最终版公布：EU GMP附录16关于QA认证和批放行

20151014 ECA新闻：最终版公布：EU GMP附录16关于QA认证和批放行  
GMP News
14/10/2015
Finally published: new Annex 16 on QP Certification and Batch Release
最终版公布：EU GMP附录16关于QA认证和批放行
The European Commission has published the final version of the revised EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release". Deadline for coming into operation is 15 April 2016.
EC刚公布了修订后的EU GMP指南附录16“质量授权人认证和批放行”。其最迟实施日期为2016年4月15日。
As one important topic, it has been pointed out that the major task of a Qualified Person (QP) is the certification of a batch for its release. In this context, the QP must personally ensure the responsibilities listed in chapter 1.6 are fulfilled.  In chapter 1.7 a lot of additional responsibilities are listed which need to be secured by the QP. The work can be delegated and the QP can rely on the respective Quality Management Systems. However "the QP should have on-going assurance that this reliance is well founded" (1.7). Amongst these twenty-one tasks are for example:
作为一个重要的主题，指南里指出了QP的主要任务是主证其放行的批次。在些情况下，QP个人必须确保履行在第1.6章中所列出的职责。在第1.7章中，列出许多其它的职责，也是需要QP来完成的。这些工作可以被委托给其它人，QA可以依赖于相应的质量管理体系。但是，“QP应持续保证这种依赖是有良好基础的”（1.7）。在这21项任务中，包括以下例子：
Starting materials comply and the supply chain is secured, including GMP assessments by third parties
起始物料符合要求，供应链受到保证，包括第三方进行的GMP评估
The necessary audits have been performed and the audit reports are available
实施了必要的审计，有审计报告
Manufacturing and testing performance are compliant with the MA
生产和检验表现符合MA
Manufacturing and testing processes are validated
生产和检测过程经过验证
Changes have been evaluated and investigations completed
变更经过评估，调查已完成
It is important to mention in this context that "the ultimate responsibility for the performance of an authorised medicinal product over its lifetime; its safety, quality and efficacy lies with the marketing authorisation holder (MAH). However "the QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force (…), in accordance with the requirements of the marketing authorisation (MA) and with Good Manufacturing Practice (GMP)" (see General Principles).
重要的是在这此上下文中“上市许可持有人（MAH）对批准的药品在其生命周期 中的安全性、质量和有效性负有无限责任”。但是，“QP具有职责确保每个单独的批次均根据强制法令要求进行生产和检查（……），符合上市许可（MA）的要求，以及优良生产规范（GMP）的要求”（参见通则）。
In the case that the QP has to rely on the correct functioning of the quality management system of other sites, the QP "should ensure that a written final assessment and approval of third party audit reports has been made". The QP should also "be aware of the outcome of an audit with critical impact on the product quality before certifying the relevant batches."
如果QP必须依赖于其它场所质量管理体系的正确运行，则QP“应确保有书面的最终评估，以及对第三方审计报告的批准”。QP还应“在认可相关的批准之前明白审计的结果对产品质量具有关键的影响”。
Another important section clarifies the role of the QP when it comes to deviations, implementing main features of the EMA Position Paper on QP Discretion (which was issued in February 2006 and updated January 2008). Chapter 3 of the draft describes the "handling of unexpected deviations". A batch with an unexpected deviation from details contained within the Marketing Authorisation and/or GMP may be certified if a risk assessment is performed, evaluating a "potential impact of the deviation on quality, safety or efficacy of the batch(es) concerned and conclusion that the impact is negligible." Depending on the outcome of the investigation and the root cause, the submission of a variation to the MA for the continued manufacture of the product might be required.
另一个重要部分说明了当有偏差时QP的作用，执行EMA关于QP自由裁量的立场文章的主要内容（该文件于2006年2月签发，2008年1月更新）。草案的第3章描述了“处理预期外偏差”。一批产品如果有发生预期外的偏差，偏离上市放可和/或GMP里的详细要求，如果进行了风险评估，评估了“偏差对受影响批次的质量、安全性或有效性的影响，并且做出的结论是可以忽略”，则也可以认证放行。根据调查结果和根本原因不同，可能会需要提交MA变更，以持续产品的生产。
During the consultation phase, stakeholders expressed their concerns regarding the sampling of imported products. Now the new annex is clear on this: "Samples may either be taken after arrival in the EU, or be taken at the manufacturing site in the third country in accordance with a technically justified approach which is documented within the company's quality system. (…) Any samples taken outside the EU should be shipped under equivalent transport conditions as the batch that they represent."
在咨询阶段，干系人表达了关于进口产品取样的关注。现在新的附录对此点有了清楚的说明：“可以在到达EU后，在第三国生产场所根据技术论证的方法进行取样，并且在根据 公司的质量体系进行文件记录。（……）所有在EU以外取的样品应在与其所代表的产品批次相等同的运输条件下运送”。
The new annex is rather short on other importation requirements. These requirements will probably be defined in the new Annex 21.
新的附录在对其它重要的要求非常之短。这些要求可能会在新附录21中定义。

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201591411386898/

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