Matrix compares old vs new EU GMP Guide Part I, Chapter 8 - effective as of 1 March 2015
Recommendation
27/28 May 2025
Supervision of the Pharmaceutical Quality System: Challenges and Opportunities
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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 | 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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