Already in early 2011, the European Medicines Agency (EMA) GMDP Inspectors Working Group has agreed upon a concept paper on revising chapter 8 'Complaints and Product Recall' of the EC guide. The Working Group recommended that the new version of Chapter 8 should introduce Quality Risk Management principles and appropriate root cause analysis work to be applied when investigating quality defects/complaints. The Working Group also proposed to better reflect the wording of Directive 2003/94/EC on when a quality defect/complaint should be reported to the competent authority and to consider the risk-based classification system for quality defects that is contained within the Compilation of Community Procedures.
Now, the European Commission DG Health & Consumers has published the revised chapter 8 on Complaints, Quality Defects and Product Recalls. The chapter has been revised completely. Whereas the current one has less than two pages focussing on complaints and recall only, the revision is six pages long, defining 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
Quality Risk Management now plays an important role in the revised chapter and the "principles should be applied to the investigation and assessment of quality defects and to the decision-making process in relation to product recalls and other risk-reducing actions". In the case of a quality defect which "may result in the recall of the product or an abnormal restriction in the supply", all competent authorities concerned should be informed.
The Qualified Person (QP) who is involved in the certification for release of the concerned product will play an important role. If 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". For all respective actions like for example handling, reviewing and investigating complaints, sufficient personnel and resources should be made available.
The revised chapter details the requirements 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.
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.
So called Mock Recalls are now also described in more detail. Evaluations of the effectiveness "should extend to both within office-hour situations as well as out-of-office hour situations and, when performing such evaluations, consideration should be given as to whether mock-recall actions should be performed. This evaluation should be documented and justified. "
Source: Revision document
Comments and suggestions are invited by 18 July 2013 and should be sent by email to: ADM-GMDP@ema.europa.eu and SANCO-pharmaceuticals-D6@ec.europa.eu