EC guide to GMP, Ch 8 (Complaints and Recalls)


This is a chapter of EU GMP dealing with that part of the PQS where the results of our assessments are put to the patients.

This may sound quite dramatic but any PQS should be designed with quality, safety and efficacy in mind which is ultimately judged at the patient interface.  In the case of complaints, defects and the possibility or execution of a recall the PQS is challenged and the ‘quality’ of our investigations and subsequent decisions are of paramount importance.

As companies grow and the definition of global extends beyond companies with offices in both the US and Europe; the complexity of this topic increases.

Multi market complaint assessment and much more hierarchical and multi country leadership has to be managed effectively so as to ensure the primary goal of patient safety does not suffer from protracted or disparate decision making.

The update to this chapter reaffirms the need for multidisciplinary decision making yet still ensures the Qualified Person is not marginalized in the actual decision making process.

Some points of interest:

  • Quality Risk Management continues to be reflected in all guidance documents
  • Quality defect guidance expanded with more prescriptive guidance.

How can you help your fellow members?

  • We all work within different PQS so with this in mind, how does your PQS account for these important topics?  Could the EU guidance benefit from your experience?  I would say yes!
  • Does the guidance go far enough? How do you think this guidance fits in with existing guidance or planned updates to other chapters?
  • This ‘guidance’ will soon need to be implemented and inspected.  Can you suggest revisions to the draft before this happens?  This is your opportunity.

To open the revised chapter, please click HERE

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