Revision of Chapter 8 of the EC guide to GMP

The European Medicines Agency (EMA) GMDP Inspectors Working Group has agreed on a concept paper on revising chapter 8 'Complaints and Product Recall' of the EC guide. The Working Group recommends that the current 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 scope includes complaint and recall issues with respect to marketed medicinal products and investigational medicinal products (IMPs) that have been released to clinical trials. The Working Group also proposes to better reflect the wording of Directive 2003/94/EC 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.

Besides investigating and determining the cause(s) of quality defects/complaints, a revised chapter 8 should also ensure that appropriate preventative actions are put in place to avoid recurrence of the issue. CAPA has already been introduced in the revision of chapter 1 and should now also be recognised in chapter 8.

Overall, the goal is to achieve information-based and scientific decisions in relation to risk-mitigating actions. It should also be highlighted that there may be more than one cause associated with a quality defect/complaint. However all likely causes should be thoroughly investigated leading to more effective preventative actions being identified and put in place.

When it comes to product recalls, it should be recognised that the current chapter makes no reference to communication tools which are available to mitigate risk. Also, the current guidance does not incorporate much, if any, 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.

While the current guidance does require that the Qualified Person (QP) who certified the batch is made aware of any complaint, investigation or recall it needs to be emphasised that full details of any investigation must be available to the QP so that the impact for any batches on the market or future supply to the market can be properly evaluated. The details relating to any investigation must also be made available to the Competent Authorities as required. The Working Groups now recommend that the revision of chapter 8 should include a requirement that all details which are relevant to an investigation should be available to the QP responsible for certification for release.

The deadline for comments on this Concept Paper is June 2011 and the envisaged preparation of revised guidance is planned for May 2011 - September 2011.

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)