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 | 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
Related GMP News
26.06.202410 points on how the FDA's CDER monitors the Quality of Medicinal Products
08.05.2024EMA Plans for the next three Years
30.04.2024Lean GMP: is "right-sizing" GMP and Compliance possible?
24.04.2024Unexpected Deviations: the Role of the QP
10.04.2024FDA's current Thinking on KPIs and Quality Metrics
21.02.2024What is the African Medicines Agency?