20150319 ECA新闻：2014年修订的相关PIC/S指南文件

20150319 ECA新闻：2014年修订的相关PIC/S指南文件  

2015-03-26 23:35:34|  分类： ECA新闻

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272015226113534893/

GMP News
19/03/2015

Revision of relevant PIC/S Guidance Documents in 2014

2014年修订的相关PIC/S指南文件

Amongst the guidance documents of the European Union and of  the US authorities, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) published the revisions of two relevant guidance documents on blood, plasma or biological medicinal products in January 2014. They became effective on 1 March 2014.

在欧盟和美国药监当局的指南文件中，PIC/S（药品检查协作组织）在2014年1月公布了2份关于血液血浆和生物制品的相关指南。这2份指南于2014年3月1日开始生效。

The first document is the Revised Annex 2  of  the PIC/S GMP Guide  "Manufacture of biological medicinal substances and products for human use". This annex provides guidance on the full range of medicinal substances and products defined as biological.

第一份文件是修订后的PIC/S的GMP指南附录2“人用生物药用物质和药品的生产”。该附录提供关于定义为生物类的药用物质和制剂的全面指南。

The document  is divided into two main parts:

文件被分为2个主要部分：

• Part A contains supplementary guidance on the manufacture of biological medicinal substances and products, from control over seed lots and cell banks or starting material through to finishing activities and testing.
• A部分包括关于生物药用物质和制剂的补充指南，从对种子批和细胞库或起始物料的控制到完成活动和检测
• Part B contains further guidance on selected types of biological medicinal substances and products.
• B部分包括关于生物药用物质和制剂的选择的类型的进一步指南
  

The second document is the Annex 14 "Manufacture of medicinal products derived from human blood or plasma".

第2份文件是附录14“人类血液或血浆衍生的药用制剂”。

Medicinal products derived from human blood or plasma (and their active substances which are used as starting materials) must comply with the principles and guidelines of Good Manufacturing Practice as well as the relevant marketing authorisation. They are considered to be biological medicinal products and the starting materials include biological substances, such as cells or fluids (including blood or plasma) of human origin.

从人类血液或血浆衍生的药品（及其用作起始物料的活性物质）必须符合原则GMP原则和指南要求，以及相关的上市许可要求。它们被认为是生物药品和起始物料，包括生物类物质，例如，细胞或人体组织流体（包括血液或血浆）。

Therefore, following the scope of this Annex:

因此，该附录范围如下

• The provisions of this Annex apply to medicinal products derived from human blood or plasma, fractionated in or imported into the country. The Annex applies also to the starting material (e.g. human plasma) for these products. In line with national legislation the requirements may apply also for stable derivatives of human blood or human plasma (e.g. Albumin) incorporated into medical devices.
• 本附录的条款适用于从人类血液或血浆衍生的药品，分离或出口至国家。附录还适用于这些药品的起始物料（例如人类血浆）。与国家立法相同，要求也适用于稳定的结合进医用器械人类血液或人类血浆制品（例如，白蛋白）
• This Annex defines specific Good Manufacturing Practices (GMP) requirements for collection, processing, storage and transport of human plasma used for fractionation and for the manufacture of medicinal products derived from human blood or plasma.
• 本附录定义了分离用人类血浆收集、处理、存贮和运输，以及人类血液或血浆衍生药品生产特定的GMP要求
• The Annex addresses specific provisions for when starting material is imported from other countries and for contract fractionation programs for other countries.
• 附录说明了当起始物料从其它国家进口时以及用于其它国家合同分离计划时的特定条款
• The Annex does not apply to blood components intended for transfusion.
• 附录不适用于输血用血液成分
  

The complete Annexes can be found at the PIC/S Website.

完整附录可以在PIC/S网站上找到。