The European Medicines Agency (EMA) has issued the latest in a series of consultations on various aspects of revision of the EU Guidelines on Good Manufacturing Practice (GMP) for medicinal products. The new consultation is a concept paper on revisions to Chapter 8 of the GMP Guidelines on Complaints and Product Recall.
Among the proposals for comment in the paper are:
- A recommendation that the current version of Chapter 8 be revised to introduce the need for Quality Risk Management principles and appropriate root cause analysis work to be applied when investigating quality defects/complaints and when making decisions in relation to product recalls or other risk-mitigating marketplace actions.
- A recommendation that the current Chapter 8 wording in relation to when a quality defect should be reported to the Competent Authority should be revised to more accurately reflect the wording of Directives 91/412/EEC and 2003/94/EC
- A proposal that the relative responsibilities of the manufacturer and Marketing Authorisation Holder are clarified in relation to ensuring continuity of supply. This is particularly relevant for critical medicinal products where alternative products may not be readily available
EMA states that the scope of the proposal includes quality defect/complaint and recall issues with respect to marketed medicinal products and investigational medicinal products (IMPs) that have been released to clinical trials. The paper notes that while recalls of IMPs are addressed in Annex 13, there is little or no reference to the investigation of quality defects and complaints in Annex 13.
The concept paper is open for comment until 30 June 2011 and the proposed timetable envisages release for comment of a draft revision of Chapter 8 early next year and this column will revisit the issue when it is available.