FDA关于注射剂人工灯检的要求

甘晓阳

各位老师，还是想跟大家讨论一下，FDA关于注射剂人工灯检的要求具体如何 ，我们做了个差距分析，分析出来的差距都不是很明确，措施也不现实。可能也是我们对法规理解不透，想学习一下各位同仁公司的做法！

甘晓阳

一.FDA法条：Types of Test Sets: The particle detection threshold can be determined for a specific inspection method and product/package combination. It is a standard curve of detection probabilities at various particle types and sizes in an approximate range of 100–500 µm (with recommended increments of 100 µm). Fibers are typically observed in sizes >500 µm.
For example, for clear solutions in 10-mL tubing glass vials, past threshold studies indicate that particles within the range of 150–250 µm (500–2000 µm for fibers) can be detected with a PoD of 70% or greater.
Depending on product and/or presentation, rejects in the test set should represent all defects anticipated for a given container type or product family. For particles, use a bracketed range of types (densities) and sizes from near the lower limit of the visible
range (100 µm) to the largest routinely observed in the pool of rejects. For an individual manual test set, it is important that all containers and closures are of the same type, and the samples are blinded.
If significantly different formulations (e.g., clear solution, suspension, lyophilized) or packages (e.g., clear vials, amber vials, ampoules, syringes) are produced at the same facility, separate test sets should be prepared to represent each unique combination
USP规定：粒子检测阈值可以针对特定的检查方法和产品/包装组合来确定。大约为100–500 µm 范围内的各种粒子类型和大小（建议增量为100 µm）。纤维尺寸 >500 µm。
例如，对于 10 mL 透明玻璃容器，过去的阈值研究表明，可以检测到 150–250 µm（纤维为 500–2000 µm）范围内的颗粒PoD 为 70% 或更高。根据产品/包装，测试集中的不合格品应代表给定容器预期的所有缺陷类型或产品系列。粒子大小范围从100 µm到在废品池中常规观察到的最大尺寸。

二.我们目前的措施计划是：
1.由生产部门采购具有标尺的放大镜，制备尺寸大小约为200μm左右的单粒子可见异物缺陷品，基于此对所有灯检人员在实操考核前先进行识别可见异物可识别大小的阈值研究（理论PoD应大于70%）；
2.在《灯检人员资质确认管理规程》中补充可见异物可识别大小的阈值研究的相关内容

不知我们的理解是否到位，希望能得到各位老师的指点！！

翾遥

不知道是否有帮助，我也来发表一下我的看法：人眼可见的微粒是＞50μm；结合USP所提到的“100-500微米范围内的各种粒子大小”，如果可能的话，把缺陷品的尺寸制作的再小一些可能会更为合适？另外，基于这个测试只是用于对可见异物识别能力的一个阈值研究，我个人认为将这个测试放在实操考核前/后都可以，并且在测试完成后可能需要将结果整合输出为一份记录或者报告，记录人员的识别能力

徐龙

甘晓阳 发表于 2021-8-23 16:31
一.FDA法条：Types of Test Sets: The particle detection threshold can be determined for a specific in ...

写的很好。。。。

小金库

感谢分享，先收藏