欢迎您注册蒲公英
您需要 登录 才可以下载或查看，没有帐号？立即注册
x
MANUFACTURING PROCESS CHANGES 1. Q: If no range was established through validation studies for mixing time, is it possible to make a level 1 change in mixing times? 1.问题：如果通过验证研究没有确定混合时间的范围，是否可能对混合时间进行1 级变更？ A: This situation does not qualify as a level 1 change. 回答：这种情况不符合1 级变更的要求。 2. Q: If a parameter is not specified in the application (e.g. mixing speed), and you want to change it, is the change within range or outside? 2.问题：如果一个参数在申报时没有指定（例如混合速度），而想改变它，这一变更是否超出了范围？ A: If the approved application does not contain the necessary details (e.g., mixing speed), and one wants to change the method of manufacture of the drug product (i.e., equipment and/or process with associated parameters), a prior approval supplement should be filed. 回答：如果批准的申请没有包含必需的细节（例如混合速度），而想更改药品的生产方法（即设备和/或工艺及相关的参数），则应按Prior approval supplement申报。 MANUFACTURING EQUIPMENT CHANGES 1. Q: When going from equipment of one scale to one which is 2 or 1/10 the scale, the operating parameters will always change (e.g., airflows will decrease, spray rates will decrease). It is unlikely that the parameters will have been previously validated. Therefore, it would appear that any such change will be a level 2 change. Please comment. 1. 问题：当设备由一个规模改为原规模的2/10或1/10时，操作参数总是变化（例如气流将降低，喷洒速度降低）。参数不大可能事先经过验证。因此这类变更似乎应属于2 级变更。请予以指正。 A: If a scale-down of the production batch to 2 or 1/10 the size is needed, operating parameters that would fall within the range established for manufacture of the test batch and the first three production batches (i.e., validation batches) will be regarded as a level 1 change. If they fall outside the validation ranges the change would be permitted under SUPAC IR as a level 2 change. Regardless, SUPAC IR does not address scale-down below 100,000 units. 回答： 如果需要将生产批次的规模缩小至2/10或1/10，操作参数应当在为生产试验批次和最初3 个生产批次（即验证批次）所确定的范围内，则认为是1 级变更。如果超出了验证范围，则变更应按SUPAC-IR 的2 级变更处理。尽管如此，SUPAC IR也不适用于规模缩小到100000单位以下的情况。 2. Q: Is a change in mill screen size (to improve flow during formulation) a level 1 change? 2. 问题：粉筛尺寸的变更（配方过程中用来提高流量）是否为1 级变更？ A: A screen size change to an alternate screen of the same design (holes) and operating principle (sifting) but different diameters to facilitate flow of powder will be regarded as a level 1 change, provided the alternate screen has not altered the particle size distribution of the screened material. Under such conditions, the information can be filed in the annual report. 回答：筛子尺寸改为相同设计（孔）和操作原理（过滤）但不同直径以利于粉末流动的其他筛子应当认为是1 级变更，但前提是替代的筛子没有改变所筛的材料的颗粒大小分布。这些情况下，可以在年度报告中上报备案。 3. Q: Must the equipment be moved from the old site to the new one when the manufacturing site is changed? 3. 问题：当产地变更时，设备是否必须从原来的地点转移到新的地点？ A: A company need not move equipment for a SUPAC-IR site change. However, any equipment should be of the same design and operating principle as the old equipment, and the SOPs and formulation should be the same. 回答：对于SUPAC-IR地点变更，公司不需要移动设备。但所有设备的设计和操作原理必须与原设备相同，标准操作规程和配方也应当相同。 | 
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
发表于 2017-8-12 08:07:18
置顶卡
变色卡
楼主
谢谢分享，学习中...