The European Commission DG Health & Consumers has published the new EU-GMP 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 also details additional requirements for recalling investigational medicinal products (IMPs). Chapter 8.24 says that "In the case of investigational medicinal products, all trial sites should be identified and the countries of destination should be indicated. In the case of an investigational medicinal product for which a marketing authorisation has been issued, the manufacturer of the investigational medicinal product should, in cooperation with the sponsor, inform the marketing authorisation holder of any quality defect that could be related to the authorised medicinal product. The sponsor should implement a procedure for the rapid unblinding of blinded products, where this is necessary for a prompt recall. The sponsor should ensure that the procedure discloses the identity of the blinded product only in so far as is necessary."