足以证明重新制作是正当的/必须的？
13.2.10 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?
重制作操作是否有经过合适的评估来显示这些步骤一贯如期待的运行， 生产出一批批的合乎所有已制定的规格， 指标及特性？
13.2.2 If it becomes necessary to more than occasionally reprocess batches by physical manipulation, is THERE a thorough investigation conducted and documented to determine the adequacy of the original process?
如果手工操作来重新制作成为必需而不是偶尔的话， 有没有一个彻底的调查及纪录来决定最初的制作过程是充分的？
13.2.3 Is appropriate action taken to minimise the risk of recurrence (e.g. if investigation of the nonconformance and/or review of the process reveals an abnormally high rate of batches that need to be recrystallised, it would be reasonable to incorporate the recrystallization as part of the normal process)?
有否合适的措施来把复发的风险减少到最低的水平（就是说， 如果不合格（产品/制作）的调查及/或者程序的回顾显示需要重新结晶具有非正常的，很高的的发生频率的话， 那么把再结晶作为正常制作过程的一部分将是合理的）？
你的东西翻得我很累。 肩膀很酸。 不知道你是公司用吗？制药设备的设计/评估？
13.2.9 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?
13.2.10 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?
13.2.2 如果它变得必要对更多比偶尔地再加工批由物理操作, 一次彻底的调查进行和被提供确定原始的过程的充足吗?
13.2.3 是适当行为被采取使再现减到最小(e. 风险g 。 如果不服从的调查和或过程的回顾显露需要被重结晶批的一种反常地高速率, 它会是合理合并再结晶作为正常过程一部分)?
在所有情况下，API及中间体的不合要求/标准的重要性及对关键的质量属性的影响是否足以证明重新制作是正当的/必须的？
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?
如果手工操作来重新制作成为必需而不是偶尔的话， 有没有一个彻底的调查及纪录来决定最初的制作过程是充分的？
是适当行为被采取使再现减到最小(e. 风险g 。 如果不服从的调查和或过程的回顾显露需要被重结晶批的一种反常地高速率, 它会是合理合并再结晶作为正常过程一部分)?