Update to EU GMP Chapter 2 – Personnel
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...
Routes of administration of medicines
A crude way of looking at how we get medicines into the body is this – “if there’s a hole then we’ll put medicines in it and if there is not a hole, then we’ll go and make one”! The intake of medicines is achieved either via absorption or direct injection. With...
The positioning of the Qualified Person (QP) within the organisation
In previous posts we have looked at the Roles and Responsibilities of the 3 Key Personnel required by EU GMP, namely the Head of Production, the Head of Quality Control (QC) and the Qualified Person (QP). In this post we look at the organisation of these people...
Duties of key personnel in GMP – Part 3 (Engineering)
From Parts 1 and 2 of this post we highlighted that there is no formal need for an Engineering Manager or Department in GMP. In the manufacture of medicines the equipment used and the environment it is located in has a massive impact on product quality. The role of...About Inspired Pharma
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