GMP实施指南生产和过程控制(4)

方式。Q7A 指南甚至是对关键操作，也没有总是要求第二个人签名。

2. Q. Does the second review of a critical processing step need to take place at the time the step is performed? Does the supervisor review following the unit operation meet this requirement? 问：关键工艺步骤的第二个人审核必须在反应步骤进行的时候进行吗？在单元操作结束后的 管理者审核是不是可以？

Sometimes there's no way to review it after the fact, and that's part of why Q7A put in the allowance for electronic or other means of verifying the critical steps. For example, if you're

adding a liquid, you may have a printout for your mass flow meter as to how much liquid went in. That together with what the knowledge of what was actually hooked up can be your second verification. So you need to have some justification if it is a critical step and you're not doing a review at the time.

答：有时候没有办法在事后进行审核，这也是Q7A 指南允许电子的或是其他的方式来证明 一些关键步骤。例如，如果你加了一种液体，你必须将你的物料流量表打印出来证明多少液 体被加进去了。这些一起说明实际加进去多少量，可以作为复核。如果是关键步骤，你又没 有在实施的时候进行复核的话，你就必须有一些合理的理由。

3. Q. What if a step has no specified time limit in the master production record, but you have an unexplained process delay? While waiting to make a solvent change, if you know that there's no quality impact, then what sort of deviation or documentation would be expected? 问：如果在主生产记录中有步反应没有特殊的时间限制，但是你还是发生了非预期的工艺延 迟。例如当你等着要更换溶剂的时候延迟了，如果你知道没有质量的影响，那么需要什么样 的偏差或是记录？

Even though you do not have a time limit in your master instruction, if you do have an abnormal delay, this is a deviation that should be evaluated. You want to use your science and your good common sense. If it were way out of the range from where you normally operate, it would be wise to document that.

答：即使你没有时间限制，如果你发生了非正常的延迟，这就是偏差，你必须调查。你可以 使用你的科学知识或是一般常识。如果它超过了你的正常操作的范围，那么最明智的做法就 是记录它。

4. Q. Section 8.3 regarding OOS. For example, the illustration, your target was to drive to an LOD of 2%, and after a number of hours, the LOD is at 2.5%. Further drying cannot drive the LOD lower than 2.5. Shall the 2.5% be considered as OOS?

原料药GMP 实施指南 8. 生产和过程控制 191

问：第8.3 部分关于超标的问题。例如，你的目标是获得干燥失重的指标，2%。但是几个 小时的干燥后，干燥失重的指标还是2.5%，再干燥都没有办法降低了。2.5%是不是超标？ Section 8.3 says, \performed for the purpose of monitoring and/or adjusting the process.\achieve the limit, then an investigation is appropriate to determine whether the problem is a bad result from the laboratory or whether it is process related.

答：第8.3 章节说，“超标调查一般不适用于中控测试，这些测试是用于监控和/或调整工艺 的。” 如果你的工艺没有达到规定的限度，那么进行适当的调查可以确定是实验室的结果错 误，还是和工艺相关的原因。

5. Q. Section 8.4 says that batches should have been tested prior to blending. Do you strongly recommend doing it prior to or is it possible for the company to take a business risk and test

individual batches at the same time that blending operation is taking place?

问：第8.4 章节说混粉前所有混粉批次必须检测。你是不是强烈建议在混粉前做测试? 公司 冒险在混粉操作进行的同时进行测试可不可以？

Typically you should test individual batches before blending. If you choose not to test individual batches before blending, you need a justification (written) to explain your rationale for any tests you are NOT performing before blending.

答：当然你应在混粉前进行每个批号测试。如果你选择在混粉前不测试每个批号，你必须有 书面的合理理由来解释，为什么你在混粉前没有进行任何测试。

6. Q. Under what conditions can quality typically delegate authority for releasing Intermediates to production?

问：在什么情况下质量部门可以被替代来放行生产用中间体？

As described in section 8.3 of Q7A, \department personnel and the process adjusted without prior quality unit(s) approval if the

adjustments are made within pre-established limits approved by the quality unit(s). All tests and results should be fully documented as part of the batch record.\\qualified production personnel or other units following procedures approved by the quality unit(s).\

答：Q7A 指南第8.3 章节规定，“中控可以由有资质的生产部门的人员进行，并可在质量 部门事先批准的范围内对生产工艺进行必要的调整。”所有检验结果都必须作为批记录的一 部分归档保留。” 第6.7 章节更进一步说“非关键工艺步骤的生产和实验室控制记录可以由 有资质的生产部门或是其他部门的人员根据质量部门批准的规程来审核。”

【要点备忘】

? 产品生产过程中的污染控制措施是否合适，包括微生物的控制以及粉尘等外来物质 的控制。

? 对污染和交叉污染的措施应定期评估。 ? 清场和清洁。__

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