Update to EU GMP Chapter 1 – Pharmaceutical Quality System

After a longer period of review and many draft versions published 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.

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 within the business.  It is in the spirit of GMP that these roles are taken by people who are permanent employees of the organisation in full-time roles (EU GMP Chapter 2.3), but does that mean you need to employ three different individuals?  Can, for example, you be the Head of QC and also be the Qualified Person?  This article looks into this.

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) AND a Quality Assurance Manager (or Department) in GMP.  Most pharmaceutical manufacturing sites do actually have these people (and departments) and we have looked at the roles and responsibilities commonly performed by these in previous posts.  There is also a final “key personnel” not named in GMP, namely the Human Resources Manager.  Bearing in mind that in the manufacture and testing of medicines it is the employees themselves who have a massive impact on product quality and the quality system then the importance of the individual who looks after employees (usually the HR Manager) cannot be understated.

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 the Engineering Manager is therefore critical.  In a number of engineering related GMP courses that I have presented in the past we have looked at what the delegates think the Head of Engineering’s role should be, bearing in mind the role is not defined in EU GMP.  Some of the roles already assigned in GMP to the Head of Production can be delegated to them, with additional roles added as well.  Their findings are below:

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 we have looked at what the delegates think QA’s role should be, bearing in mind the role is not defined in GMP.  Roles already assigned in GMP to the Head of QC and the QP can be delegated to QA, with additional roles added as well. Their findings are below: