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【ECA 新闻】WHO技术报告-生物产品GMP修订

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译文:Levi/Avril 校对:Ella


The World Health Organization (WHO) provides a Technical Report Series on their website with guidancedocuments comprising general recommendations for biological products.

世界卫生组织(WHO)在其网站发布了关于生物产品的技术报告系列以及一般建议的指南文件。

Thecurrent document "Good Manufacturing Practices for biological products;Adopted 1991, TRS no 822, Annex 1" is now supposed to be revised. Thus theExpert Committee on Biological Products published a proposed replacement ofthis document. This draft was developed based on the outcomes and consensus ofthe WHO informal consultation convened in July 2014 with participants from nationalregulatory authorities, national control laboratories, manufacturers and academiaresearchers. It is furthermore supposed to include comments from the publicconsultation on the WHO website. Additional comments can be submitted to theWHO until 14 September 2015.

目前计划对现行的文件“生物制品的生产质量管理规范,发布于1991年,技术报告822,附录1”进行修订。因此,生物制品委员会发布了该文件提议的替代文件。该草案的开发是基于WHO20147月和国家监管部门、国家控制实验室、厂家和研究人员参与的非正式会议的结果和共识。除此之外,还包括来自WHO网站上的公共咨询的意见。在2015914日前可以向WHO提供其他的意见。

Thedocument is supposed to serve as a basis and reference/guide for the generationof appropriate/suitable national guidelines. Possibly there will bemodifications/changes necessary in comparison with this document, based on arisk/benefit assessment and legal considerations of the respective nationalauthority.

该文件可以作为出台适当的/合适国家指导方针的基础和参考/指南。基于风险/利益评估和各自国家机构和法规方面的考虑,和本文件相比可能会有必要的修订/修改。

The scope of this guidance document is defined as follows:
本指南文件的范围定义如下:

"Theseguidelines apply to the commercial manufacture, control and testing ofbiological products from starting materials and preparations, including seedlots, cell banks and intermediates, through to the finished products.Manufacturing procedures within the scope of these guidelines include:

“这些指导原则适用于生物制品商业生产、控制和检测,从起始物料和制剂,包括批原料、细胞库和中间产品,一直到成品。在这些指导原则中的生产工艺包括:

  • growth of strains of microorganisms and eukaryotic cells

  • 微生物菌株和真核细胞的增殖

  • extraction of substances from biological tissues, including human, animal and plant tissues and fungi

  • 从生物组织中提取的物质,包括人类、动物和植物组织以及真菌

  • recombinant DNA (rDNA) techniques

  • DNA重组技术

  • hybridoma techniques and

  • 杂交细胞技术

  • propagation of microorganisms in embryos or animals"

  • 微生物在胚胎或动物上的增殖

The complete text and contact data for thesubmission of comments can be found at WHOGMP for Biological Products - Proposed replacement of: TRS 822, Annex 1.

完整的文本和提交评论的相关数据可以在WHO GMP for Biological Products - Proposed replacement of: TRS 822,Annex 1找到。



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