ECA组织及其利益团欧洲QP协会对EU GMP附录1的修订提出建议

20150429 ECA新闻：ECA组织及其利益团欧洲QP协会对EUGMP附录1的修订提出建议  

2015-04-2923:44:03|  分类： ECA新闻

GMP News
29/04/2015

ECA Foundation and its Interest Group European QPAssociation comment on EU GMP Annex 1 Revision

ECA组织及其利益团欧洲QP协会对EU GMP附录1的修订提出建议

In February 2015 the European Commission published aConcept Paper with the intent to revise the EU GMP Annex 1 on sterilemanufacturing. The time frame provided by the EU Commission is verysmall.  End of March 2015 has been set as deadline for industry commentsand in October 2015 a draft version of the revised EU GMP Annex 1 is planned tobe published.

在2015年2月，欧洲委员会公布了其将修订EU GMP附录1 无菌生产的概念文件。EU委员会所提出的时间框架非常短。2015年3月底是行业建议的最后期限，计划在2015年10月公布该附录1的草案。

The ECA Foundation andits Interest Group, the European QP Association (EQPA),are Europe?s leading interest Groups in the area of pharmaceutical QualityAssurance and GMP Compliance. Because of the importance of the document ECA andEQPA decided to form an expert working group with members from differentpharmaceutical companies and independent experts under the leadership of ECA?s Chairman Richard M. Bonner.Although the time frame provided was very small the ECA /EQPA managed tosummarize the feedback provided by the expert group members by 31 March 2015.

ECA组织和其利益团队，欧洲QP协会（EQPA），是欧洲药品质量保证和GMP符合性领域中领先的利益团队。由于文件非常重要，ECA和EQPA决定组成一个专家工作组，其成员来自不同制药公司和独立的专家，由ECA主席RICHARD M.BONNER领导。尽管所提供的时间很短，CEA/EQPA还是将专家组成员在2015年3月31日之前所提供的反馈意见进行了总结。

The ECA/EQPA Expert Working Group generally welcomes theintention of the EU Commission to revise the EU GMP Annex 1. Since the currentversion was published in 2008 a number of new technologies have beenimplemented and challenges have been observed which should be reflected in therevision process. Isolator Technology and especially RABS systems have beenintroduced in various technical versions in many companies. Currently there isno definition what requirements RABS systems should fulfill, and there is noexact definition for a RABS system either. One of many other topics refers tomore details on airlocks (e.g. is it possible to skip one grade betweenmaterial/equipment airlocks?). It might also be useful to add at least the twonew classes E and F.

ECA/EQPA专家工作组欢迎EU委员会对EU GMP附录1进行修订。自从现行版本在2008年公布以来，已有很多新技术被实施，已观察的挑战应在修订中反映。分离器技术，尤其是RABS系统在很多公司以不同技术版本被引入。现在，对RABS系统应满足的要求还没有界定，对RABS系统也没有确切的定义。其它许多问题中还一个是缓冲的问题（例如，是否可能在物料/设备缓冲中跳过一个洁净级别）。至少增加2个新的级别E和F也可能会有帮助。

Harmonisation of standards is an important goal for arevised Annex 1 as well. The requirements laid down in ISO 14644-1 (ISO5)should be considered, e.g. when it comes to monitoring performed for 0.5 ?mparticles. In addition, changing the 5.0 micron particle limit for grade A toalign with ISO 5 (29/m3) might be considered in a new Annex 1. Harmonisationshould also be made with the FDA Aseptic Guide to allow companies to meet thesame requirements.

修订的附录一中标准的统一也是一个很重要的目标。应考虑在ISO14644-1（ISO5）中所定义的要求，例如，在对0.5?m尘粒进行监控时。另外，在新的附录1中可能会考虑对A级中5.0 ?m粒子的限度进行变更以与ISO5（29/m3）保持一致。与FDA无菌指南的一致性也应该考虑，这样让公司能符合相同的要求。

The EU Commission announced in their Concept Paper on therevision of Annex 1 that Quality Risk Management (ICH Q9) shouldbe applied. A potential application is the monitoring program. A Monitoringprogram in classified areas in general, not only Grade C or D, should beperformed in accordance with Quality risk management. Other concepts likeinvestigations, sanitisation, etc. should reflect this concept.

EU委员会在其概念文件中宣布要应用质量风险管理（ICH Q9）。一个潜在的应用即是在监控程序中。在洁净区里的监控程序一般来说，不仅是C级或D级，均应符合质量风险管理。其它概念如调查、消毒等应反映该概念。

One of the most intensively discussed requirements in thecurrent Annex 1 is the wording "Grade A airsupply". According to the current EU GMP Annex 1"stoppered vials should be protected with a Grade A air supply until thecap has been crimped." However, Grade A air supply is not defined andclarification is necessary in the new version.

在现行附录1的要求中被广泛讨论的一个问题是“A级空气供应”的用词。根据现行EU GMP附录1“瓶加塞应受到A级空气送风保护，直到瓶盖被轧好”。但是，A级空气送风并没有定义，在新版中应进行澄清。

Many other aspects have been summarised by the ECA/EQPAExpert Working Group. Once the EU Commission will publish the comments we willprovide a link to the detailed comments on the ECA webpage.

还有很多其它方面忆经由ECA/EQPA专家工作组总结。一旦EU委员会公布其建议，我们将在ECA网页上提供一个详细建议的链接。

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201532911443328/