IGMPI India

The European Commission has published the final Chapter 8 of the EU Guidelines for GMP (Complaints, Quality Defects and Product Recalls). The chapter has been amended completely and hence providing a completely new chapter compared to the current version that addresses only Complaints & Recalls.'Pervasive changes have been made to this Chapter which now reflect that Quality Risk Management principles should be applied when investigating quality defects or complaints and when making decisions in relation to product recalls or other risk-mitigating actions' EU says.

The revised version formalizesthe expectations for:
•  Personnel and Organization
•  Procedures for handling and investigating complaints including possible quality defects
•  Investigation and Decision Making
•  Root Cause Analysis and Corrective and Preventative Actions
•  Product Recalls and other potential risk-reducing actions


The new version of Chapter 8requires the implementation of Quality Risk Management principles and appropriate root cause analysis when investigating quality defects and complaints. The scope covers Complaints, Quality Defects (a new concept in the revision) and Recall issues with respect to marketed medicinal products and investigational medicinal products (IMPs) that have been released to clinical trials.

The revised chapter details the explicitrequirements for written procedures like SOPs. They should at least address the following:
•  The description of the reported quality defect.
•  The determination of the extent of the quality defect.
•  Handling of samples
•  The assessment of the risk(s) posed by the quality defect.
•  How decisions and assessments are made
•  Notification to the relevant authorities and other internal and external communications
•  Root cause analysis and CAPAs.


The role of the Qualified Person (QP) in the certification for release of the concerned product is also emphasized.

When it comes to product recalls, the new chapter also addresses risk diminution and risk-based thinking into the recall decision-making process.In this context, the Manufacturer and Marketing Authorization Holder shall ensure continuity of supply for critical medicinal products where alternative products may not be readily available.

This revision also provides further clarity with respect to Mock Recalls.

Overall, the goal is to achieve information-based and scientific decisions in relation to risk-mitigating actions. However all likely causes should be comprehensively investigated leading to more adequate preventative actions being identified and put in place.