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标题: 20150218 ECA新闻：EU GMP指南第1部分第8章新旧对比（2015年3月1日生效） [打印本页]

作者: xiaoxiao 时间: 2015-2-27 08:27 PM
标题: 20150218 ECA新闻：EU GMP指南第1部分第8章新旧对比（2015年3月1日生效）
20150218 ECA新闻：EU GMP指南第1部分第8章新旧对比（2015年3月1日生效）

2015-02-27 20:07:04| 分类： ECA新闻

GMP News
18/02/2015

Matrix compares old vs new EU GMP Guide Part I, Chapter 8 - effective as of 1 March 2015

EU GMP指南第1部分第8章新旧对比（2015年3月1日生效）

Starting with the 1 March 2015 the revised EU GMP Guide Part I, Chapter 8 (Complaints, Quality Defects and Product Recall) becomes effective (see also our GMP News from 23 September 2014). Until then the version with the validity date 1 February 2006 is still applicable.

自2015年3月1日起，修订后EU GMP指南第1部分第8章（客诉、质量缺陷和产品召回）将生效（参见我们2014年9月23日的GMP新闻）。此前2006年2月1日的旧版仍为有效。

The following matrix provides you with a compact overview of the changes. It allows you to quickly compare it with an existing QM system and can thus be used for a "GAP" analysis, a self inspection or for audits.

以下交叉对照表提供了变更的概览。通过它，你可以对现有QM体系进行快速对照，从而用于差距分析、自检或审计。

EU GMP Guide Part I, Chapter 8 Version effective as of 1 March 2015 (new version)	EU GMP Guide Part I, Chapter 8 Version effective until 28 Feb. 2015 (old version)
Principles (supplemented by: - QRM requirements - Reference to chapter 1 - Reference to competent authority - Reference to chapter 7)	Principles
Personnel and Organisation	-
8.1 (supplemented by: - Independence of Marketing and sales - Emphasizing Training)	8.1
8.2	-
8.3	-
8.4	-
Procedures for handling investigations of complaints including quality defects	Complaints
8.5	8.2 (partly)
8.6 (supplemented by: - Special focus on falsification)	8.7
8.7	-
8.8 (supplemented by: - Focus on adverse event)	Comparable to 8.4
8.9 (supplemented by: - Investigation procedures described in detail, e.g. CAPA)	Comparable to 8.2
Investigation and decision making	-
8.10 (supplemented by: - QRM requirements - QC not mentioned any longer)	8.3/8.5
8.11 (Rework not mentioned any longer)	8.4
8.12	Comparable to 8.6
8.13	-
8.14 (supplemented by: - Early phases of investigation - Decision making process - Risk reducing actions)	Partly 8.5
8.15 (Counterfeits not mentioned)	8.7
Root Cause analysis and CAPA	-
8.16	-
8.17	-
8.18 (supplemented by - CAPA and effectiveness monitoring and assesment)	Comparable to 8.6
8.19 (supplemented by: - Trending)	Comparable to 8.6
Product recalls and other potential risk reducing measures	Recalls
8.20 (supplemented by: - Risk reducing actions)	8.10
8.21	-
8.22 (supplemented by: - Recalls prior to a root cause analysis)	8.11
8.23	8.13
8.24	-
8.25 (supplemented by: - Scope of recall regarding the distribution network - Missing recall due to short shelf-life products)	8.12
8.26 (supplemented by: - Need for recall prior to information of authority - Cooperation with competent authority)	8.12
8.27	-
8.28 (supplemented by: - Details regarding Rework)	8.14
8.29	8.15
8.30 (supplemented by: - Mock recall)	8.16
8.31	-

QRM: Quality Risk Management, QC: Quality Control, CAPA Corrective And Preventive Action

EU GMP指南第1部分第8章 2015年3月1日生效版本（新版）	EU GMP指南第1部分第8章 2015年2月28日前有效版本（旧版）
原则增加 - QRM要求 - 对第1章的引用 - 对药监机构的引用 - 对第7章的引用	原则
人员和组织结构	-
8.1 增加 - 市场和销售的独立性 - 强调培训	8.1
8.2	-
8.3	-
8.4	-
处理客诉投诉包括质量缺陷的程序	客诉
8.5	8.2 (partly)
8.6 增加 - 伪药的特殊关注	8.7
8.7	-
8.8 增加 - 对不良反应事件的关注	与8.4可比
8.9 增加 - 调查程序的详细描述，例如CAPA	与8.2可比
调查和做出决定
8.10 增加 - QRM要求 - QC没再提到	8.3/8.5
8.11 再加工没再提到	8.4
8.12	与8.6可比
8.13	-
8.14 增加 - 调查的早期阶段 - 做出决定的过程 - 降低风险的行动	部分在8.5中
8.15 没有提到伪药	8.7
根本原因分析和CAPA
8.16	-
8.17	-
8.18 增加 - CAPA和有效性监控和评估	与8.6可比
8.19 增加 - 趋势	与8.6可比
产品召回和其它潜在降低风险的措施	召回
8.20 增加 - 降低风险的行为	8.10
8.21	-
8.22 增加 - 在根源原因分析前的召回	8.11
8.23	8.13
8.24	-
8.25 增加 - 销售系统内的召回范围 - 由于较短的货架期产品使得召回不能实现	8.12
8.26 增加 - 在通知药监机构之前有即进行召回的需要 - 与药监机构合作	8.12
8.27	-
8.28 增加 - 关于再加工的细节	8.14
8.29	8.15
8.30 增加 - 模拟召回	8.16
8.31	-

QRM：质量风险管理，QC质量控制，CAPA纠正和预防措施

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201512623631927/

作者: feibing 时间: 2015-3-7 11:03 PM
好资料，好好学习

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