ECA注射剂中颗粒物会议上FDA的演讲

GMP News
26/10/2016

FDA presentation at the ECA Conference Particles in Parenterals

ECA注射剂中颗粒物会议上FDA的演讲

Dr Stephen Langille from the US FDA gave a talk on the FDA's current thinking with regard to the visual inspection of medicinal products for parenteral use. In his presentation he showed the number of recalls caused by visible particulate matter over the last 11 years. For him, most of the recalls were justified when the types of particles found were taken into consideration. He also emphasized that something is possibly wrong in the visual inspection process if particles found in the market are bigger than 1000 ?m.

来自美国FDA的Dr Stephen Langille做了关于FDA对注射药品目视检查方面当前考虑的讲话。在他的演讲中展示了在过去11年中由于目视颗粒物引起的召回的数量。他认为，大多数召回是在考虑到所发现的颗粒物的类型时决定的。他还强调说，如果上市销售的药品中所发现的颗粒物超过1000?m，则可能目视检查的流程有问题。

The prevention of particles is very important to him. From his perspective the best particle is one which is not in the product. Also important to him are threshold studies, meaning to show the minimum particle size which can still be detected (dependent of product and type of container). These threshold studies are crucial for the setup of the test sets and the qualification of the inspectors of the manual inspection. He also mentioned the semi-automated inspection process. For him semi-automated inspection is good for detecting container-closure issues, like missing stoppers. But he also questioned whether an inspection time of about one second is suitable to detect particles with a size of 200?m for example. In the discussion he was asked about FDA's opinion on the USP chapter <790>. In his opinion, USP chapter <790> can be an effective tool for ensuring that the manufacturing process and 100% inspection process are adequate to limit visible particle contamination. However, cGMPs must be followed during the manufacturing and visual inspection process. Meeting the requirements of USP <790> should not be used to excuse not meeting cGMPs.

他觉得防止颗粒物是非常重要的。他认为最好的颗粒是不在药品中的颗粒。他还认为阈值研究很重要，意思是说显示可以检出的最小粒径（取决于产品和容器类型）。这些阈值研究对于测试系列的设置，和人工检查的检查员资质非常关键。他还提到了半自动检查流程。他认为半自动检查有利于发现容器密闭器问题，如塞子缺失。但他也质疑约为1秒的检查时间是否适合于发现200?m的颗粒物。在讨论中，他被问到FDA对USP<790>的意见。他认为，USP<790>可能是保证生产过程和100%检查流程足以限制目视颗粒物污染的有效工具。但是，在生产和目视检查过程中必须遵守CGMP。符合USP<790>的要求不应成为不符合CGMP的借口。

You will find the complete presentation in the members area of the ECA webpage.

在ECA会员区可以找到完整的演讲稿。

来源：Julia