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.
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
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