A new update to EU GMP Chapter 2 has been issued and comes into operation on 16th February 2014. Here is a summary of the main changes from the previous version Chapter 2 Personnel OLD. A copy of the new version can be found by clicking on the link Chapter 2...
At some point every year (or perhaps every 2 years) someone in a pharmaceutical organisation will say “It’s time to think about this year’s GMP training”. This statement will usually be received with little enthusiasm from those who hear it,...
From Parts 1, 2 and 3 of this post we have focused on the duties of the three key personnel named in EU GMP (the Head of Production, QC and the Qualified Person). We have also highlighted that there is no formal requirement for an Engineering Manager (or Department)...
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