by Dominic Parry | May 1, 2019
The video in this article is part of a unit in our online QMS courses (see below) that looks at how to implement a Quality Management System and, in this video, we look at “The roles of the Heads of Production & QC and the Qualified Person” and what GMP’s...
by Dominic Parry | Apr 24, 2012
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...
by Dominic Parry | Apr 20, 2012
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)...
by Dominic Parry | Apr 17, 2012
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...
by Dominic Parry | Apr 10, 2012
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...
by Dominic Parry | Apr 3, 2012
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...