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

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.

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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