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Posts tagged ‘QA’

Update to EU GMP Chapter 1 – Pharmaceutical Quality System

October 26, 2012

Dominic Parry

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. Read more

Management Review – what is it for?

September 10, 2012

Dominic Parry

In this post we look at the reasons for performing Management Review, where the idea of Management Review has come from, what should be discussed, what the outcomes should be, who should attend and how often they should take place.  Read more

The positioning of the Qualified Person (QP) within the organisation

April 24, 2012

Dominic Parry

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. Read more

Duties of key personnel in GMP – Part 4 (Human Resources)

April 20, 2012

Dominic Parry

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. Read more

Duties of key personnel in GMP – Part 3 (Engineering)

April 17, 2012

Dominic Parry

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: Read more

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