Complaints and Recalls: New EU-GMP Chapter 8 published - 17 Sep 2014
The European Commission has published the final Chapter 8 of the EU Guidelines for GMP(Complaints, Quality Defects and Product Recalls) and hence providing a completely new chapter compared to the current version that addresses only Complaints & Recalls. The Commission provides the reasons for change thus:
“Extensive 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. It emphasises the need for the cause(s) of quality defects or complaints to be investigated and determined, and that appropriate preventative actions are put in place to guard against a recurrence of the issue and clarifies expectations and responsibilities in relation to the reporting of quality defects to the Competent Authorities”.
The revised version clarifies the expectations for:
- Personnel and Organisation
- 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 revised Chapter 8 requires 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.
In addition, there is emphasis on investigating and determining the cause(s) of quality defects/complaints, and ensuring that appropriate corrective and preventative actions are put in place to avoid recurrence and the effectiveness "should be monitored and assessed".
When it comes to product recalls, the new chapter also addresses risk mitigation and risk-based thinking into the recall decision-making process. In this context, the Manufacturer and Marketing Authorisation Holder shall ensure continuity of supply for critical medicinal products where alternative products may not be readily available. Consultation with the Competent Authority is therefore inevitable.
The role of the Qualified Person (QP) in the certification for release of the concerned product is also emphasised. Where the QP is not directly responsible for managing complaint and quality defect investigations and for deciding the measures to be taken, he or she "should be made formally aware of any investigations, any risk-reducing actions and any recall operations, in a timely manner". In addition, there must be sufficient personnel and resources to address all actions for handling, reviewing and investigating complaints.
With this new revised chapter, there is also an explicit requirement for written procedures (SOPs) and this 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
- The decision making process with respect to risk mitigation
- Notification to the relevant authorities and other internal and external communications
- Root cause analysis and CAPAs
There should also be established written procedures in relation to recall activities or the implementation of any other risk-reducing actions, so that recall operations can be initiated promptly and at any time.
Paragraph 30 of the revised chapter provides further clarity with respect to Mock Recalls. In principle, evaluations of the effectiveness of the recall process "should extend to both within office-hour situations as well as out-of-office hour situations”. Such evaluations on the need for a mock should be documented and justified.