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标题: ECA新闻20150512：ECA和PQG公布EU GDP第6章解读 [打印本页]

作者: 淡定 时间: 2015-5-23 01:19 PM
标题: ECA新闻20150512：ECA和PQG公布EU GDP第6章解读
ECA新闻20150512：ECA和PQG公布EU GDP第6章解读

2015-05-13 21:19:22

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GMP News
12/05/2015

ECA and PQG publish Chapter 6 of the interpretation of the EU GDP Guideline

ECA和PQG公布EU GDP第6章解读

The ECA Foundation and the Pharmaceutical Quality Group (PQG) have been working on the interpretation of different chapters of the EU GDP Guideline. The interpretation of five chapters have been published already. The following 5 Guidance chapters on the EU GDP Guideline are available:

ECA组织和药品质量组（PQG）经着手在制订EU GDP指南不同章节的诠释。以下五章的解读已经公布：

Chapter 1: Quality Management
Chapter 9: Transportation (also contains a template for a Technical Agreement)
Chapter 7: Outsourced Activities
Chapter 2: Personnel
Chapter 5: Operations

第1章：质量管理

第9章：运输（还包括技术协议的模板）

第7章：外包活动

第2章：人员

第5章：运营

Now the group has finalized the work on chapter 6 - Complaints, Returns, Suspected Falsified Medicinal Products & Medicinal Product Recalls. Chapter 6 of the EU GDP Guideline requires that all complaints, returns, suspected falsified medicinal products and recalls must be recorded and handled carefully according to written procedures. Some returned medicinal products might be released for resale. The handling should be performed only after an assessment of the returned medicinal products. The approval should be made by the Responsible Person (RP). Also complaints must be handled based on a written procedure and all details of each complaint must be recorded. Finally, the identification and handling of Falisified Medicinal Products are also defined in chapter 6. The ECA/PQG Guidance document provides information on how to implement the requirements.

现在药品质量组已经完成了对第6章—投诉、退货、疑似假药和医疗产品召回的解读制订工作。EU GDP指南的第6章要求所有投诉、退货、疑似假药和召回必须根据书面程序进行记录和处理。有些退回的药品可以再次放行销售。只有在对退回的药品进行评估后才可以进行处理。必须由负责人（RP）进行批准。投诉也必须根据书面程序进行处理，每个投诉的所有细节都必须记录。最后，假药的辨识和处理也在第6章进行了定义。ECA/PQG指南文件提供了如何实施这些要求的信息。

You will find chapter 6 and all other GDP Guidance chapters in the members area of the GDP Group Webpage. Membership is available at no costs.

作者: ruichao2005 时间: 2015-5-23 07:50 PM
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