Update to EU GMP Chapter 1 – Pharmaceutical Quality System
After a longer period of review and many draft versions the final update to EU GMP Chapter 1 on “Quality Management” comes into operation on 31st January 2013. Here is a summary of the main changes. Title change: The title of the chapter has changed from “Quality...
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 4 (Human Resources)
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)...
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...
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