Summary IgJ inspection data 2016

Recently the Dutch Health Authority Inspectie Gezondheidszorg en Jeugd (IgJ) has started to publish the results from their GMP/GDP oversight program in the public domain (click HERE) just like the FDA has been doing for already quite some time. Not only do these results provide more detailed insight in the GMP/GDP inspection program itself, but it also is a useful resource to gain a better understanding of the expectations of the inspectorate and to identify trends on most cited observations. Below you will find some key figures that I have derived from the GMP and GDP inspection reports of IgJ as issued to companies / wholesalers in 2016.

Figure 1 | Summary - 2016 IgJ GMP inspection data.

Figure 2 | Summary - 2016 IgJ GDP inspection data.

A similar database is maintained for the FDA information and has been successfully deployed in the preparation of FDA inspections in the past two years.

Stay tuned, there is more to come…