ECA新闻：ECA公布规范准则：GDP负责人

julia朱玉姣

GMP News
09/03/2016

ECA publishes Code of Practice: TheResponsible Person for GDP

ECA公布规范准则：GDP负责人

A Task Force initiated by the ECA Foundation hasdevelopend a Guidance document which aims to support Responsible Persons (RPs) forGood Distribution Practice (GDP). The EU Guide to Good Distribution Practice(2013/C 343/01) has defined a number of new requirements when it was publishedin 2013.

ECA组织发起的一个任务组制订了一份指南文件，其目的是支持优良销售规范（GDP）负责人（RP）。EU的GDP指南 (2013/C 343/01)于2013年公布，其中定义了大量新的要求。

In Chapter 2 Personnel the GDP Guide definesrequirements, responsibilities and duties of RPs. But what is expected and howcan RPs show compliance with the requirements? For example the Guide defines,that "the RP should meet the qualifications and all conditions providedfor by the legislation of the Member State concerned" or "The responsibleperson should fulfil their responsibilities personally and should becontinuously contactable."

在GDP指南的第2章人员中，定义了RP的要求、职责和义务。但是，期望是什么，RP如何能证明符合要求呢？例如，指南中定义“RP应满足成员国立法中定义的资质要求和所有条件”以及“负责人应亲自履行其职责，应保持随时可以联系到。”

Here the Code of Practice provides information forinterpretation. One section of the document provides a matrix ofresponsibilities for RPs, Senior Management and Authority for certain topicsaddressed in the EU GDP Guideline. Information is also provided for:

这里规范准则提供了一些诠释信息。文件的一个部分提供了RP职责矩阵表，高级管理人员和官方在EU GDP指南里特定主题中均有说明。以下也是一些有用的信息：

• External Responsible Person (Contract RPs)
• 外部负责人（合同RP）
• Organisational Duties to be established by the company employing the     RP
• 由公司雇佣RP来建立公司的义务
• Educational Background and ongoing Training for RPs
• RP有教育背景和持续培训
• and basic information to design a Job Description for RPs
• 有基础信息来设计RP的岗位职责
  

The Code of Practice Version 01 is available on the ECA GDP Group Webpage. Thedocument is available at no costs after registration.

规范准则第01版本在上述网址可以找到，是免费的但需要先注册。

yuansoul

这次小龙族 经济水平就不用担心了。有负责人了。

大呆子

ECA是什么缩写？

RP相当制药的QP吧？

zysx01234

没有意思

枫子

优良销售规范（GDP）负责人（RP），责任重大，销售过程不确定因素太多

chenjiao501

大呆子 发表于 2016-3-10 08:02
ECA是什么缩写？

RP相当制药的QP吧？

ECA:European Compliance Academy 欧洲符合性协会

北重楼

这个要求是越来越高了