June 2019/1 Summary IgJ GMP Inspection data 2018.

In this blog I would like to share some of the results from the analyses of the EU GMP data as reported by the Dutch inspectorate IgJ in 2018. In fig. 1, you can find an overview of the number of observations / EU GMP Chapter or Annex including a breakdown of the distribution of the observation ratings (i.e. critical, major and other).

Fig.1 # Observations / EU GMP Chapter or Annex

Fig. 2 displays the results of the analyses one level deeper and provides insight in the distribution of the critical and major observations over the individual Sections or Annexes of the EU-GMPs. From these results it can be derived that the critical and major observations were (mostly) related to Section 1.4 and Annex 16 of the EU-GMPs.

Fig.2 Distribution of Critical & Major observations / EU GMP Section or Annex

STAY TUNED THERE IS MORE TO COME……