ECA 欧洲药典：新章节 可见异物目视检查

鲜橙汁

European Pharmacopoeia: New Chapteron Visual Inspection for Visible Particles

欧洲药典：新章节-可见异物目视检查

The EDQM haselaborated a new chapter on testing of parenterals for visible, particulatecontamination - as you could already read in New Ph. Eur. Developments in the Visual Inspection of Injectables. The newchapter is of advisory nature. Indeed, it is entitled "Recommendationson testing of particulate contamination: visible particles". Ithas now been officially published for comments in Pharmeuropa 30.4. Therequirements for the test methods used for the test on visible particles canstill be found in the mandatory chapter 2.9.20. Particulatecontamination: visible particles.

The new chapterdifferentiates extrinsic particles from intrinsic ones. The firsts areimpurities from the environment, equipment or packaging like for example hair,fibres or glass. The latter are impurities from the formulation, the product orthe excipients themselves, or the process such as proteinaceous particles,silicone droplets, or inorganic precipitates. Both types of particles should beavoided. However, it is indicated that the particle may be the product itselfin some medicines (like in cell therapy or dispersions).

Besides, it ispointed out that some products may be difficult to visually inspect because oftheir nature like for example opalescent, coloured or opaque solutions, orlyophilisates too. In such cases, measures should be taken to improve thedetection rates. They include - among other things -  extended inspectiontimes to more than 5 s against both black and white backgrounds, orthe use of light intensities higher than 3750 lux (asdescribed in chapter 2.9.20).

For the firsttime, the Ph.Eur. speaks of an additional AQL testing withregard to  ISO standard 2859-1 in the context of a 100 per centinspection. This testing should confirm that the 100 per cent inspection hasbeen performed correctly and that all containers with particles havebeen eliminated. According to the EDQM, different AQL levels should be defined,for example for minor, major or critical defects.

In addition,according to the new chapter it is possible to omit anadditional quality control test for particles in the context of thebatch release, if both the 100 per cent inspection performed during production(manual or automatic) and the AQL testing were successful. This doesn't applyto lyophilisates where additional samples have to be reconstituted andtested.

Yet, the newchapter states that although the objective is zero particle procontainer,  this is in reality not realistic because visual inspection isprobabilistic in nature. No general recommendation is given on that.

The new draftchapter is in compliance with the Best Practice Guidance document of the ECA Visual Inspection Group.

The new chapteris freely available on the EDQM website under "Texts forcomment" after registration (for free).

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EDQM为可见的颗粒污染测试了肠外营养学的新篇章 - 正如您已经阅读过New Ph.Eur。注射剂目视检查的进展。新章节具有咨询性质。实际上，它的标题是“ 推荐测试微粒污染：可见颗粒 ”。它现已正式发表在Pharmeuropa 30.4的评论中。用于可见颗粒测试的测试方法的要求也可以在强制性的第2.9.20章中找到。颗粒污染：可见颗粒。
新章节将外在粒子与内在粒子区分开来。第一，是来自环境，设备或包装的杂质，例如头发，纤维或玻璃。后者是来自制剂，产品或赋形剂本身的杂质，或诸如蛋白质颗粒，硅氧烷液滴或无机沉淀物的过程。应该避免这两种类型的颗粒。然而，表明颗粒可能是某些药物（如细胞疗法或分散体）中的产物本身。
此外，还指出一些产品可能难以视觉检查，因为它们的性质，例如乳白色，有色或不透明的溶液，或者也可以是透明质酸盐。在这种情况下，应采取措施提高检测率。它们包括 - 除其他外 -   对黑色和白色背景延长检测时间超过5秒，或者使用高于3750勒克斯的光强度（如第2.9.20章所述）。
第一次，Ph.Eur。在100％检验的背景下，在ISO标准2859-1中提到额外的AQL测试。该测试应确认100％检查已正确执行，并且所有带有颗粒的容器都已消除。根据EDQM，应定义不同的AQL级别，例如，对于次要，主要或严重缺陷。
此外，根据新章节，如果在生产（手动或自动）和AQL测试期间执行的100％检查都成功，则可以在批次发布的背景下省略对粒子的额外质量控制测试。这不适用于必须重构和测试其他样品的冻干物。
然而，新章节指出，虽然目标是零粒子，但这实际上是不现实的，因为视觉检查本质上是概率性的。没有就此提出一般性建议。
新的草案章节符合ECA视觉检查组的最佳实践指导文件。
新章节可在注册后免费在EDQM网站的“文本评论”下免费获取。

坐井观天儿

多谢分享,如果把电子版的全文挂上来就更好了。

syhorchid

了解一下

小敏敏1

谢谢分享            

小金库

谢谢楼主分享！