20170830 ECA新闻：ECA验证组---活动更新

30.08.2017

ECA Validation Group- Update on Activities

ECA验证组---活动更新

The ECA Validation Group was established with the goal togather knowledge on validation, for example by continuously developing aProcess Validation Good Practice Guide. The summary below will provide moredetails about recent and future activities.

ECA验证组建立的目标是收集验证方面的知识，例如持续发展的工艺验证优良规范指南。以下总结是关于其最近和未来活动的更详细介绍。

ECA's 7th GMP Conference in Prague: ProcessValidation

ECA在布拉格第7次GMP会议：工艺验证

At ECA's GMP Conference in Prague in May/June almost 50delegates participated in a workshop on the EU Annex 15 enforcement and theMutural Recognition Agreement (MRA) between the US FDA and EMA. The updatedAnnex 15 has been mandatory since 1. October 2015 and many European (andinternational) companies have not finished implementing it. Especiallyinternational companies with products on the US market have had challenges inthe implementation since FDA's Process Validation Guide from 2011 is differentin its wording, even though it is not in its principles.

在ECA的布拉格5/6月GMP会议上，有约50位代表参加了一个EU 附录15实施和美国FDA与EMA之间互认协议（MRA）的研讨会。更新后的附录15自2015年10月1日起强制实施，许多欧洲（和国际）公司尚未完成实施。尤其是有产品在美国市场销售的国际公司还在面临2011年FDA的工艺验证指南实施的挑战，该指南与EU附录15尽管原则没有大不同，但在用词上有所不同。

ECA Qualification and Validation Task Team

ECA确认和验证任务团队

ECA has established a 'Qualification and ValidationTask Team' within the validation group, which consist of both suppliersand pharmaceutical companies to enable a cost effective approach toqualification that supports the new Annex 15 as life-cycle activities, all theway from process development through commercial production and until a productis eventually discontinued. Now also equipment and manufacturing systems shouldbe managed within a life cycle and can be more effective if the main suppliersunderstand the concept. The plan is to develop a Good Practice Guide that willbe released in September 2018 at a conference focusing on cost-effectivecommissioning and qualification projects together with pharmaceuticalsuppliers, including equipment and system suppliers.

ECA已在验证组内建立了一个“确认和验证任务团队”，它由供应商和制药公司组成，主要是促进有效成本的验证方法，支持新的附录15作为生命周期活动，即从工艺开发于商业化生产，直到产品最终退市的所有过程。现在设备和生产系统也应该在其生命周期内进行管理，如果主要供应商了解此概念，其实可以做的更有效。其计划是建立一个优良规范指南，该指南计划于2018年9月的一个会议上发布，该会议主要关注与药品供应商一起的成本效益调试和确认项目，包括设备和系统供应商。

Ongoing Process Verification - the EMAperspective

持续工艺核查---EMA观点

One of the areas of the updated Annex 15 is the conceptof Ongoing Process Verification (OPV) which is similar to FDA's ContinuedProcess Verification (CPV) to ensure and document that manufacturing processesare maintained in a state of control throughout the commercial manufacturing.

更新后附录15的领域之一是持续工艺核查的概念（OPV），这与FDA的持续工艺确认（CPV）是类似的，是为了确保和记录生产工艺在商业化生产过程中维持在受控状态。

There are significant differences in how companiesimplement their OPV programs and over the last couple of years the ECA courseon OPV has shared some of these examples from companies with very good results.The feedback is that once an OPV program is established, it is not so difficultto maintain, although several find it difficult to integrate into othervalidation activities. A common challenge is how to link the OPV program withthe Product Quality Review reporting. So over the next year we will focus onsharing examples of this within the Process Validation Group. If you have anexample from your company, please share it with us and we will of course keepit neutral and confidential towards the group.

公司实施其OPV计划时相互之间会有很大差异，在过去数年中，ECA关于OPV的课程分享了一些结果良好的公司实施例子。反馈结果显示OPV程序一旦建立，并不难维持，当然会有几家发现难以将其与其它验证活动结合起来。常见的挑战是如何将OPV计划与产品年度审核（PQR）报告链接起来。因此在后续几年我们将专注于在工艺验证组内分享此类案例。如果你公司有这样的例子，请与我们分享，当然我们会将其中性化，并且在组内保密。

Process Validation - the impact of the MRAbetween FDA and EMA

工艺验证---FDA和EMA之间MRA的影响

Later this year it will become clear what the impact ofthe Mutual Recognition Agreement (MRA) between US FDA and EMA will be. Sincethe agreement was announced in March 2017 the work on the implementation hasbeen ongoing and the impact should be clear no later than November 2017 whenthe first European countries are covered by the MRA. In practice it may meanthat most European companies will just follow the principles of Annex 15,whereas global companies will use an approach that fulfills both FDA and EMA requirements.

今年晚些时候，美国FDA和EMA之间的互认协议（MRA）影响将变更明显。由于协议是在2017年3月宣布的，因此实施已经开展，其影响会在2017年11月第一个欧洲国家被MRA覆盖之前显现。在实践中，这可能意味着大多数欧洲国家将只遵守附录15的原则，而全球化公司将使用同时满足FDA和EMA要求的方法。

FDA and the EU inspectorates will use inspection reportsand other related information obtained during drug manufacturing facilityinspections, to help determine whether a facility is manufacturing high qualitydrugs. It is therefore expected that there will be very few European FDAinspections, except in cases where additional information is considerednecessary. So FDA or EU can require further inspections or take other action toprotect the public.

FDA和EU检查人员将使用检查报告和其它对药品生产场所检查期间获得的相关信息来助力于确定一个场所是否生产高质量药品。因此预期FDA对欧洲的检查会非常之少，除非考虑需要其它信息。因此FDA和EU可能会要求进行进一步检查，或采取其它措施来保护公众。

Find out more about ECA´s Validation Group.

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