ECA-GMP确认、再确认.pdf

Qualification, Requalification - frequent Obscurities 确认、再确认常见的疑问 ECA GMP 新闻 2013 年10 月2 日 1、总则 有关确认、再确认及监测经常会被搞混，尤其是在GMP 环境下使用不同的ISO 惯用语， 因此以下对于这三个词进行解释并以水系统为例进行举例说明。 根据GMP 的大体定义： 确认：确保新的设备、厂房或是即将使用的设备满足既定用途 再确认：保证在变更或是给定周期的周期性设备评估内设备仍处于合格的状态 监测：对于设备或者系统的监督，可以是连续的、也可以是间断的 但是对于再确认而言需要更详细的解释，严格上来说，再确认在欧盟附录十五中并 没有被提及。但是再验证是有相关描述的，而确认常被理解为验证的一部分，再确认也 是必须的，并没有设定的时间标准，但须规定实施定期的再确认。这些并不是需要满足 基本要求，而是与系统相关并要基于风险评估。很多情况下，再确认是3-5 年。以注射 剂全自动灯检系统为例，一般是1-2 年。很重要的是，再确认不要被理解成验证工作的 重复。经常的，在设备没有变更的范畴内，没必要进行新的测试或测量。再确认就是常 规操作的一个数据回顾。因此，质量相关设备、质量标准参数及一段时期内设备变更及 偏差会被分析到。对于台账的分析也是评估的一部分，还有 GMP 审查员不会认为年度 质量回顾可代替再确认。 The terms qualification, requalification and monitoring are often mixed up, especially if the somewhat different language from ISO standards is used in the GMP environme nt. Therefore, the three terms will be explained in the following and then differentiated one from the other by way of the examples watersystem and clean room. General definitions according to GMP: Qualification: ensuring in the case of new equipment/facilities or equipment entering into service that they serve their intended purpose Requalification*: ensuring that the equipment is still in the qualified state after a change AND periodical assessment of eqipment within defined time intervals Monitoring: supervision of equipment or a system - this can be performed continuously or discontinuously But the topic of requalification* needs to be considered in more detail. Strictly speaking, requalification is not mentioned in Annex 15 of the EU Guidelines to Good Manufacturing Practice which is the guidance document for qualification in Europe. But revalidation is described (e.g. article 45) and since qualificati