EMEA Updates Inspection Manual with Reference to ICH Q9

GMP News
9 July 2008

EMEA Updates Inspection Manual with Reference to ICH Q9

The "Compilation of Community Procedures on Inspections and Exchange of Information" could be called EMEA's GMP inspection manual. It includes requirements the EU inspectors should observe when conducting GMP inspections. Its objective is to define harmonised standards for the GMP inspectorates of the different EU countries.

With the publication of ICH Q9 "Quality Risk Management", the European Commission, the EU Member States and EMEA decided that risk management is not only to be implemented by the pharmaceutical enterprises; this principle should also be applied to the inspections conducted by the EU GMP inspectors. For this reason, the EMEA revised the Compilation of Procedures. These requirements have now been in force since April 2008. With regard to Risk Management, you can find among other things:

Risk management
11.3.1 The pharmaceutical inspectorate should implement risk management for assigning
resources and prioritizing tasks and activities to carry out its obligations.( e.g. planning of
11.3.2 The pharmaceutical inspectorate should also implement risk approach in the
conducting of inspection.

Consequently, it is the inspectorates' task to plan the inspections in the individual member states on the basis of the existing resources. The document does not give any details on how this should be done. However, it can be assumed that an approach similar to FDA's risk-based site selection model should be chosen. This model evaluates among other things the company's compliance history as well as the product risk. Sterile products will e. g. certainly be considered more critical than solid dosage forms. It will be interesting to see in how far the inspectors will apply the risk-based approach to the conducting of inspections. Here, too, the text lacks concrete requirements on activities and implementation. Given this lack of details, it is to be feared that the implementation will turn out to be quite heterogeneous in the EU countries. And this would directly contradict the objectives of EMEA's inspection manual. Due to the current discussion about GMP compliance and counterfeit medicines/APIs, which have mainly been found outside the EU, it would be desirable if EU inspectors put the focus on sites above all in the Asian area.

Oliver Schmidt
On behalf of the European Compliance Academy

Source: "Compilation of Community Procedures on Inspections and Exchange of Information"

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