18.02.2015

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

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

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	-