新的静脉注射液目视检查问答

GMP News
08/09/2016

New Q&A Document on the Visual Inspection of Parenterals available

新的静脉注射液目视检查问答

The Visual Inspection Group, an Interest Group of the ECA Foundation, has developed a new document with frequently asked questions. The new Q&A document, which was compiled by the Group's Board, is now available for a free of charge download on the website.

目视检查组，ECA组织的一个兴趣小组，制订了一份新的常见问题文件。新的问答文件是由该组委会汇集，现在可以在网站上免费下载。

For compiling the document the members of the Group were asked to provide their questions in February. These questions were then evaluated and answered by the Board Members.

在汇集期间，组成员在2月份提交了其问题。这些问题由组委会成员进行评估并解答。

The new document is structured as follows:

新的文件结构如下：

• Manual Inspection
• 人工检查
• Automated Inspection
• 自动化检查
• Qualification / Validation
• 确认/验证
• Test sets
• 测试系列
• Re-Qualification
• 再确认
• AQL-Tests
• AQL测试
• Defect Categorisation
• 缺陷类别
• Specific Products
• 特定产品
• Regulatory Affairs
• 法规事宜
• Process Control / SPC
• 工艺控制/SPC
  

Some examples for the questions and the respective answers:

以下是一些问题及其回答的样例：

The grey portion of fully automatic control is often checked manually, to return not clearly or fully tested products back to the inspection process. Is it allowed to carry out this testing with the automated inspection machine?	From a GMP view, there are no restrictions. It is also important here that at the end a yield calculation and evaluation in the batch record appears. And there are also automated inspection systems that have already integrated the double inspection with multiple cameras.
全自动控制的灰色部分通常是人工检查的，将没有清楚或全面检查的产品返回到检查过程。是否允许使用自动化检查机器实施这样的测试呢？	从GMP角度来看，并没有什么限制。但在结束时，收率计算和评估放在批记录中也是很重要的。还有自动化检查系统已经整合到多相机双重检查中。
In highly automated manufacturing lines for LVP flexible containers, the visual inspection process may/cannot comply to the standard visual inspection criteria e.g.: 5 sec inspection time, agitation of the container etc. Is this a compliance problem?	The requirements like 5 sec inspection time required by pharmacopoeias are addressing manually performed visual inspection. If the visual inspection is performed automatically, it is the company’s responsibility to ensure that the inspection via camera systems is as effective as a manual visual inspection via a validation (e.g. Knapp Test).
在LVP弹性容器的高度自动化生产线，目视检查过程可能/可能不符合标准目视检查标准，例如5秒检查时间，容器搅动等。这是否是符合性问题呢？	药典要求的如5秒检查时长这样的要求是对手动目视检查的说明。如果目视检查是自动实施的，则公司有责任通过验证确保通过照相系统所做的检查与人工目视检查一样有效（例如KNAPP测试）。
Should the AQL be inspected by QC or production	AQL manual inspection may be carried out by production staff (to avoid setting up a separate visual inspection team in QC) under a quality oversight or the quality unit. If performed by production operators, the AQL test should not be done by members of the team that was performing the 100 % visual inspection of the batch.
AQL是应由QC还是生产检查？	AQL人工检查可以由生产员工实施（以避免在QC设置一个单独的目视检查组），由质量监管或质量部门管理。如果由生产操作人员实施，AQL测试不应由对该批次实施100%目视检查的组成员实施。

The new Q&A document is available for members in the members' area on the Visual Inspection Group website free of charge. Membership in the Group is also free of charge and merely requires a registration.

会员可以在会员区免费下载上述问答。

The Good Practice Guide "Visual Inspection of medicinal products for parenteral use", was also revised. The new Version 3.0 will be introduced at the ECA Conference Particles in Parenterals in Barcelona, Spain, from 28-29 September 2016. All delegates of the conference will receive a free copy.

优良规范指南“静脉注射用药的目视检查”也进行了修订。新版本3.0将在2016年9月28-29日西班牙巴塞罗那ECA会议中进行介绍。