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FDAPerspective on Risk Management and its Influence on Quality - InspectionDeficiencies 2015 FDA风险管理及其对质量影响的愿景----2015年检查缺陷 In the framework of a conference on Quality and Manufacturing,David J. Jaworski, Senior Policy Advisor of CDER's Office of Manufacturing andProduct Quality gave a presentation on risk management and its influence onquality. The slides of his presentation are now freely available. 在质量和生产会议上，DavidJ. Jaworski，CDER办公室生产和药品质量资深政策顾问发表了风险管理及其对质量影响的演讲。现在可以免费获取该演讲幻灯。 The presentation starts quoting Theodore Roosevelt:"Risk is like fire: If controlled it will help you; if uncontrolled itwill rise up and destroy you" - and Trevor Levine: "Risk Managementis about people and processes and not about models and technology." 幻灯以西奥多·罗斯福的名言开始，“风险如火：受控则助尔，失控则毁汝”----以及崔佛·莱文的名言“风险管理与人和流程有关，与模型和技术无关”。 Then, he carried on stating the most frequent inspectiondeficiencies in 2015: 然后，他开始陈述2015年最频繁的检查缺陷： - 21 CFR 211.22(d): Quality Unit responsibilities 质量部门职责
- 21 CFR 211.160(b): Laboratory controls 化验室控制
- 21 CFR 211.192: Investigation failures 失败调查
- 21 CFR 211.113(b): Microbiological controls 微生物控制
- 21 CFR 211.100(a): Production process 生产工艺
- 21 CFR 211.42(c)(19(iv): Environmental monitoring 环境监测
- 21 CFR 211.68(a): Electronic equipment controls 电子设备控制
Under the title "Risk Reduction is Hard Work",he gave three examples: 在“风险降低是一个艰难的工作”标题下面，他举了三个例子： The first example deals with tablet blend uniformitywhich has been improved by replacing direct pressing through wet granulation.Besides, the process had been continuously operated and assisted by ProcessAnalytical Technologies (PAT) applications. 第一个例子是通过替代湿法制粒直接压片来改进片剂混合均一度。此外，使用了PAT工具让工艺可以连续运行。 The second example concentrates on sterile productionfocussed on microbiological risks and human intervention. For Jaworski, thedifference between a classical cleanroom and a Restricted Access BarrierSystems (RABS) is that - through human intervention in the laminar flow -classical cleanrooms are subject to higher risks than RABS. According to him,completely encapsulated systems present the lowest risks. 第二个例子是关于无菌生产中的微生物风险和人员干预的风险。Jaworski认为，传统的洁净区和RABS之间的区别是----由于人员在层流中的干扰-----传统的洁净区会比RABS的风险更高。他认为，完全囊包的系统风险是最低的。 Finally, the third example on manufacturing documentationshows how electronic systems - provided they are well designed - can helpreducing risks and errors. For Jaworski, it is a general problem that SOPs andbatch documentation are often written in a not very user-friendly way by thescientists. Partially, employees even require SOPs to be able to fulfil batchdocuments at all. Yet, even if the paper document is well designed, the risk oferroneous entries still remains. According to Jaworski, the change to anelectronic system doesn't always reduce the risk of erroneous entries becausewhen badly designed batch documentation is duplicated into an electronic version,the document is and remains a badly designed document with the same risks oferrors. For Jaworski, an electronic system which ideally leads the employeethrough the entire manufacturing process and only requires a few manual entriescould help strongly minimising risks. 最后，第三个例子是生产文件记录显示出电子系统----如果设计的足够好的话-----如何帮助降低风险和错误。Jaworski认为，常见的问题是SOP和批记录通常是由技术人员写就的，其编写方式并不适合使用者。有时候，员工甚至要求SOP能够完成所有批记录。即使纸质文件设计的非常好，错误填写的风险仍然存在。Jaworski认为，对电子系统的变更并不总会降低填写的错误风险，因为如果设计的不好的批记录复制成为电子版本，文件仍然是设计不好的文件，有相同的错误风险。Jaworski认为，理想地引导员工录入整个生产过程，只要求很少的手动输入的电子系统有助于大大降低风险。 In a perfect world, such a system would also performerror checks. 理想状态下，这样的系统也能进行错误检查。 更多信息参见题为“管理质量风险：优与劣”。
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发表于 2016-12-13 21:48:48
置顶卡
变色卡
发表于 2016-12-13 22:42:52
楼主
那必须是行