Key GMP personnel and their duties
Some of the most popular articles on our blog are the four we published some four years ago about key GMP personnel and their duties. These can be found through these links: Part 1 – Production, QC and QP personnel Part 2 – QA personnel Part 3 –...
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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