20150204 ECA新闻：USP<1790>注射剂目视检查公布

20150204 ECA新闻：USP<1790>注射剂目视检查公布  

2015-02-05 22:17:20|  分类： ECA新闻

原文网址：http://www.gmp-compliance.org/enews_04682_USP-Chapter--1790--Visual-Inspection-of-Injections-published.html

USP Chapter <1790> Visual Inspection of Injections published

USP<1790>注射剂目视检查公布

The long-awaited USP Chapter <1790> regarding the 100% visual control of injectables has now been issued as a first draft in the Pharmacopeial Forum 41(1) for commenting.

期待已久的USP<1790>关于100%目视控制注射剂的章节现在发布在药典论坛41（1）征求意见。

The new chapter is comprised of the following sub-chapters:
1. Scope
2. Introduction
3. Typical Inspection Process Flow
4. Inspection Life-Cycle
5. Interpretation of Results
6. Inspection Methods and Technologies
7. Qualification and Validation of Inspection Processes
8. Conclusions and Recommendations
9. References

新章节由以下子章节组成：

1.      范围

2.      介绍

3.      一般检查流程

4.      检查生命循环

5.      结果诠释

6.      检查方法和技术

7.      检查过程的确认和验证

8.      结论和建议

9.      参考文献

This new informative chapter is applied to the manual, the half-automatic and the fully-automated inspection of parenterals. It mainly aims at controlling particles (>50 ?m), but also comprises indications to further defects like cracks in primary containers or poorly fitting stoppers. In Chapter 2 there are also general statements regarding the patient risk due to particulate matter with regards to the size and type of the particulate impurity and the patient's condition or age. It is interesting that this is expanded in Chapter 4 where possible particle sources (stopper, glass, silicon etc.) are mentioned together with the request to prevent any generation of particles. The Sub-chapter 4.2.1 aims at avoiding of intrinsic particles already in product development - e.g. through the prevention of glass delamination, by choosing appropriate formulations and according stability studies. Supplementary, Chapter 4.3 is dedicated the removal of particles, e.g. by washing primary containers and the associated particle depletion studies.

该新的参考章节适用于人工、半自动和全自动注射剂检查。它的主要目的是控制颗粒(>50 ?m)，但也会发现另外的缺陷如内包材碎裂或瓶塞不到位。在第2章中，还有一份关于不同大小颗粒物和颗粒型杂质引起患者风险，以及患者条件或年龄的声明。有意思的是该内容在第4章中进行了展开，讨论了可能的颗粒来源（塞子、玻璃、硅胶等）以及防止产生颗粒的要求。子章节4.2.1目的是避免研发过程带来的产品固有的颗粒，例如，通过挑选适当的配方并根据稳定性试验来防止玻璃分层剥离。还有，第4.3章专门讲述如何去除颗粒物，例如，通过对内包材进行清洁，对相关的颗粒物清除进行研究。

As already described in the USP Chapter <790> the AQL testing is supposed to be part of the evaluation of a batch. For that purpose samples are drawn from the good proportion of the tested batch according to defined sampling plans. These samples are then tested again to evaluate the quality of the preceeding 100% control. The AQL limits named exemplarily in Chapter <17990> are more strict, though, as those in the ECA Best Practice Paper for the visual control.

在USP<790>中已要求将AQL测试作为批评估的一部分，因此，要根据拟定的取样计划从被测批次的好的那一部分中抽取样品。这些样品要重新进行测试，以评估质量为100%受控。AQL限度在<17990>章中更为严格，与ECA最佳规范书中对目视控制的相同。

Some practical tips are contained in Chapter 5. For instance, it is suggested there to enhance the illumination to 10.000 Lux and to possibly screen the containers from the back when testing brown glass or plastic containers as a visual control for these containers is difficult to conduct.

在第5章中有一些实用性提示。例如，建议将光照度增加到10000LUX，在包材为棕色玻璃或塑料瓶时，尽可能地将包材与背景区分开，因为对这些包材进行目视检查是很难的。

Chapter 7 (Qualification/Validation of inspection processes) is mainly directed towards the manual visual inspection. It comprises tips for the creation of test sets and the qualification as well as the re-qualification of personnel. The application of Knapp tests for determining the detection rates is also mentioned there. However, there are only very few tips for the fully-automated inspection, and there are no details referring to the qualification or re-qualification of fully-automated inspection processes.

第7章（目视程序的确认/验证）主要指导人工目视检查。它对于创建检查序列以及人员的资质确认和再确认给出了一些建议。还提到了采用KNAPP测试来确定检查率。但是，对于全自动检查只给出了很少的建议，对于全自动检查程序没有给出确认或再确认的详细信息。

The draft of the new Chapter <1790> is available online on the USP website. You will only need to register, which is free of charge, though. The deadline for comments is the 31 March 2015.

新的<1790>章现在可以从USP网站在线获得。你只需要免费注册即可。征求意见的截止日期为2015年3月31日。

来源：http://zhuyujiao1972.blog.163.com/blog/static/9869472720151592523388/

感谢楼主的分享