USP monograph<1790> "Visual Inspection of Injections" comes into force USP 美国药典专论<1790>“注射液灯检”生效 The long-awaited new monograph <1790> of the US Pharmacopoeia about the visual inspection of injections finally came into force on August, 1st. Chapter<1790> with its number >1,000 is not mandatory; it's considered to bean explanatory text for the already published chapter <790> "Visible Particulates in Injections", which is mandatory in the US. 期待已久的美国药典关于注射液目测的新专题<1790>最终于8月1日生效。第1790条，其数量大于1,000不是强制性的; 它被认为是已经出版的章节<790>“注射中可见异物”的解释性文本，这在美国是强制性的。 Chapter<1790> had first been published in the Pharmacopeial Forum PF 41(1).Shorty after that, a revised version was published in PF 41(6).That was in 2015 and ever since then, little has been heard about the new chapter. With the entry into force of USP 40 NF 35, it finally came into effect on August, 1st 2017. The final version is not 100% identical to the one which had been published in PF 41 (6); there were substantial changes in some explanations. 第1790章第一次在药典PF 41（1）出版。之后2015年，在PF 41（6）中发布了一个修订版本。从那时起，关于新章节听到的不多。随着USP 40 NF 35的生效，它最终于2017年8月1日生效。最终版本与PF 41（6）中已发表的版本不完全相同。一些解释有重大变化。 One of the reasons for the gap between initial publication and entry into force were discussions with the authorities on the AQL concept. The USP had introduced it in chapter <790> and elaborated on it in the draft for chapter<1790>. Even though the AQL concept allows to make the vague requirement"practically free from particles" statistically comprehensible, there is a fear of GMP obligations being neglected if a batch meets the AQL requirements in spite of anomalies. In case of anomalies on the market,for example, it should not be sufficient to perform AQL tests on the retain samples and - if that were successful - not to start further investigation of the defect found on the market. 初步出版和生效之间差距的原因之一是与当局就AQL概念进行了讨论。USP在第790章中介绍了这一点，并在第1790章的草案中作了详细阐述。即使AQL概念允许“实际没有颗粒”的模糊要求在统计上是可理解的，但如果尽管有异常情况，即使批次满足AQL要求，GMP义务也很容易被忽略(译者注：AQL, AcceptableQuality Limit，即“可接受质量限度”)。如果市场出现异常情况，例如，对保留样本进行AQL测试是不够的，如果成功了，就不会对市场上发现的缺陷进一步调查。 There is no comparable approach in the European Pharmacopoeia so far, and no signs of that changing in the fore seeable future. On the other hand, performing the AQL test(or something comparable) is already state-of-art also for European pharmaceutical companies. 到目前为止，欧洲药典没有可比较的方法，在可预见的将来也没有改变的迹象。另一方面，进行AQL测试（或可比较的东西）已经是欧洲制药公司的最先进的测试。 原文来自ECA官网  gmp-compliance.org/gmp-news/usp-monograph-1790-visual-inspection-of-injections-comes-into-force