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...
Duties of key personnel in GMP – Part 2 (Quality Assurance)
From Part 1 of this post we highlighted that there is no formal need for a QA Manager or Department in GMP. EU GMP does require you to have a QA system, but there is no mention of who should manage the system. In a number of courses that I have presented in the past...
Duties of key personnel in GMP – Part 1 (Production, QC and the QP)
Duties of key personnel in GMP – Part 1 (Production, QC and the QP)Three key personnel are named on a pharmaceutical manufacturing site’s Manufacturing Licence. These are the Head of Production, the Head of Quality Control and the Qualified Person(s). Their roles...
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