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:
11.3.1 The pharmaceutical inspectorate should implement risk management for
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
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.
On behalf of the European Compliance Academy
"Compilation of Community Procedures on Inspections and Exchange of Information"