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. The revision is 6 pages long (vs 2 pages in the original one). The new version defines 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
The new version introduces Quality Risk Management and proper root cause analysis for investigating quality defects and complaints. Also new is that the scope now includes quality defects and recall issues with respect to marketed medicinal products and investigational medicinal products (IMPs) that have been released to clinical trials. Moreover, the wording of the new version is better aligned with the wording of Directive 2003/94/EC with regard to when a quality defect/complaint should be reported to the competent authority.
Also new is that CAPAs are introduced and mentioned in order to prevent the issue from hapening again. The effectiveness “should be monitored and assessed”.
The new version clearly states that a written procedure should be available and also states what it should at least contain:
- 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.
Another important addition to the new chapter is that the so called Mock Recalls are 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. ”
The new version will become effective on March 1st 2015