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the European Commission has published the final Chapter 8 of the EU Guidelines for GMP (Complaints, Quality Defects and Product Recalls). The chapter has been revised completely. Whereas the current one has less than two pages focusing on complaints and recalls 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
Throughout its chapters, the new version of Chapter 8 introduces Quality Risk Management principles and appropriate root cause analysis work when investigating quality defects and complaints. The scope includes complaints including quality defects (this is also new) and recall issues with respect to marketed medicinal products and investigational medicinal products (IMPs) that have been released to clinical…
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